Last Updated: May 11, 2026

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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Denmark: These 51 Drugs Face Patent Expirations and Generic Entry From 2026 - 2027

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Preferred citation:
Friedman, Yali, "Denmark: These 51 Drugs Face Patent Expirations and Generic Entry From 2026 - 2027" DrugPatentWatch.com thinkBiotech, 2026 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 VANTRELA ER (hydrocodone bitartrate) generic drug versions launch?

Generic name: hydrocodone bitartrate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 15, 2026
Generic Entry Controlled by: Denmark Patent 2,073,795

VANTRELA ER is a drug marketed by Teva Branded Pharm. There are three patents protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has thirty-three patent family members in thirteen countries. There has been litigation on patents covering VANTRELA ER

The generic ingredient in VANTRELA ER is hydrocodone bitartrate. There are twenty-three drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the hydrocodone bitartrate profile page.

When can VANTRELA ER (hydrocodone bitartrate) generic drug versions launch?

Generic name: hydrocodone bitartrate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 15, 2026
Generic Entry Controlled by: Denmark Patent 2,200,593

VANTRELA ER is a drug marketed by Teva Branded Pharm. There are three patents protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has thirty-three patent family members in thirteen countries. There has been litigation on patents covering VANTRELA ER

The generic ingredient in VANTRELA ER is hydrocodone bitartrate. There are twenty-three drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the hydrocodone bitartrate profile page.

When can VANTRELA ER (hydrocodone bitartrate) generic drug versions launch?

Generic name: hydrocodone bitartrate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 15, 2026
Generic Entry Controlled by: Denmark Patent 2,692,341

VANTRELA ER is a drug marketed by Teva Branded Pharm. There are three patents protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has thirty-three patent family members in thirteen countries. There has been litigation on patents covering VANTRELA ER

The generic ingredient in VANTRELA ER is hydrocodone bitartrate. There are twenty-three drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the hydrocodone bitartrate 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: Denmark Patent 2,142,193

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. Three 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: Denmark Patent 2,034,975

EMBEDA is a drug marketed by Alpharma Pharms. There are seven 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 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: Denmark Patent 2,526,932

EMBEDA is a drug marketed by Alpharma Pharms. There are seven 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 XADAGO (safinamide mesylate) generic drug versions launch?

Generic name: safinamide mesylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2026
Generic Entry Controlled by: Denmark Patent 2,029,524

Drug Price Trends for XADAGO
XADAGO is a drug marketed by Mdd Us. There are three patents protecting this drug.

This drug has ninety-seven patent family members in thirty-one countries. There has been litigation on patents covering XADAGO

See drug price trends for XADAGO.

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

When can XADAGO (safinamide mesylate) generic drug versions launch?

Generic name: safinamide mesylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2026
Generic Entry Controlled by: Denmark Patent 2,474,521

Drug Price Trends for XADAGO
XADAGO is a drug marketed by Mdd Us. There are three patents protecting this drug.

This drug has ninety-seven patent family members in thirty-one countries. There has been litigation on patents covering XADAGO

See drug price trends for XADAGO.

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

When can JESDUVROQ (daprodustat) generic drug versions launch?

Generic name: daprodustat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 23, 2026
Generic Entry Controlled by: Denmark Patent 2,037,922

JESDUVROQ is a drug marketed by Glaxosmithkline. There are six patents protecting this drug.

This drug has forty-four patent family members in thirty-one countries.

See drug price trends for JESDUVROQ.

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

When can BYDUREON (exenatide synthetic) generic drug versions launch?

Generic name: exenatide synthetic
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Denmark Patent 2,069,374

Drug Price Trends for BYDUREON
BYDUREON is a drug marketed by Astrazeneca Ab. There are seven patents protecting this drug.

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

See drug price trends for BYDUREON.

The generic ingredient in BYDUREON is exenatide synthetic. There are seven drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the exenatide synthetic profile page.

When can FARXIGA (dapagliflozin) generic drug versions launch?

Generic name: dapagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Denmark Patent 2,069,374

Drug Price Trends for FARXIGA
FARXIGA is a drug marketed by Astrazeneca Ab. There are seventeen patents protecting this drug and one Paragraph IV challenge. Thirteen tentatively approved generics are ready to enter the market.

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

See drug price trends for FARXIGA.

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

When can QTERN (dapagliflozin; saxagliptin hydrochloride) generic drug versions launch?

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Denmark Patent 2,069,374

Drug Price Trends for QTERN
QTERN is a drug marketed by Astrazeneca Ab. There are seven patents protecting this drug and one Paragraph IV challenge.

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

See drug price trends for QTERN.

The generic ingredient in QTERN is dapagliflozin; saxagliptin hydrochloride. There are twenty-six drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the dapagliflozin; saxagliptin hydrochloride profile page.

