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Last Updated: December 28, 2025

Expiring Drug Patents Cheat Sheet
We analyse the patents covering drugs in 134 countries and quickly give you the likely loss-of-exclusivity/generic entry date

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South Korea: These 32 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026

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Preferred citation:
Friedman, Yali, "South Korea: These 32 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026" DrugPatentWatch.com thinkBiotech, 2025 www.drugpatentwatch.com/p/expiring-drug-patents-generic-entry/.
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These estimated drug patent expiration dates and generic entry opportunity dates are calculated from analysis of known patents covering drugs. Many factors can influence early or late generic entry. This information is provided as a rough estimate of generic entry potential and should not be used as an independent source. The methodology is described in this blog post.
When can CAMCEVI KIT (leuprolide mesylate) generic drug versions launch?

Generic name: leuprolide mesylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: January 18, 2026
Generic Entry Controlled by: South Korea Patent 101,728,868

CAMCEVI KIT is a drug marketed by Accord. There are five patents protecting this drug.

This drug has thirty-nine patent family members in nineteen countries.

The generic ingredient in CAMCEVI KIT is leuprolide mesylate. There are twenty-two drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the leuprolide mesylate profile page.

When can CAMCEVI KIT (leuprolide mesylate) generic drug versions launch?

Generic name: leuprolide mesylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: January 18, 2026
Generic Entry Controlled by: South Korea Patent 20,080,089,643
Patent Title: PHARMACEUTICAL COMPOSITIONS WITH ENHANCED STABILITY

CAMCEVI KIT is a drug marketed by Accord. There are five patents protecting this drug.

This drug has thirty-nine patent family members in nineteen countries.

The generic ingredient in CAMCEVI KIT is leuprolide mesylate. There are twenty-two drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the leuprolide mesylate profile page.

When can CAMCEVI KIT (leuprolide mesylate) generic drug versions launch?

Generic name: leuprolide mesylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: January 18, 2026
Generic Entry Controlled by: South Korea Patent 20,150,017,777
Patent Title: PHARMACEUTICAL COMPOSITIONS WITH ENHANCED STABILITY

CAMCEVI KIT is a drug marketed by Accord. There are five patents protecting this drug.

This drug has thirty-nine patent family members in nineteen countries.

The generic ingredient in CAMCEVI KIT is leuprolide mesylate. There are twenty-two drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the leuprolide mesylate profile page.

When can LEXISCAN (regadenoson) generic drug versions launch?

Generic name: regadenoson
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 03, 2026
Generic Entry Controlled by: South Korea Patent 20,080,090,491
Patent Title: PROCESS FOR PREPARING AN A2A-ADENOSINE RECEPTOR AGONIST AND ITS POLYMORPHS

LEXISCAN is a drug marketed by Astellas. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has twenty-eight patent family members in eighteen countries. There has been litigation on patents covering LEXISCAN

See drug price trends for LEXISCAN.

The generic ingredient in LEXISCAN is regadenoson. There are nine drug master file entries for this API. Eighteen suppliers are listed for this generic product. Additional details are available on the regadenoson profile page.

When can RAPIVAB (peramivir) generic drug versions launch?

Generic name: peramivir
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 13, 2026
Generic Entry Controlled by: South Korea Patent 101,992,585

RAPIVAB is a drug marketed by Biocryst. There are two patents protecting this drug.

This drug has forty-three patent family members in fourteen countries.

See drug price trends for RAPIVAB.

The generic ingredient in RAPIVAB is peramivir. There is one drug master file entry for this API. One supplier is listed for this generic product. Additional details are available on the peramivir profile page.

When can RAPIVAB (peramivir) generic drug versions launch?

Generic name: peramivir
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 13, 2026
Generic Entry Controlled by: South Korea Patent 102,194,015

RAPIVAB is a drug marketed by Biocryst. There are two patents protecting this drug.

This drug has forty-three patent family members in fourteen countries.

See drug price trends for RAPIVAB.

The generic ingredient in RAPIVAB is peramivir. There is one drug master file entry for this API. One supplier is listed for this generic product. Additional details are available on the peramivir profile page.

When can RAPIVAB (peramivir) generic drug versions launch?

Generic name: peramivir
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 13, 2026
Generic Entry Controlled by: South Korea Patent 102,267,754

RAPIVAB is a drug marketed by Biocryst. There are two patents protecting this drug.

This drug has forty-three patent family members in fourteen countries.

See drug price trends for RAPIVAB.

The generic ingredient in RAPIVAB is peramivir. There is one drug master file entry for this API. One supplier is listed for this generic product. Additional details are available on the peramivir profile page.

When can RAPIVAB (peramivir) generic drug versions launch?

Generic name: peramivir
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 13, 2026
Generic Entry Controlled by: South Korea Patent 102,323,339

RAPIVAB is a drug marketed by Biocryst. There are two patents protecting this drug.

This drug has forty-three patent family members in fourteen countries.

See drug price trends for RAPIVAB.

The generic ingredient in RAPIVAB is peramivir. There is one drug master file entry for this API. One supplier is listed for this generic product. Additional details are available on the peramivir profile page.

When can RAPIVAB (peramivir) generic drug versions launch?

Generic name: peramivir
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 13, 2026
Generic Entry Controlled by: South Korea Patent 102,475,176

RAPIVAB is a drug marketed by Biocryst. There are two patents protecting this drug.

This drug has forty-three patent family members in fourteen countries.

See drug price trends for RAPIVAB.

The generic ingredient in RAPIVAB is peramivir. There is one drug master file entry for this API. One supplier is listed for this generic product. Additional details are available on the peramivir profile page.

When can RAPIVAB (peramivir) generic drug versions launch?

Generic name: peramivir
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 13, 2026
Generic Entry Controlled by: South Korea Patent 20,140,132,778
Patent Title: INTRAVENOUS ANTIVIRAL TREATMENTS

RAPIVAB is a drug marketed by Biocryst. There are two patents protecting this drug.

This drug has forty-three patent family members in fourteen countries.

See drug price trends for RAPIVAB.

The generic ingredient in RAPIVAB is peramivir. There is one drug master file entry for this API. One supplier is listed for this generic product. Additional details are available on the peramivir profile page.

When can RAPIVAB (peramivir) generic drug versions launch?

Generic name: peramivir
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 13, 2026
Generic Entry Controlled by: South Korea Patent 20,160,129,105
Patent Title: 정맥내 항바이러스 치료 (INTRAVENOUS ANTIVIRAL TREATMENTS)

RAPIVAB is a drug marketed by Biocryst. There are two patents protecting this drug.

This drug has forty-three patent family members in fourteen countries.

See drug price trends for RAPIVAB.

The generic ingredient in RAPIVAB is peramivir. There is one drug master file entry for this API. One supplier is listed for this generic product. Additional details are available on the peramivir profile page.

