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Last Updated: March 24, 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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Hong Kong: These 24 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026

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Preferred citation:
Friedman, Yali, "Hong Kong: These 24 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 LO LOESTRIN FE (ethinyl estradiol; norethindrone acetate) generic drug versions launch?

Generic name: ethinyl estradiol; norethindrone acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 22, 2025
Generic Entry Controlled by: Hong Kong Patent 1,205,468
Patent Title: 延長的雌激素定量給藥避孕療法 (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN)

Drug Price Trends for LO LOESTRIN FE
LO LOESTRIN FE is a drug marketed by Apil. There is one patent protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has nine patent family members in seven countries. There has been litigation on patents covering LO LOESTRIN FE

See drug price trends for LO LOESTRIN FE.

The generic ingredient in LO LOESTRIN FE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this API. Twenty-six suppliers are listed for this generic product. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

When can LO MINASTRIN FE (ethinyl estradiol; norethindrone acetate) generic drug versions launch?

Generic name: ethinyl estradiol; norethindrone acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 22, 2025
Generic Entry Controlled by: Hong Kong Patent 1,205,468
Patent Title: 延長的雌激素定量給藥避孕療法 (EXTENDED ESTROGEN DOSING CONTRACEPTIVE REGIMEN)

LO MINASTRIN FE is a drug marketed by Apil. There is one patent protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has nine patent family members in seven countries. There has been litigation on patents covering LO MINASTRIN FE

The generic ingredient in LO MINASTRIN FE is ethinyl estradiol; norethindrone acetate. There are twenty-six drug master file entries for this API. Twenty-six suppliers are listed for this generic product. Additional details are available on the ethinyl estradiol; norethindrone acetate profile page.

When can BELEODAQ (belinostat) generic drug versions launch?

Generic name: belinostat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 13, 2025
Generic Entry Controlled by: Hong Kong Patent 1,110,797
Patent Title: PHARMACEUTICAL FORMULATIONS OF HDAC INHIBITORS

BELEODAQ is a drug marketed by Acrotech Biopharma. There are two patents protecting this drug and one Paragraph IV challenge.

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

See drug price trends for BELEODAQ.

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

When can XTANDI (enzalutamide) generic drug versions launch?

Generic name: enzalutamide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 13, 2025
Generic Entry Controlled by: Hong Kong Patent 1,112,856
Patent Title: DIARYLHYDANTOIN COMPOUND

XTANDI is a drug marketed by Astellas. There are five patents protecting this drug and one Paragraph IV challenge. Two tentatively approved generics are ready to enter the market.

This drug has one hundred and ninety patent family members in thirty-five countries. There has been litigation on patents covering XTANDI

See drug price trends for XTANDI.

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

When can XTANDI (enzalutamide) generic drug versions launch?

Generic name: enzalutamide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 13, 2025
Generic Entry Controlled by: Hong Kong Patent 1,124,612
Patent Title: 二芳基乙內酰硫脲化合物 (DIARYLTHIOHYDANTOIN COMPOUNDS)

XTANDI is a drug marketed by Astellas. There are five patents protecting this drug and one Paragraph IV challenge. Two tentatively approved generics are ready to enter the market.

This drug has one hundred and ninety patent family members in thirty-five countries. There has been litigation on patents covering XTANDI

See drug price trends for XTANDI.

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

When can XTANDI (enzalutamide) generic drug versions launch?

Generic name: enzalutamide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 13, 2025
Generic Entry Controlled by: Hong Kong Patent 1,169,321
Patent Title: 用於腫瘤治療作為雄激素受體拮抗劑的二芳基乙內酰脲化合物 (DIARYLHYDANTOIN COMPOUNDS AS ANDROGEN RECEPTOR ANTAGONISTS FOR TREATMENT OF CANCER)

XTANDI is a drug marketed by Astellas. There are five patents protecting this drug and one Paragraph IV challenge. Two tentatively approved generics are ready to enter the market.

This drug has one hundred and ninety patent family members in thirty-five countries. There has been litigation on patents covering XTANDI

See drug price trends for XTANDI.

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

When can XTANDI (enzalutamide) generic drug versions launch?