When can EVOTAZ (atazanavir sulfate; cobicistat) generic drug versions launch?

Generic name: atazanavir sulfate; cobicistat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 07, 2026
Generic Entry Controlled by: Denmark Patent 2,049,506

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

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

See drug price trends for EVOTAZ.

The generic ingredient in EVOTAZ is atazanavir sulfate; cobicistat. There are twenty-five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the atazanavir sulfate; cobicistat profile page.

When can EVOTAZ (atazanavir sulfate; cobicistat) generic drug versions launch?

Generic name: atazanavir sulfate; cobicistat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 07, 2026
Generic Entry Controlled by: Denmark Patent 2,487,161

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

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

See drug price trends for EVOTAZ.

The generic ingredient in EVOTAZ is atazanavir sulfate; cobicistat. There are twenty-five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the atazanavir sulfate; cobicistat profile page.

When can EVOTAZ (atazanavir sulfate; cobicistat) generic drug versions launch?

Generic name: atazanavir sulfate; cobicistat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 07, 2026
Generic Entry Controlled by: Denmark Patent 2,487,163

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

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

See drug price trends for EVOTAZ.

The generic ingredient in EVOTAZ is atazanavir sulfate; cobicistat. There are twenty-five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the atazanavir sulfate; cobicistat profile page.

When can EVOTAZ (atazanavir sulfate; cobicistat) generic drug versions launch?

Generic name: atazanavir sulfate; cobicistat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 07, 2026
Generic Entry Controlled by: Denmark Patent 2,487,166

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

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

See drug price trends for EVOTAZ.

The generic ingredient in EVOTAZ is atazanavir sulfate; cobicistat. There are twenty-five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the atazanavir sulfate; cobicistat profile page.

When can EVOTAZ (atazanavir sulfate; cobicistat) generic drug versions launch?

Generic name: atazanavir sulfate; cobicistat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 07, 2026
Generic Entry Controlled by: Denmark Patent 3,150,586

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

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

See drug price trends for EVOTAZ.

The generic ingredient in EVOTAZ is atazanavir sulfate; cobicistat. There are twenty-five drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the atazanavir sulfate; cobicistat profile page.

When can BYFAVO (remimazolam besylate) generic drug versions launch?

Generic name: remimazolam besylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 10, 2026
Generic Entry Controlled by: Denmark Patent 2,081,921

BYFAVO is a drug marketed by Acacia. There are eleven patents protecting this drug.

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

See drug price trends for BYFAVO.

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

When can REZDIFFRA (resmetirom) generic drug versions launch?

Generic name: resmetirom
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 11, 2026
Generic Entry Controlled by: Denmark Patent 1,919,878

REZDIFFRA is a drug marketed by Madrigal. There are six patents protecting this drug.

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

See drug price trends for REZDIFFRA.

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

When can EPIDUO (adapalene; benzoyl peroxide) generic drug versions launch?

Generic name: adapalene; benzoyl peroxide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 13, 2026
Generic Entry Controlled by: Denmark Patent 2,046,318

Drug Price Trends for EPIDUO
EPIDUO is a drug marketed by Galderma Labs Lp and Galderma LabsThere are three patents protecting this drug and two Paragraph IV challenges.

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

See drug price trends for EPIDUO.

The generic ingredient in EPIDUO is adapalene; benzoyl peroxide. There are twelve drug master file entries for this API. Twelve suppliers are listed for this generic product. Additional details are available on the adapalene; benzoyl peroxide profile page.

When can EPIDUO (adapalene; benzoyl peroxide) generic drug versions launch?

Generic name: adapalene; benzoyl peroxide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 13, 2026
Generic Entry Controlled by: Denmark Patent 2,450,035

Drug Price Trends for EPIDUO
EPIDUO is a drug marketed by Galderma Labs Lp and Galderma LabsThere are three patents protecting this drug and two Paragraph IV challenges.

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

See drug price trends for EPIDUO.

The generic ingredient in EPIDUO is adapalene; benzoyl peroxide. There are twelve drug master file entries for this API. Twelve suppliers are listed for this generic product. Additional details are available on the adapalene; benzoyl peroxide profile page.

When can EPIDUO FORTE (adapalene; benzoyl peroxide) generic drug versions launch?

Generic name: adapalene; benzoyl peroxide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 13, 2026
Generic Entry Controlled by: Denmark Patent 2,046,318

Drug Price Trends for EPIDUO FORTE
EPIDUO FORTE is a drug marketed by Galderma Labs.

This drug has thirty-five patent family members in twenty-two countries. There has been litigation on patents covering EPIDUO FORTE

See drug price trends for EPIDUO FORTE.

The generic ingredient in EPIDUO FORTE is adapalene; benzoyl peroxide. There are twelve drug master file entries for this API. Twelve suppliers are listed for this generic product. Additional details are available on the adapalene; benzoyl peroxide profile page.