When can RAPIVAB (peramivir) generic drug versions launch?

Generic name: peramivir
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 13, 2026
Generic Entry Controlled by: South Korea Patent 20,210,076,189
Patent Title: 정맥내 항바이러스 치료 (INTRAVENOUS ANTIVIRAL TREATMENTS)

RAPIVAB is a drug marketed by Biocryst. There are two patents protecting this drug.

This drug has forty-three patent family members in fourteen countries.

See drug price trends for RAPIVAB.

The generic ingredient in RAPIVAB is peramivir. There is one drug master file entry for this API. One supplier is listed for this generic product. Additional details are available on the peramivir profile page.

When can DYANAVEL XR (amphetamine) generic drug versions launch?

Generic name: amphetamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 16, 2026
Generic Entry Controlled by: South Korea Patent 101,495,146

Drug Price Trends for DYANAVEL XR
DYANAVEL XR is a drug marketed by Tris Pharma Inc. There are ten patents protecting this drug.

This drug has twenty-one patent family members in fourteen countries. There has been litigation on patents covering DYANAVEL XR

See drug price trends for DYANAVEL XR.

The generic ingredient in DYANAVEL XR is amphetamine. There are fifty-five drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the amphetamine profile page.

When can DYANAVEL XR (amphetamine) generic drug versions launch?

Generic name: amphetamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 16, 2026
Generic Entry Controlled by: South Korea Patent 20,080,108,520
Patent Title: MODIFIED RELEASE FORMULATIONS CONTAINING DRUG - ION EXCHANGE RESIN COMPLEXES

Drug Price Trends for DYANAVEL XR
DYANAVEL XR is a drug marketed by Tris Pharma Inc. There are ten patents protecting this drug.

This drug has twenty-one patent family members in fourteen countries. There has been litigation on patents covering DYANAVEL XR

See drug price trends for DYANAVEL XR.

The generic ingredient in DYANAVEL XR is amphetamine. There are fifty-five drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the amphetamine profile page.

When can TUZISTRA XR (chlorpheniramine polistirex; codeine polistirex) generic drug versions launch?

Generic name: chlorpheniramine polistirex; codeine polistirex
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 16, 2026
Generic Entry Controlled by: South Korea Patent 101,495,146

TUZISTRA XR is a drug marketed by Tris Pharma Inc. There are two patents protecting this drug.

This drug has twenty-one patent family members in fourteen countries. There has been litigation on patents covering TUZISTRA XR

See drug price trends for TUZISTRA XR.

The generic ingredient in TUZISTRA XR is chlorpheniramine polistirex; codeine polistirex. There are twenty-nine drug master file entries for this API. Additional details are available on the chlorpheniramine polistirex; codeine polistirex profile page.

When can TUZISTRA XR (chlorpheniramine polistirex; codeine polistirex) generic drug versions launch?

Generic name: chlorpheniramine polistirex; codeine polistirex
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 16, 2026
Generic Entry Controlled by: South Korea Patent 20,080,108,520
Patent Title: MODIFIED RELEASE FORMULATIONS CONTAINING DRUG - ION EXCHANGE RESIN COMPLEXES

TUZISTRA XR is a drug marketed by Tris Pharma Inc. There are two patents protecting this drug.

This drug has twenty-one patent family members in fourteen countries. There has been litigation on patents covering TUZISTRA XR

See drug price trends for TUZISTRA XR.

The generic ingredient in TUZISTRA XR is chlorpheniramine polistirex; codeine polistirex. There are twenty-nine drug master file entries for this API. Additional details are available on the chlorpheniramine polistirex; codeine polistirex profile page.

When can LASTACAFT (alcaftadine) generic drug versions launch?

Generic name: alcaftadine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 31, 2026
Generic Entry Controlled by: South Korea Patent 20,080,110,881
Patent Title: OCULAR ALLERGY TREATMENTS

Drug Price Trends for LASTACAFT
LASTACAFT is a drug marketed by Abbvie. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has forty-six patent family members in thirty countries. There has been litigation on patents covering LASTACAFT

See drug price trends for LASTACAFT.

The generic ingredient in LASTACAFT is alcaftadine. There are six drug master file entries for this API. Four suppliers are listed for this generic product. Additional details are available on the alcaftadine profile page.

When can APTIOM (eslicarbazepine acetate) generic drug versions launch?

Generic name: eslicarbazepine acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 21, 2026
Generic Entry Controlled by: South Korea Patent 20,080,036,212
Patent Title: ASYMMETRIC CATALYTIC REDUCTION OF OXCARBAZEPINE

Drug Price Trends for APTIOM
APTIOM is a drug marketed by Sumitomo Pharma Am. There are eleven patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market.

This drug has one hundred patent family members in twenty-six countries. There has been litigation on patents covering APTIOM

See drug price trends for APTIOM.

The generic ingredient in APTIOM is eslicarbazepine acetate. There are twelve drug master file entries for this API. Eight suppliers are listed for this generic product. Additional details are available on the eslicarbazepine acetate profile page.

When can ORENITRAM (treprostinil diolamine) generic drug versions launch?

Generic name: treprostinil diolamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 27, 2026
Generic Entry Controlled by: South Korea Patent 20,090,038,392
Patent Title: OSMOTIC DRUG DELIVERY SYSTEM COMPRISING RELEASE ENHANCING AGENT

ORENITRAM is a drug marketed by United Therap. There are nine patents protecting this drug and two Paragraph IV challenges.

This drug has fifty-nine patent family members in eight countries. There has been litigation on patents covering ORENITRAM

See drug price trends for ORENITRAM.

The generic ingredient in ORENITRAM is treprostinil diolamine. There are nineteen drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the treprostinil diolamine profile page.

When can ORENITRAM (treprostinil diolamine) generic drug versions launch?

Generic name: treprostinil diolamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 27, 2026
Generic Entry Controlled by: South Korea Patent 20,140,075,805
Patent Title: OSMOTIC DRUG DELIVERY SYSTEM COMPRISING RELEASE ENHANCING AGENT

ORENITRAM is a drug marketed by United Therap. There are nine patents protecting this drug and two Paragraph IV challenges.

This drug has fifty-nine patent family members in eight countries. There has been litigation on patents covering ORENITRAM

See drug price trends for ORENITRAM.

The generic ingredient in ORENITRAM is treprostinil diolamine. There are nineteen drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the treprostinil diolamine profile page.

When can TRADJENTA (linagliptin) generic drug versions launch?

Generic name: linagliptin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 04, 2026
Generic Entry Controlled by: South Korea Patent 101,478,983

Drug Price Trends for TRADJENTA
TRADJENTA is a drug marketed by Boehringer Ingelheim. There are eleven patents protecting this drug and one Paragraph IV challenge. Three tentatively approved generics are ready to enter the market.