Generic name: enzalutamide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 13, 2025
Generic Entry Controlled by: Hong Kong Patent 1,177,691
Patent Title: 二芳基硫代乙內酰脲化合物 (DIARYLTHIOHYDANTOIN COMPOUNDS)

XTANDI is a drug marketed by Astellas. There are five patents protecting this drug and one Paragraph IV challenge. Two tentatively approved generics are ready to enter the market.

This drug has one hundred and ninety patent family members in thirty-five countries. There has been litigation on patents covering XTANDI

See drug price trends for XTANDI.

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

When can XTANDI (enzalutamide) generic drug versions launch?

Generic name: enzalutamide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 13, 2025
Generic Entry Controlled by: Hong Kong Patent 1,217,103
Patent Title: 二芳基乙內酰脲化合物 (DIARYLHYDANTOIN COMPOUNDS)

XTANDI is a drug marketed by Astellas. There are five patents protecting this drug and one Paragraph IV challenge. Two tentatively approved generics are ready to enter the market.

This drug has one hundred and ninety patent family members in thirty-five countries. There has been litigation on patents covering XTANDI

See drug price trends for XTANDI.

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

When can TRACLEER (bosentan) generic drug versions launch?

Generic name: bosentan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 17, 2025
Generic Entry Controlled by: Hong Kong Patent 1,120,212
Patent Title: DISPERSIBLE BOSERTAN TABLET

TRACLEER is a drug marketed by Actelion. There are two patents protecting this drug and one Paragraph IV challenge. Two tentatively approved generics are ready to enter the market.

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

See drug price trends for TRACLEER.

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

When can LATUDA (lurasidone hydrochloride) generic drug versions launch?

Generic name: lurasidone hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 26, 2025
Generic Entry Controlled by: Hong Kong Patent 1,108,379
Patent Title: PHARMACEUTICAL COMPOSITION COMPRISING LURASIDONE

Drug Price Trends for LATUDA
LATUDA is a drug marketed by Sunovion Pharms Inc. There are seven patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market.

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

See drug price trends for LATUDA.

The generic ingredient in LATUDA is lurasidone hydrochloride. There are twenty-six drug master file entries for this API. Twenty-nine suppliers are listed for this generic product. Additional details are available on the lurasidone hydrochloride profile page.

When can SPINRAZA (nusinersen sodium) generic drug versions launch?

Generic name: nusinersen sodium
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 23, 2025
Generic Entry Controlled by: Hong Kong Patent 1,181,307
Patent Title: 用於調節 剪接的組合物和方法 (COMPOSITIONS AND METHODS FOR MODULATION OF SMN2 SPLICING SMN2)

SPINRAZA is a drug marketed by Biogen Idec. There are nine patents protecting this drug.

This drug has one hundred and two patent family members in twenty-seven countries.

See drug price trends for SPINRAZA.

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

When can SPINRAZA (nusinersen sodium) generic drug versions launch?

Generic name: nusinersen sodium
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 23, 2025
Generic Entry Controlled by: Hong Kong Patent 1,247,103
Patent Title: 調節SMN2剪接的組合物和方法 (COMPOSITIONS AND METHODS FOR MODULATION OF SMN2 SPLICING)

SPINRAZA is a drug marketed by Biogen Idec. There are nine patents protecting this drug.

This drug has one hundred and two patent family members in twenty-seven countries.

See drug price trends for SPINRAZA.

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

When can APLENZIN (bupropion hydrobromide) generic drug versions launch?

Generic name: bupropion hydrobromide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 27, 2025
Generic Entry Controlled by: Hong Kong Patent 1,142,811

APLENZIN is a drug marketed by Bausch. There are eight patents protecting this drug and three Paragraph IV challenges. One tentatively approved generic is ready to enter the market.

This drug has fifty-two patent family members in eighteen countries.

See drug price trends for APLENZIN.

The generic ingredient in APLENZIN is bupropion hydrobromide. There are thirty-eight drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the bupropion hydrobromide profile page.

When can BOSULIF (bosutinib monohydrate) generic drug versions launch?

Generic name: bosutinib monohydrate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 01, 2025
Generic Entry Controlled by: Hong Kong Patent 1,114,614

BOSULIF is a drug marketed by Pf Prism Cv. There are four patents protecting this drug and two Paragraph IV challenges.