When can EPIDUO FORTE (adapalene; benzoyl peroxide) generic drug versions launch?

Generic name: adapalene; benzoyl peroxide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 13, 2026
Generic Entry Controlled by: Denmark Patent 2,450,035

Drug Price Trends for EPIDUO FORTE
EPIDUO FORTE is a drug marketed by Galderma Labs.

This drug has thirty-five patent family members in twenty-two countries. There has been litigation on patents covering EPIDUO FORTE

See drug price trends for EPIDUO FORTE.

The generic ingredient in EPIDUO FORTE is adapalene; benzoyl peroxide. There are twelve drug master file entries for this API. Twelve suppliers are listed for this generic product. Additional details are available on the adapalene; benzoyl peroxide profile page.

When can RASUVO (methotrexate) generic drug versions launch?

Generic name: methotrexate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 21, 2026
Generic Entry Controlled by: Denmark Patent 2,046,332

Drug Price Trends for RASUVO
RASUVO is a drug marketed by Medexus. There is one patent protecting this drug.

This drug has twenty-nine patent family members in twenty-one countries. There has been litigation on patents covering RASUVO

See drug price trends for RASUVO.

The generic ingredient in RASUVO is methotrexate. There are twenty drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the methotrexate 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: Denmark Patent 1,912,999

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

This drug has sixty-four patent family members in forty-one 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 DAKLINZA (daclatasvir dihydrochloride) generic drug versions launch?

Generic name: daclatasvir dihydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 11, 2026
Generic Entry Controlled by: Denmark Patent 2,049,522

Drug Price Trends for DAKLINZA
DAKLINZA is a drug marketed by Bristol-myers Squibb. There are five patents protecting this drug.

This drug has ninety-three patent family members in thirty-one countries. There has been litigation on patents covering DAKLINZA

See drug price trends for DAKLINZA.

The generic ingredient in DAKLINZA is daclatasvir dihydrochloride. There are five drug master file entries for this API. Additional details are available on the daclatasvir dihydrochloride profile page.

When can DAKLINZA (daclatasvir dihydrochloride) generic drug versions launch?

Generic name: daclatasvir dihydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 11, 2026
Generic Entry Controlled by: Denmark Patent 2,784,075

Drug Price Trends for DAKLINZA
DAKLINZA is a drug marketed by Bristol-myers Squibb. There are five patents protecting this drug.

This drug has ninety-three patent family members in thirty-one countries. There has been litigation on patents covering DAKLINZA

See drug price trends for DAKLINZA.

The generic ingredient in DAKLINZA is daclatasvir dihydrochloride. There are five drug master file entries for this API. Additional details are available on the daclatasvir dihydrochloride profile page.

When can DAKLINZA (daclatasvir dihydrochloride) generic drug versions launch?

Generic name: daclatasvir dihydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 11, 2026
Generic Entry Controlled by: Denmark Patent 3,042,901

Drug Price Trends for DAKLINZA
DAKLINZA is a drug marketed by Bristol-myers Squibb. There are five patents protecting this drug.

This drug has ninety-three patent family members in thirty-one countries. There has been litigation on patents covering DAKLINZA

See drug price trends for DAKLINZA.

The generic ingredient in DAKLINZA is daclatasvir dihydrochloride. There are five drug master file entries for this API. Additional details are available on the daclatasvir dihydrochloride 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: Denmark Patent 1,931,316

CREON is a drug marketed by

This drug has ninety-three patent family members in thirty-one 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. 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: Denmark Patent 2,056,832

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

This drug has sixty-two patent family members in thirty-five 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-six suppliers are listed for this generic product. Additional details are available on the ticagrelor profile page.

When can OPSUMIT (macitentan) generic drug versions launch?

Generic name: macitentan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 29, 2026
Generic Entry Controlled by: Denmark Patent 2,059,246

OPSUMIT is a drug marketed by Actelion. There are five patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market.

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

See drug price trends for OPSUMIT.

The generic ingredient in OPSUMIT is macitentan. There are ten drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the macitentan 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: Denmark Patent 1,919,874

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: Denmark Patent 1,919,874

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: Denmark Patent 1,940,364

ESBRIET is a drug marketed by Legacy Pharma. 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 ZUNVEYL (benzgalantamine gluconate) generic drug versions launch?

Generic name: benzgalantamine gluconate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: September 22, 2026
Generic Entry Controlled by: Denmark Patent 1,940,817

ZUNVEYL is a drug marketed by Alpha Cognition. There are four patents protecting this drug.

This drug has twenty-six patent family members in seventeen countries. There has been litigation on patents covering ZUNVEYL

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

When can TYMLOS (abaloparatide) generic drug versions launch?

Generic name: abaloparatide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 03, 2026
Generic Entry Controlled by: Denmark Patent 2,957,278

Drug Price Trends for TYMLOS
TYMLOS is a drug marketed by Radius. There are nine patents protecting this drug.