This drug has four hundred and eighty-six patent family members in forty-five countries. There has been litigation on patents covering TRADJENTA

See drug price trends for TRADJENTA.

The generic ingredient in TRADJENTA is linagliptin. There are nineteen drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the linagliptin profile page.

When can TRADJENTA (linagliptin) generic drug versions launch?

Generic name: linagliptin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 04, 2026
Generic Entry Controlled by: South Korea Patent 101,710,881

Drug Price Trends for TRADJENTA
TRADJENTA is a drug marketed by Boehringer Ingelheim. There are eleven patents protecting this drug and one Paragraph IV challenge. Three tentatively approved generics are ready to enter the market.

This drug has four hundred and eighty-six patent family members in forty-five countries. There has been litigation on patents covering TRADJENTA

See drug price trends for TRADJENTA.

The generic ingredient in TRADJENTA is linagliptin. There are nineteen drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the linagliptin profile page.

When can TRADJENTA (linagliptin) generic drug versions launch?

Generic name: linagliptin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 04, 2026
Generic Entry Controlled by: South Korea Patent 101,855,323

Drug Price Trends for TRADJENTA
TRADJENTA is a drug marketed by Boehringer Ingelheim. There are eleven patents protecting this drug and one Paragraph IV challenge. Three tentatively approved generics are ready to enter the market.

This drug has four hundred and eighty-six patent family members in forty-five countries. There has been litigation on patents covering TRADJENTA

See drug price trends for TRADJENTA.

The generic ingredient in TRADJENTA is linagliptin. There are nineteen drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the linagliptin profile page.

When can TRADJENTA (linagliptin) generic drug versions launch?

Generic name: linagliptin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 04, 2026
Generic Entry Controlled by: South Korea Patent 102,051,281

Drug Price Trends for TRADJENTA
TRADJENTA is a drug marketed by Boehringer Ingelheim. There are eleven patents protecting this drug and one Paragraph IV challenge. Three tentatively approved generics are ready to enter the market.

This drug has four hundred and eighty-six patent family members in forty-five countries. There has been litigation on patents covering TRADJENTA

See drug price trends for TRADJENTA.

The generic ingredient in TRADJENTA is linagliptin. There are nineteen drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the linagliptin profile page.

When can TRADJENTA (linagliptin) generic drug versions launch?

Generic name: linagliptin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 04, 2026
Generic Entry Controlled by: South Korea Patent 20,090,009,226

Drug Price Trends for TRADJENTA
TRADJENTA is a drug marketed by Boehringer Ingelheim. There are eleven patents protecting this drug and one Paragraph IV challenge. Three tentatively approved generics are ready to enter the market.

This drug has four hundred and eighty-six patent family members in forty-five countries. There has been litigation on patents covering TRADJENTA

See drug price trends for TRADJENTA.

The generic ingredient in TRADJENTA is linagliptin. There are nineteen drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the linagliptin profile page.

When can TRADJENTA (linagliptin) generic drug versions launch?

Generic name: linagliptin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 04, 2026
Generic Entry Controlled by: South Korea Patent 20,140,063,896

Drug Price Trends for TRADJENTA
TRADJENTA is a drug marketed by Boehringer Ingelheim. There are eleven patents protecting this drug and one Paragraph IV challenge. Three tentatively approved generics are ready to enter the market.

This drug has four hundred and eighty-six patent family members in forty-five countries. There has been litigation on patents covering TRADJENTA

See drug price trends for TRADJENTA.

The generic ingredient in TRADJENTA is linagliptin. There are nineteen drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the linagliptin profile page.

When can TRADJENTA (linagliptin) generic drug versions launch?

Generic name: linagliptin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 04, 2026
Generic Entry Controlled by: South Korea Patent 20,160,128,446

Drug Price Trends for TRADJENTA
TRADJENTA is a drug marketed by Boehringer Ingelheim. There are eleven patents protecting this drug and one Paragraph IV challenge. Three tentatively approved generics are ready to enter the market.

This drug has four hundred and eighty-six patent family members in forty-five countries. There has been litigation on patents covering TRADJENTA

See drug price trends for TRADJENTA.

The generic ingredient in TRADJENTA is linagliptin. There are nineteen drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the linagliptin profile page.

When can TRADJENTA (linagliptin) generic drug versions launch?

Generic name: linagliptin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 04, 2026
Generic Entry Controlled by: South Korea Patent 20,170,141,812

Drug Price Trends for TRADJENTA
TRADJENTA is a drug marketed by Boehringer Ingelheim. There are eleven patents protecting this drug and one Paragraph IV challenge. Three tentatively approved generics are ready to enter the market.

This drug has four hundred and eighty-six patent family members in forty-five countries. There has been litigation on patents covering TRADJENTA

See drug price trends for TRADJENTA.

The generic ingredient in TRADJENTA is linagliptin. There are nineteen drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the linagliptin profile page.

When can TRINTELLIX (vortioxetine hydrobromide) generic drug versions launch?

Generic name: vortioxetine hydrobromide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 16, 2026
Generic Entry Controlled by: South Korea Patent 101,627,901

Drug Price Trends for TRINTELLIX
TRINTELLIX is a drug marketed by Takeda Pharms Usa. There are ten patents protecting this drug and one Paragraph IV challenge. Two tentatively approved generics are ready to enter the market.

This drug has two hundred and seventeen patent family members in forty-two countries. There has been litigation on patents covering TRINTELLIX

See drug price trends for TRINTELLIX.

The generic ingredient in TRINTELLIX is vortioxetine hydrobromide. There are sixteen drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the vortioxetine hydrobromide profile page.

When can TRINTELLIX (vortioxetine hydrobromide) generic drug versions launch?

Generic name: vortioxetine hydrobromide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 16, 2026
Generic Entry Controlled by: South Korea Patent 20,090,028,712
Patent Title: 1-[2-(2,4-DIMETHYLPHENYLSULFANYL)-PHENYL]PIPERAZINE AS A COMPOUND WITH COMBINED SEROTONIN REUPTAKE, 5-HT3 AND 5-HT1A ACTIVITY FOR THE TREATMENT OF COGNITIVE IMPAIRMENT

Drug Price Trends for TRINTELLIX
TRINTELLIX is a drug marketed by Takeda Pharms Usa. There are ten patents protecting this drug and one Paragraph IV challenge. Two tentatively approved generics are ready to enter the market.

This drug has two hundred and seventeen patent family members in forty-two countries. There has been litigation on patents covering TRINTELLIX

See drug price trends for TRINTELLIX.

The generic ingredient in TRINTELLIX is vortioxetine hydrobromide. There are sixteen drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the vortioxetine hydrobromide profile page.

When can TRINTELLIX (vortioxetine hydrobromide) generic drug versions launch?