This drug has eighty-one patent family members in thirty countries. There has been litigation on patents covering BOSULIF

See drug price trends for BOSULIF.

The generic ingredient in BOSULIF is bosutinib monohydrate. There are five drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the bosutinib monohydrate profile page.

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

Generic name: simeprevir sodium
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 29, 2025
Generic Entry Controlled by: Hong Kong Patent 1,116,771
Patent Title: MACROCYCLIC 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 OLYSIO (simeprevir sodium) generic drug versions launch?

Generic name: simeprevir sodium
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 29, 2025
Generic Entry Controlled by: Hong Kong Patent 1,183,872
Patent Title: 丙型肝炎病毒的大環抑制劑 (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 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, 2025
Generic Entry Controlled by: Hong Kong Patent 1,119,559
Patent Title: PANCREATIN MICROPELLET CORES SUITABLE FOR ENTERIC COATING

CREON is a drug marketed by

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

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. 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, 2025
Generic Entry Controlled by: Hong Kong Patent 1,121,037
Patent Title: 酸不穩定性藥物的控釋藥物組合物 (CONTROLLED RELEASE PHARMACEUTICAL COMPOSITIONS FOR ACID LABILE DRUGS)

CREON is a drug marketed by

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

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. Additional details are available on the pancrelipase (amylase;lipase;protease) profile page.

When can JYNARQUE (tolvaptan) generic drug versions launch?

Generic name: tolvaptan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 02, 2025
Generic Entry Controlled by: Hong Kong Patent 1,124,318
Patent Title: PROCESS FOR PREPARING BENZAZEPINE COMPOUNDS OR SALTS THEREOF

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. Six 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 02, 2025
Generic Entry Controlled by: Hong Kong Patent 1,144,932
Patent Title: PROCESS FOR PREPARING DERIVATIVES OF BENZOIC ACID

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. Six 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 02, 2025
Generic Entry Controlled by: Hong Kong Patent 1,145,835
Patent Title: 製備苯並氮雜卓化合物或其鹽的方法 (PROCESS FOR PREPARING BENZAZEPINE COMPOUNDS OR SALTS THEREOF)

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. Six 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 02, 2025
Generic Entry Controlled by: Hong Kong Patent 1,148,999
Patent Title: THE PROCESS FOR PREPARING BENZAZEPINE COMPOUNDS OR SALTS THEREOF

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. Six 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 02, 2025
Generic Entry Controlled by: Hong Kong Patent 1,172,329
Patent Title: 製備苯並氮雜䓬化合物或其鹽的方法 (PROCESS FOR PREPARING BENZAZEPINE COMPOUNDS OR SALTS THEREOF)

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. Six 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 02, 2025
Generic Entry Controlled by: Hong Kong Patent 1,124,318
Patent Title: PROCESS FOR PREPARING BENZAZEPINE COMPOUNDS OR SALTS THEREOF

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. Six 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 02, 2025
Generic Entry Controlled by: Hong Kong Patent 1,144,932
Patent Title: PROCESS FOR PREPARING DERIVATIVES OF BENZOIC ACID

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. Six 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 02, 2025
Generic Entry Controlled by: Hong Kong Patent 1,145,835
Patent Title: 製備苯並氮雜卓化合物或其鹽的方法 (PROCESS FOR PREPARING BENZAZEPINE COMPOUNDS OR SALTS THEREOF)

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. Six 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 02, 2025
Generic Entry Controlled by: Hong Kong Patent 1,148,999
Patent Title: THE PROCESS FOR PREPARING BENZAZEPINE COMPOUNDS OR SALTS THEREOF

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. Six 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 02, 2025
Generic Entry Controlled by: Hong Kong Patent 1,172,329
Patent Title: 製備苯並氮雜䓬化合物或其鹽的方法 (PROCESS FOR PREPARING BENZAZEPINE COMPOUNDS OR SALTS THEREOF)

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. Six 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, 2025
Generic Entry Controlled by: Hong Kong Patent 1,117,762
Patent Title: 吡非尼酮與藥學上可接受的賦形劑的膠囊製劑 (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-four 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-two suppliers are listed for this generic product. Additional details are available on the pirfenidone profile page.