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

See drug price trends for TYMLOS.

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

When can INREBIC (fedratinib hydrochloride) generic drug versions launch?

Generic name: fedratinib hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 26, 2026
Generic Entry Controlled by: Denmark Patent 1,951,684

INREBIC is a drug marketed by Bristol-myers. There are five patents protecting this drug.

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

See drug price trends for INREBIC.

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

When can BEVYXXA (betrixaban) generic drug versions launch?

Generic name: betrixaban
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 07, 2026
Generic Entry Controlled by: Denmark Patent 1,948,608

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 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: Denmark Patent 2,340,828

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

This drug has one hundred and eight patent family members in thirty-nine 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-four suppliers are listed for this generic product. Additional details are available on the sacubitril; valsartan profile page.

When can ZUBSOLV (buprenorphine hydrochloride; naloxone hydrochloride) generic drug versions launch?

Generic name: buprenorphine hydrochloride; naloxone hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 04, 2026
Generic Entry Controlled by: Denmark Patent 2,101,740

Drug Price Trends for ZUBSOLV
ZUBSOLV is a drug marketed by Edenbridge Pharms. There are ten patents protecting this drug and four Paragraph IV challenges. Two tentatively approved generics are ready to enter the market.

This drug has sixty-two patent family members in thirty-two countries. There has been litigation on patents covering ZUBSOLV

See drug price trends for ZUBSOLV.

The generic ingredient in ZUBSOLV is buprenorphine hydrochloride; naloxone hydrochloride. There are twenty-nine drug master file entries for this API. Twenty-seven suppliers are listed for this generic product. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.

When can SIRTURO (bedaquiline fumarate) generic drug versions launch?

Generic name: bedaquiline fumarate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 05, 2026
Generic Entry Controlled by: Denmark Patent 2,086,940

SIRTURO is a drug marketed by Janssen Therap. There are two patents protecting this drug.

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

See drug price trends for SIRTURO.

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

When can ZYKADIA (ceritinib) generic drug versions launch?

Generic name: ceritinib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 08, 2026
Generic Entry Controlled by: Denmark Patent 2,091,918

ZYKADIA is a drug marketed by Novartis. There are eight patents protecting this drug.

This drug has three hundred and twenty-two patent family members in fifty-six countries.

See drug price trends for ZYKADIA.

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

When can LETAIRIS (ambrisentan) generic drug versions launch?

Generic name: ambrisentan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 12, 2026
Generic Entry Controlled by: Denmark Patent 2,101,777

LETAIRIS is a drug marketed by Gilead. There are three patents protecting this drug and one Paragraph IV challenge.

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

See drug price trends for LETAIRIS.

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

When can XERMELO (telotristat etiprate) generic drug versions launch?

Generic name: telotristat etiprate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 12, 2026
Generic Entry Controlled by: Denmark Patent 2,091,940

XERMELO is a drug marketed by Tersera. There are five patents protecting this drug.

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

See drug price trends for XERMELO.

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

When can XERMELO (telotristat etiprate) generic drug versions launch?

Generic name: telotristat etiprate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 12, 2026
Generic Entry Controlled by: Denmark Patent 3,176,159

XERMELO is a drug marketed by Tersera. There are five patents protecting this drug.

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

See drug price trends for XERMELO.

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

When can VYKAT XR (diazoxide choline) generic drug versions launch?

Generic name: diazoxide choline
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 20, 2026
Generic Entry Controlled by: Denmark Patent 1,968,601

VYKAT XR is a drug marketed by Soleno Therap. There are six patents protecting this drug.

This drug has seventy-eight patent family members in twenty-two countries.

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

When can OSENI (alogliptin benzoate; pioglitazone hydrochloride) generic drug versions launch?

Generic name: alogliptin benzoate; pioglitazone hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 01, 2027
Generic Entry Controlled by: Denmark Patent 2,107,905

Drug Price Trends for OSENI
OSENI is a drug marketed by Takeda Pharms Usa. There are two patents protecting this drug.

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

See drug price trends for OSENI.

The generic ingredient in OSENI is alogliptin benzoate; pioglitazone hydrochloride. There are ten drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the alogliptin benzoate; pioglitazone hydrochloride profile page.

When can MACRILEN (macimorelin acetate) generic drug versions launch?

Generic name: macimorelin acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 19, 2027
Generic Entry Controlled by: Denmark Patent 1,984,744

MACRILEN is a drug marketed by Aeterna Zentaris. There is one patent protecting this drug.

This drug has eleven patent family members in ten countries.

See drug price trends for MACRILEN.

The generic ingredient in MACRILEN is macimorelin acetate. Two suppliers are listed for this generic product. Additional details are available on the macimorelin acetate profile page.

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

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 20, 2027
Generic Entry Controlled by: Denmark Patent 2,079,445

PANCREAZE is a drug marketed by

This drug has eleven patent family members in ten countries.