Generic name: vortioxetine hydrobromide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 16, 2026
Generic Entry Controlled by: South Korea Patent 20,090,125,251
Patent Title: 1-[2-(2,4-DIMETHYLPHENYLSULFANYL)-PHENYL]PIPERAZINE AS A COMPOUND WITH COMBINED SEROTONIN REUPTAKE, 5-HT3 AND 5-HT1A ACTIVITY FOR THE TREATMENT OF PAIN OR RESIDUAL SYMPTOMS IN DEPRESSION RELATING TO SLEEP AND COGNITION

Drug Price Trends for TRINTELLIX
TRINTELLIX is a drug marketed by Takeda Pharms Usa. There are ten patents protecting this drug and one Paragraph IV challenge. Two tentatively approved generics are ready to enter the market.

This drug has two hundred and seventeen patent family members in forty-two countries. There has been litigation on patents covering TRINTELLIX

See drug price trends for TRINTELLIX.

The generic ingredient in TRINTELLIX is vortioxetine hydrobromide. There are sixteen drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the vortioxetine hydrobromide profile page.

When can TRINTELLIX (vortioxetine hydrobromide) generic drug versions launch?

Generic name: vortioxetine hydrobromide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 16, 2026
Generic Entry Controlled by: South Korea Patent 20,130,133,078
Patent Title: 1-[2-(2,4-DIMETHYLPHENYLSULFANYL)-PHENYL]PIPERAZINE AS A COMPOUND WITH COMBINED SEROTONIN REUPTAKE, 5-HT3 AND 5-HT1A ACTIVITY FOR THE TREATMENT OF COGNITIVE IMPAIRMENT

Drug Price Trends for TRINTELLIX
TRINTELLIX is a drug marketed by Takeda Pharms Usa. There are ten patents protecting this drug and one Paragraph IV challenge. Two tentatively approved generics are ready to enter the market.

This drug has two hundred and seventeen patent family members in forty-two countries. There has been litigation on patents covering TRINTELLIX

See drug price trends for TRINTELLIX.

The generic ingredient in TRINTELLIX is vortioxetine hydrobromide. There are sixteen drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the vortioxetine hydrobromide profile page.

When can EMBEDA (morphine sulfate; naltrexone hydrochloride) generic drug versions launch?

Generic name: morphine sulfate; naltrexone hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2026
Generic Entry Controlled by: South Korea Patent 20,090,037,885
Patent Title: PHARMACEUTICAL COMPOSITIONS

EMBEDA is a drug marketed by Alpharma Pharms. There are nine patents protecting this drug and four Paragraph IV challenges.

This drug has seventy-four patent family members in twenty-three countries.

See drug price trends for EMBEDA.

The generic ingredient in EMBEDA is morphine sulfate; naltrexone hydrochloride. There are twenty-three drug master file entries for this API. Additional details are available on the morphine sulfate; naltrexone hydrochloride profile page.

When can OLYSIO (simeprevir sodium) generic drug versions launch?

Generic name: simeprevir sodium
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 28, 2026
Generic Entry Controlled by: South Korea Patent 20,080,042,084
Patent Title: MACROCYLIC INHIBITORS OF HEPATITIS C VIRUS

OLYSIO is a drug marketed by Janssen Prods. There are nine patents protecting this drug.

This drug has one hundred and forty patent family members in forty-three countries.

See drug price trends for OLYSIO.

The generic ingredient in OLYSIO is simeprevir sodium. There is one drug master file entry for this API. Additional details are available on the simeprevir sodium profile page.

When can SALONPAS (menthol; methyl salicylate) generic drug versions launch?

Generic name: menthol; methyl salicylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 04, 2026
Generic Entry Controlled by: South Korea Patent 101,420,450

SALONPAS is a drug marketed by Hisamitsu Pharm Co. There are two patents protecting this drug.

This drug has twenty patent family members in sixteen countries.

The generic ingredient in SALONPAS is menthol; methyl salicylate. There are eighteen drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the menthol; methyl salicylate profile page.

When can SALONPAS (menthol; methyl salicylate) generic drug versions launch?

Generic name: menthol; methyl salicylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 04, 2026
Generic Entry Controlled by: South Korea Patent 20,090,035,474
Patent Title: ADHESIVE PREPARATION

SALONPAS is a drug marketed by Hisamitsu Pharm Co. There are two patents protecting this drug.

This drug has twenty patent family members in sixteen countries.

The generic ingredient in SALONPAS is menthol; methyl salicylate. There are eighteen drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the menthol; methyl salicylate profile page.

When can CREON (pancrelipase (amylase;lipase;protease)) generic drug versions launch?

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 15, 2026
Generic Entry Controlled by: South Korea Patent 101,302,841

CREON is a drug marketed by

This drug has twenty patent family members in sixteen countries.

See drug price trends for CREON.

The generic ingredient in CREON is pancrelipase (amylase;lipase;protease). There are six drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the pancrelipase (amylase;lipase;protease) profile page.

When can CREON (pancrelipase (amylase;lipase;protease)) generic drug versions launch?

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 15, 2026
Generic Entry Controlled by: South Korea Patent 101,344,546

CREON is a drug marketed by

This drug has twenty patent family members in sixteen countries.

See drug price trends for CREON.

The generic ingredient in CREON is pancrelipase (amylase;lipase;protease). There are six drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the pancrelipase (amylase;lipase;protease) profile page.

When can CREON (pancrelipase (amylase;lipase;protease)) generic drug versions launch?

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 15, 2026
Generic Entry Controlled by: South Korea Patent 20,080,034,515
Patent Title: CONTROLLED RELEASE PHARMACEUTICAL COMPOSITIONS FOR ACID LABILE DRUGS

CREON is a drug marketed by

This drug has twenty patent family members in sixteen countries.

See drug price trends for CREON.

The generic ingredient in CREON is pancrelipase (amylase;lipase;protease). There are six drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the pancrelipase (amylase;lipase;protease) profile page.

When can CREON (pancrelipase (amylase;lipase;protease)) generic drug versions launch?

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 15, 2026
Generic Entry Controlled by: South Korea Patent 20,080,034,516
Patent Title: PANCREATIN MICROPELLET CORES SUITABLE FOR ENTERIC COATING

CREON is a drug marketed by

This drug has twenty patent family members in sixteen countries.

See drug price trends for CREON.

The generic ingredient in CREON is pancrelipase (amylase;lipase;protease). There are six drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the pancrelipase (amylase;lipase;protease) profile page.

When can BRILINTA (ticagrelor) generic drug versions launch?

Generic name: ticagrelor
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 21, 2026
Generic Entry Controlled by: South Korea Patent 101,539,467

Drug Price Trends for BRILINTA
BRILINTA is a drug marketed by Astrazeneca. There are three patents protecting this drug and two Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

This drug has one hundred and forty-seven patent family members in forty-four countries. There has been litigation on patents covering BRILINTA

See drug price trends for BRILINTA.