When can LYRICA CR (pregabalin) generic drug versions launch?

Generic name: pregabalin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 02, 2025
Generic Entry Controlled by: Hong Kong Patent 1,126,394
Patent Title: SOLID ORAL PHARMACEUTICAL COMPOSITIONS FOR ONCE DAILY DOSING CONTAINING PREGABALIN, A MATRIX FORMING AGENT AND A SWELLING AGENT

Drug Price Trends for LYRICA CR
LYRICA CR is a drug marketed by Upjohn. There are three patents protecting this drug and four Paragraph IV challenges. Six tentatively approved generics are ready to enter the market.

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

See drug price trends for LYRICA CR.

The generic ingredient in LYRICA CR is pregabalin. There are forty-one drug master file entries for this API. Fifty-six suppliers are listed for this generic product. Additional details are available on the pregabalin 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 09, 2025
Generic Entry Controlled by: Hong Kong Patent 1,121,371
Patent Title: PHARMACEUTICAL COMBINATIONS OF AN ANGIOTENSIN RECEPTOR ANTAGONIST AND AN NEP INHIBITOR

ENTRESTO SPRINKLE is a drug marketed by Novartis. There are four patents protecting this drug.

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

The generic ingredient in ENTRESTO SPRINKLE is sacubitril; valsartan. There are eleven drug master file entries for this API. Nine 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 09, 2025
Generic Entry Controlled by: Hong Kong Patent 1,175,465
Patent Title: 血管緊張素受體拮抗劑和 抑制劑的藥物組合產品 (PHARMACEUTICAL COMBINATIONS OF AN ANGIOTENSIN RECEPTOR ANTAGONIST AND AN NEP INHIBITOR NEP)

ENTRESTO SPRINKLE is a drug marketed by Novartis. There are four patents protecting this drug.

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

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

When can XALKORI (crizotinib) generic drug versions launch?

Generic name: crizotinib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 05, 2025
Generic Entry Controlled by: Hong Kong Patent 1,126,477
Patent Title: POLYMORPHS OF A C-MET/HGFR INHIBITOR C-MET/HGFR

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 KOSELUGO (selumetinib sulfate) generic drug versions launch?

Generic name: selumetinib sulfate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 21, 2025
Generic Entry Controlled by: Hong Kong Patent 1,124,043
Patent Title: NOVEL HYDROGEN SULFATE SALT

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

This drug has one hundred and ninety-eight patent family members in forty-four countries.

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 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: Hong Kong Patent 1,126,975
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: Hong Kong Patent 1,127,358
Patent Title: 製備種 型腺苷受體激動劑及其多晶形物的方法 (PROCESS FOR PREPARING AN A2A-ADENOSINE RECEPTOR AGONIST AND ITS POLYMORPHS A2A)

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. Fifteen 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: Hong Kong Patent 1,212,250
Patent Title: 抗病毒化合物、包含該化合物的劑型及其用途 (ANTIVIRAL COMPOUNDS, UNIT DOSAGE FORM COMPRISING SAID COMPOUNDS AND USE THEREOF)

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

This drug has forty-two 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 PRESTALIA (amlodipine besylate; perindopril arginine) generic drug versions launch?

Generic name: amlodipine besylate; perindopril arginine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 28, 2026
Generic Entry Controlled by: Hong Kong Patent 1,129,669

PRESTALIA is a drug marketed by Adhera. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has thirty patent family members in twenty-seven countries. There has been litigation on patents covering PRESTALIA

The generic ingredient in PRESTALIA is amlodipine besylate; perindopril arginine. There are fifty drug master file entries for this API. Additional details are available on the amlodipine besylate; perindopril arginine 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: Hong Kong Patent 1,131,331
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 TRADJENTA (linagliptin) generic drug versions launch?

Generic name: linagliptin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 04, 2026
Generic Entry Controlled by: Hong Kong Patent 1,130,442

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

This drug has four hundred and sixty-two 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: Hong Kong Patent 1,172,549

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

This drug has four hundred and sixty-two 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.