See drug price trends for PANCREAZE.

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

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

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 20, 2027
Generic Entry Controlled by: Denmark Patent 2,079,445

ZENPEP is a drug marketed by

This drug has eleven patent family members in ten countries.

See drug price trends for ZENPEP.

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

When can XENLETA (lefamulin acetate) generic drug versions launch?

Generic name: lefamulin acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 20, 2027
Generic Entry Controlled by: Denmark Patent 2,137,143

XENLETA is a drug marketed by Hong Kong. There are four patents protecting this drug.

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

See drug price trends for XENLETA.

The generic ingredient in XENLETA is lefamulin acetate. Additional details are available on the lefamulin acetate profile page.

When can XENLETA (lefamulin acetate) generic drug versions launch?

Generic name: lefamulin acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 20, 2027
Generic Entry Controlled by: Denmark Patent 2,380,874

XENLETA is a drug marketed by Hong Kong. There are four patents protecting this drug.

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

See drug price trends for XENLETA.

The generic ingredient in XENLETA is lefamulin acetate. Additional details are available on the lefamulin acetate profile page.

When can SYMDEKO (COPACKAGED) (ivacaftor; ivacaftor, tezacaftor) generic drug versions launch?

Generic name: ivacaftor; ivacaftor, tezacaftor
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 09, 2027
Generic Entry Controlled by: Denmark Patent 2,007,756

SYMDEKO (COPACKAGED) is a drug marketed by Vertex Pharms Inc. There are twenty-six patents protecting this drug.

This drug has four hundred and twenty-eight patent family members in forty-one countries. There has been litigation on patents covering SYMDEKO (COPACKAGED)

The generic ingredient in SYMDEKO (COPACKAGED) is ivacaftor; ivacaftor, tezacaftor. There are three drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the ivacaftor; ivacaftor, tezacaftor profile page.

When can SYMDEKO (COPACKAGED) (ivacaftor; ivacaftor, tezacaftor) generic drug versions launch?

Generic name: ivacaftor; ivacaftor, tezacaftor
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 09, 2027
Generic Entry Controlled by: Denmark Patent 2,674,428

SYMDEKO (COPACKAGED) is a drug marketed by Vertex Pharms Inc. There are twenty-six patents protecting this drug.

This drug has four hundred and twenty-eight patent family members in forty-one countries. There has been litigation on patents covering SYMDEKO (COPACKAGED)

The generic ingredient in SYMDEKO (COPACKAGED) is ivacaftor; ivacaftor, tezacaftor. There are three drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the ivacaftor; ivacaftor, tezacaftor profile page.

When can SYMDEKO (COPACKAGED) (ivacaftor; ivacaftor, tezacaftor) generic drug versions launch?

Generic name: ivacaftor; ivacaftor, tezacaftor
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 09, 2027
Generic Entry Controlled by: Denmark Patent 3,091,011

SYMDEKO (COPACKAGED) is a drug marketed by Vertex Pharms Inc. There are twenty-six patents protecting this drug.

This drug has four hundred and twenty-eight patent family members in forty-one countries. There has been litigation on patents covering SYMDEKO (COPACKAGED)

The generic ingredient in SYMDEKO (COPACKAGED) is ivacaftor; ivacaftor, tezacaftor. There are three drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the ivacaftor; ivacaftor, tezacaftor profile page.

When can QVAR REDIHALER (beclomethasone dipropionate) generic drug versions launch?

Generic name: beclomethasone dipropionate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 11, 2027
Generic Entry Controlled by: Denmark Patent 2,135,199

Drug Price Trends for QVAR REDIHALER
QVAR REDIHALER is a drug marketed by Norton Waterford. There are seventeen patents protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has two hundred and seventy-eight patent family members in twenty-seven countries. There has been litigation on patents covering QVAR REDIHALER

See drug price trends for QVAR REDIHALER.

The generic ingredient in QVAR REDIHALER is beclomethasone dipropionate. There are twenty drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the beclomethasone dipropionate profile page.

When can TRADJENTA (linagliptin) generic drug versions launch?

Generic name: linagliptin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: April 30, 2027
Generic Entry Controlled by: Denmark Patent 2,023,902

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. Three tentatively approved generics are ready to enter the market.

This drug has three hundred and eighty-one patent family members in forty-one 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 PROMACTA (eltrombopag olamine) generic drug versions launch?

Generic name: eltrombopag olamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 03, 2027
Generic Entry Controlled by: Denmark Patent 2,152,237

PROMACTA is a drug marketed by Novartis. There are six patents protecting this drug and two Paragraph IV challenges.

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

See drug price trends for PROMACTA.

The generic ingredient in PROMACTA is eltrombopag olamine. There are three drug master file entries for this API. Eleven suppliers are listed for this generic product. Additional details are available on the eltrombopag olamine profile page.