The generic ingredient in BRILINTA is ticagrelor. There are twenty-one drug master file entries for this API. Twenty-five suppliers are listed for this generic product. Additional details are available on the ticagrelor profile page.

When can JYNARQUE (tolvaptan) generic drug versions launch?

Generic name: tolvaptan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 01, 2026
Generic Entry Controlled by: South Korea Patent 20,100,132,087

JYNARQUE is a drug marketed by Otsuka. There are two patents protecting this drug.

This drug has eighty-six patent family members in twenty-four countries. There has been litigation on patents covering JYNARQUE

See drug price trends for JYNARQUE.

The generic ingredient in JYNARQUE is tolvaptan. There are eight drug master file entries for this API. Seven suppliers are listed for this generic product. Additional details are available on the tolvaptan profile page.

When can JYNARQUE (tolvaptan) generic drug versions launch?

Generic name: tolvaptan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 01, 2026
Generic Entry Controlled by: South Korea Patent 20,100,133,028

JYNARQUE is a drug marketed by Otsuka. There are two patents protecting this drug.

This drug has eighty-six patent family members in twenty-four countries. There has been litigation on patents covering JYNARQUE

See drug price trends for JYNARQUE.

The generic ingredient in JYNARQUE is tolvaptan. There are eight drug master file entries for this API. Seven suppliers are listed for this generic product. Additional details are available on the tolvaptan profile page.

When can SAMSCA (tolvaptan) generic drug versions launch?

Generic name: tolvaptan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 01, 2026
Generic Entry Controlled by: South Korea Patent 20,100,132,087

SAMSCA is a drug marketed by Otsuka. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has eighty-six patent family members in twenty-four countries. There has been litigation on patents covering SAMSCA

See drug price trends for SAMSCA.

The generic ingredient in SAMSCA is tolvaptan. There are eight drug master file entries for this API. Seven suppliers are listed for this generic product. Additional details are available on the tolvaptan profile page.

When can SAMSCA (tolvaptan) generic drug versions launch?

Generic name: tolvaptan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 01, 2026
Generic Entry Controlled by: South Korea Patent 20,100,133,028

SAMSCA is a drug marketed by Otsuka. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has eighty-six patent family members in twenty-four countries. There has been litigation on patents covering SAMSCA

See drug price trends for SAMSCA.

The generic ingredient in SAMSCA is tolvaptan. There are eight drug master file entries for this API. Seven suppliers are listed for this generic product. Additional details are available on the tolvaptan profile page.

When can ESBRIET (pirfenidone) generic drug versions launch?

Generic name: pirfenidone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 22, 2026
Generic Entry Controlled by: South Korea Patent 101,675,651

ESBRIET is a drug marketed by Genentech Inc. There are twenty patents protecting this drug and two Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

This drug has two hundred and sixty-six patent family members in forty-six countries. There has been litigation on patents covering ESBRIET

See drug price trends for ESBRIET.

The generic ingredient in ESBRIET is pirfenidone. There are twenty-three drug master file entries for this API. Twenty-four suppliers are listed for this generic product. Additional details are available on the pirfenidone profile page.

When can ESBRIET (pirfenidone) generic drug versions launch?

Generic name: pirfenidone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 22, 2026
Generic Entry Controlled by: South Korea Patent 20,130,100,381
Patent Title: CAPSULE FORMULATION OF PIRFENIDONE AND PHARMACEUTICALLY ACCEPTABLE EXCIPIENTS

ESBRIET is a drug marketed by Genentech Inc. There are twenty patents protecting this drug and two Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

This drug has two hundred and sixty-six patent family members in forty-six countries. There has been litigation on patents covering ESBRIET

See drug price trends for ESBRIET.

The generic ingredient in ESBRIET is pirfenidone. There are twenty-three drug master file entries for this API. Twenty-four suppliers are listed for this generic product. Additional details are available on the pirfenidone profile page.

When can INPEFA (sotagliflozin) generic drug versions launch?

Generic name: sotagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 29, 2026
Generic Entry Controlled by: South Korea Patent 20,090,061,072
Patent Title: PHLORIZIN ANALOGS AS INHIBITORS OF SODIUM GLUCOSE CO-TRANSPORTER 2

Drug Price Trends for INPEFA
INPEFA is a drug marketed by Lexicon Pharms Inc. There are three patents protecting this drug.

This drug has eighty-one patent family members in thirty-three countries.

See drug price trends for INPEFA.

The generic ingredient in INPEFA is sotagliflozin. One supplier is listed for this generic product. Additional details are available on the sotagliflozin profile page.

When can LYNPARZA (olaparib) generic drug versions launch?

Generic name: olaparib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 17, 2026
Generic Entry Controlled by: South Korea Patent 20,090,085,033

LYNPARZA is a drug marketed by Astrazeneca. There are twelve patents protecting this drug. Three tentatively approved generics are ready to enter the market.

This drug has two hundred and fifty-four patent family members in fifty-two countries. There has been litigation on patents covering LYNPARZA

See drug price trends for LYNPARZA.

The generic ingredient in LYNPARZA is olaparib. There are three drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the olaparib profile page.

When can ENTRESTO SPRINKLE (sacubitril; valsartan) generic drug versions launch?

Generic name: sacubitril; valsartan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 08, 2026
Generic Entry Controlled by: South Korea Patent 101,432,821

Drug Price Trends for ENTRESTO SPRINKLE
ENTRESTO SPRINKLE is a drug marketed by Novartis. There are four patents protecting this drug.

This drug has one hundred and forty-five patent family members in forty-three countries. There has been litigation on patents covering ENTRESTO SPRINKLE

See drug price trends for ENTRESTO SPRINKLE.

The generic ingredient in ENTRESTO SPRINKLE is sacubitril; valsartan. There are eleven drug master file entries for this API. Twenty-two suppliers are listed for this generic product. Additional details are available on the sacubitril; valsartan profile page.

When can ENTRESTO SPRINKLE (sacubitril; valsartan) generic drug versions launch?

Generic name: sacubitril; valsartan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 08, 2026
Generic Entry Controlled by: South Korea Patent 101,549,318

Drug Price Trends for ENTRESTO SPRINKLE
ENTRESTO SPRINKLE is a drug marketed by Novartis. There are four patents protecting this drug.

This drug has one hundred and forty-five patent family members in forty-three countries. There has been litigation on patents covering ENTRESTO SPRINKLE

See drug price trends for ENTRESTO SPRINKLE.

The generic ingredient in ENTRESTO SPRINKLE is sacubitril; valsartan. There are eleven drug master file entries for this API. Twenty-two suppliers are listed for this generic product. Additional details are available on the sacubitril; valsartan profile page.

When can KORSUVA (difelikefalin acetate) generic drug versions launch?

Generic name: difelikefalin acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 10, 2026
Generic Entry Controlled by: South Korea Patent 20,090,085,096
Patent Title: SYNTHETIC PEPTIDE AMIDES

KORSUVA is a drug marketed by Vifor Intl. There are twelve patents protecting this drug.