Market Analysis and Financial Projection

Hong Kong's pharmaceutical market is undergoing significant transformation, balancing between established branded drug sectors and growing generic opportunities amidst evolving regulatory reforms. The Hospital Authority's dominant role in public healthcare (serving 90% of the population) and recent policy shifts create both opportunities and challenges for stakeholders.

Market Overview

  • Branded Drugs: The Hospital Authority's (HA) formulary listing delays and preference for bulk purchasing of generics have constrained multinational pharmaceutical companies, though the new 1+ approval system (cutting registration timelines from 24 to 7 months) offers faster market entry[1][6].
  • Generics: A $365.7M OTC market by 2030[2] and HA's procurement policies (90% generic use in public hospitals) drive demand, yet public skepticism persists—40% of healthcare professionals question generic quality[9][13].

Regulatory Opportunities

  • Accelerated Approvals: The 1+ system accepts documentation from 36 reference agencies (e.g., U.S. FDA), streamlining registration for branded drugs[1]. Generics benefit from HA’s 2016 PIC/S membership, allowing imports from trusted manufacturing regions[13].
  • Clinical Trial Hub Potential: Plans for a standalone drug authority by 2033–2035 aim to position Hong Kong as a regional hub, leveraging its gateway status to China[1][5].
  • Harmonization with China: Cross-border regulatory alignment discussions could enable mutual recognition of clinical trials, though IP protection remains a hurdle[5][8].

Key Challenges

  • Branded Drug Barriers:
    • HA’s formulary delays (6–24 months)[6] and preference for generics[9].
    • Limited reimbursement pathways and price pressures in public procurement[4][8].
  • Generic Market Hurdles:
    • Bioequivalence Requirements: Mandatory pharmacokinetic data for antiepileptics and narrow-therapeutic-index drugs increase compliance costs[9][10].
    • Public Perception: 60% of patients demand consent for generic substitution, while 70% of doctors associate lower cost with lower quality[9][11].

Regulatory Landscape Analysis

Aspect Branded Drugs Generics
Registration Timeline 7 months under 1+ system[1] 12+ months with bioequivalence studies[10]
Market Access HA formulary delays hinder uptake[6] HA bulk contracts drive volume[13]
IP & Pricing Weak IP enforcement during tech transfers[8] Price erosion due to tendering[13]

Strategic Outlook:
Hong Kong’s push for regulatory modernization (e.g., 1+ system, PIC/S alignment) positions it as a testing ground for regional expansion[1][13]. However, overcoming brand loyalty and streamlining cross-border IP frameworks will be critical. For generics, expanding bioequivalence mandates and public education could accelerate adoption, while branded drugs require advocacy for equitable formulary access[9][12].

"The 1+ system marks a paradigm shift, reducing bureaucratic inertia and fostering innovation." – Trade.gov Hong Kong Healthcare Report[1]

Sources: [1][2][4][5][6][8][9][10][13]

References

  1. https://www.trade.gov/market-intelligence/hong-kong-healthcare-drug-system
  2. https://www.insights10.com/report/hong-kong-over-the-counter-otc-pharmaceuticals-market-analysis/
  3. https://www.ppbhk.org.hk/eng/files/Report_of_Review_Committee_eng.pdf
  4. https://www.ijdra.com/index.php/journal/article/download/575/319
  5. https://2013.icpoep.com/documents/conference-2013/Pharmaceutical%20Development%20in%20Hong%20Kong%20-%20Prospects%20and%20Challenges.pdf
  6. https://pmc.ncbi.nlm.nih.gov/articles/PMC3555014/
  7. https://www.insights10.com/report/hong-kong-pharmaceutical-market-analysis/
  8. https://www.morganlewis.com/pubs/2024/09/china-boosts-regulatory-framework-for-local-pharmaceutical-manufacturing
  9. https://www.hkmj.org/abstracts/v24n6/554.htm
  10. https://www.artixio.com/post/hong-kong-new-drugs-generics-biosimilar-regulations
  11. https://pdfs.semanticscholar.org/38d5/2ba979461f4a637bdb0be9319f99dba862b0.pdf
  12. https://papers.ssrn.com/sol3/Delivery.cfm/SSRN_ID2434953_code838877.pdf?abstractid=2434953&mirid=1
  13. https://ihe.se/app/uploads/2021/11/IHE-Report-2021_3g_.pdf

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