When can PROMACTA (eltrombopag olamine) generic drug versions launch?

Generic name: eltrombopag olamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 03, 2027
Generic Entry Controlled by: Denmark Patent 4,218,732

PROMACTA is a drug marketed by Novartis. There are six patents protecting this drug and two Paragraph IV challenges.

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

See drug price trends for PROMACTA.

The generic ingredient in PROMACTA is eltrombopag olamine. There are three drug master file entries for this API. Eleven suppliers are listed for this generic product. Additional details are available on the eltrombopag olamine profile page.

When can SIGNIFOR LAR (pasireotide pamoate) generic drug versions launch?

Generic name: pasireotide pamoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 24, 2027
Generic Entry Controlled by: Denmark Patent 2,164,473

SIGNIFOR LAR is a drug marketed by Recordati Rare. There are three patents protecting this drug.

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

See drug price trends for SIGNIFOR LAR.

The generic ingredient in SIGNIFOR LAR is pasireotide pamoate. One supplier is listed for this generic product. Additional details are available on the pasireotide pamoate profile page.

When can TRELSTAR (triptorelin pamoate) generic drug versions launch?

Generic name: triptorelin pamoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 06, 2027
Generic Entry Controlled by: Denmark Patent 2,164,467

TRELSTAR is a drug marketed by Verity. There is one patent protecting this drug.

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

See drug price trends for TRELSTAR.

The generic ingredient in TRELSTAR is triptorelin pamoate. There are three drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the triptorelin pamoate profile page.

When can TRELSTAR (triptorelin pamoate) generic drug versions launch?

Generic name: triptorelin pamoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 06, 2027
Generic Entry Controlled by: Denmark Patent 2,500,014

TRELSTAR is a drug marketed by Verity. There is one patent protecting this drug.

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

See drug price trends for TRELSTAR.

The generic ingredient in TRELSTAR is triptorelin pamoate. There are three drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the triptorelin pamoate profile page.

When can TRIPTODUR KIT (triptorelin pamoate) generic drug versions launch?

Generic name: triptorelin pamoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 06, 2027
Generic Entry Controlled by: Denmark Patent 2,164,467

TRIPTODUR KIT is a drug marketed by Azurity. There is one patent protecting this drug.

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

The generic ingredient in TRIPTODUR KIT is triptorelin pamoate. There are three drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the triptorelin pamoate profile page.

When can TRIPTODUR KIT (triptorelin pamoate) generic drug versions launch?

Generic name: triptorelin pamoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 06, 2027
Generic Entry Controlled by: Denmark Patent 2,500,014

TRIPTODUR KIT is a drug marketed by Azurity. There is one patent protecting this drug.

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

The generic ingredient in TRIPTODUR KIT is triptorelin pamoate. There are three drug master file entries for this API. Two suppliers are listed for this generic product. Additional details are available on the triptorelin pamoate profile page.

When can JAKAFI (ruxolitinib phosphate) generic drug versions launch?

Generic name: ruxolitinib phosphate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 13, 2027
Generic Entry Controlled by: Denmark Patent 3,070,090

JAKAFI is a drug marketed by Incyte Corp. There are eight patents protecting this drug and one Paragraph IV challenge.

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

See drug price trends for JAKAFI.

The generic ingredient in JAKAFI is ruxolitinib phosphate. There are two drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the ruxolitinib phosphate profile page.

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

Generic name: vortioxetine hydrobromide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 15, 2027
Generic Entry Controlled by: Denmark Patent 2,044,043

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. Three 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, 2027
Generic Entry Controlled by: Denmark Patent 2,484,346

EMBEDA is a drug marketed by Alpharma Pharms. There are seven 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 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, 2027
Generic Entry Controlled by: Denmark Patent 2,719,378

EMBEDA is a drug marketed by Alpharma Pharms. There are seven 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 KYBELLA (deoxycholic acid) generic drug versions launch?

Generic name: deoxycholic acid
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2027
Generic Entry Controlled by: Denmark Patent 2,407,475

KYBELLA is a drug marketed by Abbvie. There are fourteen patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and forty-six patent family members in thirty-eight countries. There has been litigation on patents covering KYBELLA

The generic ingredient in KYBELLA is deoxycholic acid. There are thirty-three drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the deoxycholic acid profile page.

When can CARDAMYST (etripamil) generic drug versions launch?

Generic name: etripamil
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 20, 2027
Generic Entry Controlled by: Denmark Patent 2,170,050

CARDAMYST is a drug marketed by Milestone Pharms Usa. There are six patents protecting this drug.

This drug has sixty-six patent family members in twenty-nine countries.

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

When can OJEMDA (tovorafenib) generic drug versions launch?

Generic name: tovorafenib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 29, 2027
Generic Entry Controlled by: Denmark Patent 3,231,798

OJEMDA is a drug marketed by Day One Biopharms. There are two patents protecting this drug.