This drug has fifty-three patent family members in twenty-seven countries. There has been litigation on patents covering KORSUVA

See drug price trends for KORSUVA.

The generic ingredient in KORSUVA is difelikefalin acetate. One supplier is listed for this generic product. Additional details are available on the difelikefalin acetate profile page.

When can KORSUVA (difelikefalin acetate) generic drug versions launch?

Generic name: difelikefalin acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 10, 2026
Generic Entry Controlled by: South Korea Patent 20,140,056,396
Patent Title: SYNTHETIC PEPTIDE AMIDES AND DIMERS THEREOF

KORSUVA is a drug marketed by Vifor Intl. There are twelve patents protecting this drug.

This drug has fifty-three patent family members in twenty-seven countries. There has been litigation on patents covering KORSUVA

See drug price trends for KORSUVA.

The generic ingredient in KORSUVA is difelikefalin acetate. One supplier is listed for this generic product. Additional details are available on the difelikefalin acetate profile page.

When can XALKORI (crizotinib) generic drug versions launch?

Generic name: crizotinib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 23, 2026
Generic Entry Controlled by: South Korea Patent 101,146,852

XALKORI is a drug marketed by Pf Prism Cv. There are five patents protecting this drug.

This drug has one hundred and fifty-two patent family members in forty-eight countries.

See drug price trends for XALKORI.

The generic ingredient in XALKORI is crizotinib. One supplier is listed for this generic product. Additional details are available on the crizotinib profile page.

When can XALKORI (crizotinib) generic drug versions launch?

Generic name: crizotinib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 23, 2026
Generic Entry Controlled by: South Korea Patent 20,080,074,950

XALKORI is a drug marketed by Pf Prism Cv. There are five patents protecting this drug.

This drug has one hundred and fifty-two patent family members in forty-eight countries.

See drug price trends for XALKORI.

The generic ingredient in XALKORI is crizotinib. One supplier is listed for this generic product. Additional details are available on the crizotinib profile page.

When can AXUMIN (fluciclovine f-18) generic drug versions launch?

Generic name: fluciclovine f-18
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 28, 2026
Generic Entry Controlled by: South Korea Patent 101,608,755

AXUMIN is a drug marketed by Blue Earth. There are eight patents protecting this drug.

This drug has thirty patent family members in sixteen countries. There has been litigation on patents covering AXUMIN

The generic ingredient in AXUMIN is fluciclovine f-18. One supplier is listed for this generic product. Additional details are available on the fluciclovine f-18 profile page.

When can ZTALMY (ganaxolone) generic drug versions launch?

Generic name: ganaxolone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 28, 2026
Generic Entry Controlled by: South Korea Patent 101,405,545

ZTALMY is a drug marketed by Marinus. There are eleven patents protecting this drug.

This drug has forty-eight patent family members in sixteen countries. There has been litigation on patents covering ZTALMY

See drug price trends for ZTALMY.

The generic ingredient in ZTALMY is ganaxolone. One supplier is listed for this generic product. Additional details are available on the ganaxolone profile page.

When can ZTALMY (ganaxolone) generic drug versions launch?

Generic name: ganaxolone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 28, 2026
Generic Entry Controlled by: South Korea Patent 101,415,329

ZTALMY is a drug marketed by Marinus. There are eleven patents protecting this drug.

This drug has forty-eight patent family members in sixteen countries. There has been litigation on patents covering ZTALMY

See drug price trends for ZTALMY.

The generic ingredient in ZTALMY is ganaxolone. One supplier is listed for this generic product. Additional details are available on the ganaxolone profile page.

When can ZTALMY (ganaxolone) generic drug versions launch?

Generic name: ganaxolone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 28, 2026
Generic Entry Controlled by: South Korea Patent 20,080,072,760
Patent Title: GANAXOLONE FORMULATIONS AND METHODS FOR THE MAKING AND USE THEREOF

ZTALMY is a drug marketed by Marinus. There are eleven patents protecting this drug.

This drug has forty-eight patent family members in sixteen countries. There has been litigation on patents covering ZTALMY

See drug price trends for ZTALMY.

The generic ingredient in ZTALMY is ganaxolone. One supplier is listed for this generic product. Additional details are available on the ganaxolone profile page.

When can ZTALMY (ganaxolone) generic drug versions launch?

Generic name: ganaxolone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 28, 2026
Generic Entry Controlled by: South Korea Patent 20,120,107,533
Patent Title: GANAXOLONE FORMULATIONS AND METHODS FOR THE MAKING AND USE THEREOF

ZTALMY is a drug marketed by Marinus. There are eleven patents protecting this drug.

This drug has forty-eight patent family members in sixteen countries. There has been litigation on patents covering ZTALMY

See drug price trends for ZTALMY.

The generic ingredient in ZTALMY is ganaxolone. One supplier is listed for this generic product. Additional details are available on the ganaxolone profile page.

When can ZTALMY (ganaxolone) generic drug versions launch?

Generic name: ganaxolone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 28, 2026
Generic Entry Controlled by: South Korea Patent 20,130,123,471
Patent Title: GANAXOLONE FORMULATIONS AND METHODS FOR THE MAKING AND USE THEREOF

ZTALMY is a drug marketed by Marinus. There are eleven patents protecting this drug.

This drug has forty-eight patent family members in sixteen countries. There has been litigation on patents covering ZTALMY

See drug price trends for ZTALMY.

The generic ingredient in ZTALMY is ganaxolone. One supplier is listed for this generic product. Additional details are available on the ganaxolone profile page.

When can BELSOMRA (suvorexant) generic drug versions launch?

Generic name: suvorexant
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 01, 2026
Generic Entry Controlled by: South Korea Patent 20,090,087,110

Drug Price Trends for BELSOMRA
BELSOMRA is a drug marketed by Merck Sharp Dohme. There are three patents protecting this drug.

This drug has seventy-five patent family members in thirty-six countries.

See drug price trends for BELSOMRA.

The generic ingredient in BELSOMRA is suvorexant. One supplier is listed for this generic product. Additional details are available on the suvorexant profile page.

When can INVOKAMET (canagliflozin; metformin hydrochloride) generic drug versions launch?

Generic name: canagliflozin; metformin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 04, 2026
Generic Entry Controlled by: South Korea Patent 20,090,086,282

Drug Price Trends for INVOKAMET
INVOKAMET is a drug marketed by Janssen Pharms. There are five patents protecting this drug and two Paragraph IV challenges.

This drug has two hundred and seventy-one patent family members in forty-eight countries. There has been litigation on patents covering INVOKAMET

See drug price trends for INVOKAMET.

The generic ingredient in INVOKAMET is canagliflozin; metformin hydrochloride. There are twenty-one drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the canagliflozin; metformin hydrochloride profile page.