This drug has fifty patent family members in twenty-seven countries.

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

Denmark Branded and Generic Drug Markets: Assessment, Regulatory Opportunities, and Challenges

Last updated: December 26, 2025

Executive Summary

Denmark’s pharmaceutical landscape is characterized by a mature, high-income market with a strategic focus on innovation, sustainability, and cost-efficiency. The country’s biopharmaceutical sector is driven by high healthcare standards, strong regulatory frameworks, and an emphasis on access to innovative therapies. While the Danish market presents attractive opportunities for both branded and generic drug manufacturers, it also encounters unique challenges rooted in regulatory policies, market dynamics, and economic factors. This comprehensive analysis explores Denmark’s pharmaceutical market structure, assesses opportunities for market entry and expansion, and evaluates regulatory hurdles and strategic considerations.


Market Overview

Danish Pharmaceutical Market Size and Composition

Aspect Details
Estimated Market Size (2022) Approximately €3.3 billion [1]
Per Capita Pharmaceutical Spending €570 (average OECD rank)
Market Growth Rate 3-4% CAGR (due to aging population and innovation)
Key Segments Branded drugs (~70%), Generics (~20%), Biosimilars (~10%)

Market Drivers

  • Aging Population: Over 20% of Danes are aged 65+, fueling demand for chronic disease medicines.
  • Healthcare Spending: Denmark spends ~10% of GDP on healthcare [2], supporting access to innovative therapies.
  • Innovation & Biotech: Denmark ranks among EU leaders in biotech innovation, with institutions like Novo Nordisk driving global competitiveness.
  • Regulatory Environment: Harmonized EU regulations streamline approval processes, though localized policies impact market dynamics.

Regulatory Environment in Denmark: An Overview

EU and Danish Regulatory Framework

  • Denmark implements European Medicines Agency (EMA) guidelines, which encompass drug approval, pharmacovigilance, and market surveillance [3].
  • The Danish Medicines Agency (Lægemiddelstyrelsen) oversees national implementation, enforcing compliance with EU directives and Danish-specific policies.

Key Regulatory Features

Feature Details Implication for Market Participants
Market Authorization EMA approval required for new drugs; national procedures are minimal for approved medicines Fast access for innovative drugs but stringent for generics and biosimilars
Price Regulation Managed via tendering and reference pricing [4] Limits pricing flexibility, promotes cost containment
Reimbursement Policies Covered under public healthcare schemes, with strict formulary inclusion criteria Market entry depends on reimbursement negotiations
Data Exclusivity 8+2+1 years (regulatory/data/drug protection) under EU law Delays generic/biosimilar entry post-launch

Opportunities for Branded and Generic Drugs in Denmark

What are the market opportunities?

Segment Opportunities Rationale Key Considerations
Innovative Branded Drugs Entry of new biologics, specialty medicines High demand among aging population and advanced treatments Navigating EMA approval; securing reimbursement
Generics Market penetration of off-patent medicines Cost-saving initiatives; EU-wide policies favor generics Price competition; tender-based procurement
Biosimilars Growing adoption in oncology, diabetes Provides cost-effective alternatives to biologics Ensuring physician acceptance and patient confidence

Strategic Entry Points

  • Early Market Access: Leverage EMA approval pathways and local liaison to accelerate market entry.
  • Partnerships: Collaborate with local distributors, healthcare providers, and academic institutions.
  • Regulatory Engagement: Engage with Danish Medicines Agency early to align regulatory strategies.
  • Pricing & Reimbursement Strategies: Each new product must navigate Denmark’s tender system and reimbursement landscape for commercial success.

Quantitative Market Potential

Drug Type Approximate Market Share Price Range (EUR/unit) Reimbursement Coverage Market Entry Timeline
Branded Biologics €2.3 billion (~70%) €1,000 - €10,000 High 1-3 years post-approval
Generics €660 million (~20%) €10 - €50 Moderate to high 6 months to 1 year
Biosimilars €330 million (~10%) €500 - €3,000 Increasing 1-2 years

Regulatory Challenges Facing Drug Manufacturers

1. Price and Reimbursements Policies

  • Denmark’s public healthcare system emphasizes cost control through tendering and reference pricing mechanisms, which constrain profit margins for new entrants.
  • For branded drugs, achieving price negotiations and reimbursement approval can extend timelines, especially for innovative therapies.

2. Market Access Barriers

  • The requirement for extensive pharmacoeconomic evidence and local clinical data complicates market access, demanding significant investment.
  • Tendering procedures often favor low-cost generics, lessening profitability for branded products.

3. Slow Adoption of Biosimilars

  • Despite EU policies encouraging biosimilar uptake, Danish physicians and payers exhibit cautious acceptance—highlighting a need for targeted educational initiatives.