When can INVOKAMET XR (canagliflozin; metformin hydrochloride) generic drug versions launch?

Generic name: canagliflozin; metformin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 04, 2026
Generic Entry Controlled by: South Korea Patent 20,090,086,282

Drug Price Trends for INVOKAMET XR
INVOKAMET XR is a drug marketed by Janssen Pharms. There are four patents protecting this drug.

This drug has two hundred and twenty patent family members in forty-five countries. There has been litigation on patents covering INVOKAMET XR

See drug price trends for INVOKAMET XR.

The generic ingredient in INVOKAMET XR is canagliflozin; metformin hydrochloride. There are twenty-one drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the canagliflozin; metformin hydrochloride profile page.

When can INVOKANA (canagliflozin) generic drug versions launch?

Generic name: canagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 04, 2026
Generic Entry Controlled by: South Korea Patent 20,090,086,282

Drug Price Trends for INVOKANA
INVOKANA is a drug marketed by Janssen Pharms. There are four patents protecting this drug and one Paragraph IV challenge. Five tentatively approved generics are ready to enter the market.

This drug has two hundred and twenty patent family members in forty-five countries. There has been litigation on patents covering INVOKANA

See drug price trends for INVOKANA.

The generic ingredient in INVOKANA is canagliflozin. There are twenty-one drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the canagliflozin profile page.

When can BEVYXXA (betrixaban) generic drug versions launch?

Generic name: betrixaban
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 08, 2026
Generic Entry Controlled by: South Korea Patent 101,472,765

BEVYXXA is a drug marketed by Portola Pharms Inc. There are five patents protecting this drug.

This drug has sixty-seven patent family members in twenty-six countries. There has been litigation on patents covering BEVYXXA

See drug price trends for BEVYXXA.

The generic ingredient in BEVYXXA is betrixaban. Additional details are available on the betrixaban profile page.

When can KOSELUGO (selumetinib sulfate) generic drug versions launch?

Generic name: selumetinib sulfate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 12, 2026
Generic Entry Controlled by: South Korea Patent 101,361,460

KOSELUGO is a drug marketed by Astrazeneca. There are eight patents protecting this drug.

This drug has two hundred and one patent family members in forty-five countries. There has been litigation on patents covering KOSELUGO

See drug price trends for KOSELUGO.

The generic ingredient in KOSELUGO is selumetinib sulfate. One supplier is listed for this generic product. Additional details are available on the selumetinib sulfate profile page.

When can KOSELUGO (selumetinib sulfate) generic drug versions launch?

Generic name: selumetinib sulfate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 12, 2026
Generic Entry Controlled by: South Korea Patent 20,080,080,200
Patent Title: NOVEL HYDROGEN SULFATE SALT

KOSELUGO is a drug marketed by Astrazeneca. There are eight patents protecting this drug.

This drug has two hundred and one patent family members in forty-five countries. There has been litigation on patents covering KOSELUGO

See drug price trends for KOSELUGO.

The generic ingredient in KOSELUGO is selumetinib sulfate. One supplier is listed for this generic product. Additional details are available on the selumetinib sulfate profile page.

When can PICATO (ingenol mebutate) generic drug versions launch?

Generic name: ingenol mebutate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 18, 2026
Generic Entry Controlled by: South Korea Patent 101,451,993

Drug Price Trends for PICATO
PICATO is a drug marketed by Leo Labs. There are twelve patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market.

This drug has thirty-five patent family members in twenty-one countries. There has been litigation on patents covering PICATO

See drug price trends for PICATO.

The generic ingredient in PICATO is ingenol mebutate. There are three drug master file entries for this API. Additional details are available on the ingenol mebutate profile page.

When can PICATO (ingenol mebutate) generic drug versions launch?

Generic name: ingenol mebutate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 18, 2026
Generic Entry Controlled by: South Korea Patent 101,593,579

Drug Price Trends for PICATO
PICATO is a drug marketed by Leo Labs. There are twelve patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market.

This drug has thirty-five patent family members in twenty-one countries. There has been litigation on patents covering PICATO

See drug price trends for PICATO.

The generic ingredient in PICATO is ingenol mebutate. There are three drug master file entries for this API. Additional details are available on the ingenol mebutate profile page.

When can PICATO (ingenol mebutate) generic drug versions launch?

Generic name: ingenol mebutate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 18, 2026
Generic Entry Controlled by: South Korea Patent 20,140,088,617
Patent Title: THERAPEUTIC COMPOSITIONS

Drug Price Trends for PICATO
PICATO is a drug marketed by Leo Labs. There are twelve patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market.

This drug has thirty-five patent family members in twenty-one countries. There has been litigation on patents covering PICATO

See drug price trends for PICATO.

The generic ingredient in PICATO is ingenol mebutate. There are three drug master file entries for this API. Additional details are available on the ingenol mebutate profile page.

South Korea Branded and Generic Drug Markets Assessment and Regulatory Opportunities and Challenges

Last updated: December 25, 2025

Executive Summary

South Korea stands as one of Asia’s most dynamic pharmaceutical sectors, characterized by a mature branded drug market and a rapidly expanding generic segment. With a total pharmaceutical market value estimated at approximately USD 25 billion in 2022, the nation presents significant opportunities for global and domestic pharmaceutical players. However, navigating South Korea’s complex regulatory environment remains a key challenge.

This report provides a comprehensive assessment of South Korea’s branded and generic drug markets, delves into regulatory frameworks, identifies opportunities for market entry and expansion, and discusses key challenges. Insights are backed by current market data, policy developments, and comparative analysis with regional counterparts, serving as a strategic guide for industry stakeholders.


Market Overview: Branded and Generic Drug Sectors in South Korea

Market Size and Growth Dynamics

Segment 2022 Market Value CAGR (2017-2022) Key Drivers
Branded Drugs USD 14.5 billion 3.2% Aging population, chronic disease prevalence, innovation
Generic Drugs USD 10.5 billion 9.5% Cost containment policies, patent expirations

Source: Korea Pharmaceutical Industry Association (KPIA), 2022

South Korea’s pharmaceutical market achieves a healthy balance, with branded drugs constituting nearly 58% of total sales, driven by high R&D investments and innovative therapeutics. The generic market expanded sharply at nearly 10% annually due to government policies promoting cost-effective prescribing.

Key Market Features

  • Branding/Innovation Focus: South Korea emphasizes innovative drugs, including biologics and specialty medicines, supported by government incentives under the “K-Pharma” initiative.
  • Generic Penetration: Generics account for approximately 44% of drug prescriptions by volume but only 27% by value, indicating room for growth.
  • Vertical Integration: Leading domestic firms like Hanmi Pharmaceutical, Celltrion, and Samsung BioLogics control substantial manufacturing capabilities.