4. Regulatory Complexity for Biosimilars

  • Bioscindami, the Danish regulatory process, aligns with EMA but requires additional local pharmacovigilance, complicating approval timelines.

5. Patent and Data Exclusivity Issues

  • Post-patent expiry, aggressive patent litigation and data exclusivity periods delay generic and biosimilar entry.

Comparative Policy Insights: Denmark Versus EU and Neighboring Markets

Aspect Denmark EU Average Sweden/Norway Germany/UK
Price Regulation Centralized tendering AAA-based referencing Similar Market-based pricing
Reimbursement Domiciliary scheme Similar Similar Similar
Biosimilar Adoption Moderate High High High
Speed to Market Moderate Fast Fast Fast

Sources: [3], [4], [5]


Strategic Recommendations

For Branded Drug Manufacturers

Action Rationale Implementation Steps
Focus on Innovation Denmark prioritizes high-value therapies Partner with local research centers; demonstrate added value
Early Engagement Accelerate Market Access Engage Danish authorities during EMA approval process
Tailored Pricing Strategies Navigate price controls Leverage pharmacoeconomic data; negotiate early

For Generic and Biosimilar Manufacturers

Action Rationale Implementation Steps
Competitive Pricing Penetrate tender-based market Optimize supply chain; offer volume discounts
Educational Campaigns Increase physician confidence Demonstrate biosimilar safety and efficacy
Strategic Entry Timing Optimize reimbursement window Monitor patent expiry and regulatory approvals

Key Challenges to Overcome

  • Navigating complex reimbursement and tendering procedures.
  • Achieving physician and patient acceptance for biosimilars.
  • Managing regulatory hurdles to accelerate market entry.
  • Competing against established pharmaceutical companies with strong local presence.

Comparative Summary of Opportunities and Challenges

Aspect Opportunities Challenges
Market Size High, with strong growth prospects Price regulation limits margins
Regulatory Environment Harmonized with EU; predictability Stringent approval and reimbursement criteria
Market Access Early engagement can shorten timeframes Pharmacoeconomic requirements
Competition Growing biosimilar uptake Entrenched brand loyalty for originators
Pricing & Reimbursement Cost containment policies drive volume Tendering and reference pricing reduce profit potential

Conclusion

Denmark offers a resilient and sophisticated pharmaceutical market characterized by high standards for innovation, cost containment, and sustainability. While regulatory pathways favor biosimilar adoption and emphasize value-based pricing, market entry—especially for innovative drugs—requires strategic planning, early policy engagement, and local partnerships. Both branded and generic manufacturers can capitalize on demographic and healthcare trends, yet must navigate Denmark’s unique policy environment effectively. Success hinges on delivering value, demonstrating cost-effectiveness, and fostering trust among healthcare providers and payers.


Key Takeaways

  • Denmark’s drug market is ripe with opportunities for innovative therapies, biosimilars, and generics, home to a highly developed healthcare infrastructure.
  • Regulatory pathways are aligned with the EU but are complemented by national policies that emphasize cost control and market access strategies.
  • Price regulation, tendering, and reference pricing are primary challenges necessitating strategic negotiation and local stakeholder engagement.
  • Early engagement with Danish authorities and health providers accelerates market access and adoption.
  • Investment in pharmacoeconomic evidence enhances likelihood of reimbursement and formulary inclusion.

Frequently Asked Questions

1. How does Denmark’s approach to biosimilars compare with neighboring countries?
Denmark exhibits moderate biosimilar adoption, similar to the EU average, but lags behind Sweden and Norway, which have implemented more aggressive educational and incentive programs, leading to higher uptake.

2. What is the typical time frame for drug approval and market access in Denmark?
While EMA approval can take approximately 1 year, additional local regulatory assessments and reimbursement negotiations extend the timeline to 1-3 years for comprehensive market access, depending on the therapy.

3. How significant are price regulations in Denmark’s pharmaceutical market?
Price regulation is a dominant feature, especially for generics and hospital-use drugs, with tendering and reference pricing mechanisms strongly influencing profit margins.

4. Are there specific policies promoting the adoption of biosimilars?
Yes, Denmark’s government actively promotes biosimilar use through tenders, formulary preferences, and educational campaigns, aiming to contain rising biologic spending.

5. What strategies are recommended for new entrants aiming to launch innovative medicines?
Early engagement with authorities, robust pharmacoeconomic evidence, alignment with reimbursement criteria, and collaborations with Danish research institutions are vital to accelerate approval and adoption.


References

[1] Danish Medicines Agency. (2022). Pharmaceutical Market Data.
[2] OECD. (2022). Health at a Glance: Europe 2022.
[3] European Medicines Agency. (2022). EU Regulatory Procedures.
[4] Danish Ministry of Health. (2021). Pharmaceutical Pricing Policies.
[5] IQVIA. (2022). Global Use of Medicine Report.

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