Market Trends

  • Increasing imports of innovative drugs from the US, EU, and China.
  • Growing use of biosimilars, with several launched since 2017.
  • Transition to value-based pricing models, focusing on drug effectiveness rather than volume.

Regulatory Framework Landscape

Key Regulatory Authorities

Authority Responsibilities Relevant Policies & Acts
Ministry of Food and Drug Safety (MFDS) Drug approvals, safety, and regulation Pharmaceutical Affairs Act (2010), Biological Products Act (2015)
Health Insurance Review & Assessment Service (HIRA) Reimbursement and pricing National Health Insurance Act

Approval Processes for Branded and Generic Drugs

Step Process Outline Typical Duration Key Considerations
New Drug Approval Clinical trials, NDA submission, review, approval 12-24 months Stringent clinical data requirements
Generic Drug Approval Bioequivalence studies, abbreviated new drug application (ANDA) 6-12 months Emphasis on demonstrating bioequivalence

Note: Introduction of accelerated review pathways for biologics and breakthrough therapies aims to reduce approval times (latest updates per 2022 regulations).

Pricing and Reimbursement Policies

  • The Korean National Health Insurance (NHI) negotiates drug prices.
  • The “Pricing and Reimbursement Schedule” prioritizes cost-effectiveness, with biosimilars receiving preferential review.
  • Price caps are imposed on generics to promote affordability.

Intellectual Property and Patent Regulations

  • Patent protections typically last 20 years from filing.
  • Follow WTO-TRIPS compliance, with some exceptions for public health emergencies.
  • Patent linkage is in effect, delaying generic entry post-patent expiry under certain conditions.

Opportunities for Market Entry and Expansion

Branded Drugs

Innovative Therapeutics Development:

  • Focus on biologics, immunotherapies, and niche indications.
  • Partnerships with domestic R&D centers to leverage government grants for innovation.

Regulatory Pathways:

  • Fast-track approvals available for breakthrough drugs.
  • Incentives for orphan drugs, including tax benefits and extended exclusivity.

Market Penetration Strategies:

  • Collaborations with local distributors.
  • Tailoring clinical trial strategies to meet regulatory standards.

Generic Drugs

Patent Expiry Opportunities:

  • Challenges with primary patents expiring in cardiovascular, metabolic, and infectious disease segments.
  • Cost advantages inherent in local manufacturing.

Regulatory Strategy:

  • Demonstrate bioequivalence efficiently via abbreviated pathways.
  • Utilize the existing domestic manufacturing infrastructure.

Market Growth Drivers:

  • Government policies targeting 30% generic market share by 2025.
  • Public and insurer pressure for lower drug prices.

Biosimilars:

  • Rapidly expanding segment with over 20 approved biosimilars since 2017.
  • Opportunities linked to biologic patent expirations, especially in oncology and rheumatoid arthritis.

Regulatory Challenges in South Korea

Complex and Evolving Approval Processes

  • Lengthy review cycles, especially for novel biologics.
  • High clinical trial standards requiring local data in some cases.

Pricing and Reimbursement Hurdles

  • Stringent negotiations prolong market access.
  • Preference for domestically developed drugs can hinder foreign competitors.

Intellectual Property and Patent Challenges

  • Risk of patent linkage delays.
  • Potential for patent challenge filings by local competitors.

Market-Specific Barriers

  • Language barriers and limited local clinical data requirements.
  • Cultural preferences for domestic brands influencing prescribing patterns.

Global Regulatory Divergence

  • Differences in regulatory standards compared with US FDA and EMA complicate global approvals.
  • Limited mutual recognition agreements.

Comparison with Regional Markets

Aspect South Korea Japan China India
Market Size (2022) USD 25 billion USD 42 billion USD 74 billion USD 42 billion
Regulatory Body MFDS PMDA NMPA CDSCO
Approval Speed 6-24 months 6-18 months 12-36 months 12-24 months
Reimbursement Policy Price negotiation, cost-effectiveness Price controls, reimbursement coverage Centralized negotiation, price caps Price controls, public funding
Biosimilar Adoption Rapid growth, ~20 approvals since 2017 Mature, expanding biologic market Emerging, early-stage adoption Growing, regulatory pathways emerging

Conclusion and Strategic Insights

South Korea’s pharmaceutical environment offers substantial market prospects due to its sizable domestic demand, innovation-driven pipeline, and government support for biosimilars and orphan drugs. However, success hinges on navigating a sophisticated regulatory process, understanding reimbursement intricacies, and aligning with local market preferences.

Key opportunities include:

  • Developing biologics and biosimilars, which align with government health priorities.
  • Enhancing local manufacturing capabilities to benefit from regional and domestic incentives.
  • Engaging early with MFDS to facilitate approval processes and leverage fast-track pathways.

Challenges to mitigate:

  • Lengthy approval timelines, particularly for innovative drugs.
  • Price negotiation pressures requiring strategic market access planning.
  • Protecting intellectual property amid patent challenges.

Key Takeaways

  • The South Korean pharmaceutical market is forecasted to sustain growth driven by aging demographics and innovation.
  • The branded segment remains dominant but faces pressure from generics and biosimilars.
  • Regulatory pathways for biologics and generics are well-established but require strategic navigation.
  • Price negotiations and reimbursement policies emphasize cost-effectiveness, underscoring the importance of demonstrating value.
  • Local partnerships and tailored clinical strategies improve market entry success.

FAQs

Q1: How long does it typically take for a new drug approval in South Korea?
A: Approximately 12 to 24 months, with accelerated pathways available for breakthrough therapies.

Q2: What are the key regulations impacting biosimilar approvals?
A: Demonstrating biosimilarity via rigorous comparability studies, adherence to MFDS guidelines, and strategic early engagement are crucial.

Q3: How does South Korea incentivize innovation in pharmaceuticals?
A: Through grants, tax benefits, extended exclusivity periods for orphan drugs, and fast-track review pathways.

Q4: What are the main barriers for foreign companies entering South Korea?
A: Lengthy approval processes, price negotiation challenges, language barriers, and local market preferences for domestic brands.

Q5: How does the patent landscape affect generic drug entry?
A: Patent protections last 20 years, but patent linkage and litigation can delay generic entry post-expiry, necessitating strategic patent analysis.


References

  1. Korea Pharmaceutical Industry Association (KPIA). (2022). “Korea Pharmaceutical Market Report.”
  2. Ministry of Food and Drug Safety (MFDS). (2022). “Regulatory Guidelines for Pharmaceuticals and Biologics.”
  3. National Health Insurance Service. (2022). “Pricing and Reimbursement Policies in South Korea.”
  4. World Trade Organization. (2022). “TRIPS Agreement: Pharmaceutical Patent Laws in South Korea.”
  5. IQVIA. (2022). “South Korea Pharmaceutical Market Dynamics.”

Note: Data and insights are up-to-date as of Q1 2023, reflecting recent policy reforms and market developments.

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