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

Poland: These 46 Drugs Face Patent Expirations and Generic Entry From 2026 - 2027

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Preferred citation:
Friedman, Yali, "Poland: These 46 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 TYMLOS (abaloparatide) generic drug versions launch in Poland?

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

TYMLOS is a drug marketed by Radius. There are nine patents protecting this drug. There has been litigation on patents covering TYMLOS

See drug price trends for TYMLOS.

The generic ingredient in TYMLOS is abaloparatide. Additional details are available on the abaloparatide profile page.

When can COTELLIC (cobimetinib fumarate) generic drug versions launch in Poland?

Generic name: cobimetinib fumarate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: October 05, 2026
Generic Entry Controlled by: Poland Patent 1,934,174

COTELLIC is a drug marketed by Genentech Inc. There are seven patents protecting this drug.

See drug price trends for COTELLIC.

The generic ingredient in COTELLIC is cobimetinib fumarate. Additional details are available on the cobimetinib fumarate profile page.

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

Generic name: sacubitril; valsartan
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: November 08, 2026
Generic Entry Controlled by: Poland Patent 1,948,158

ENTRESTO SPRINKLE is a drug marketed by Novartis. There are three patents protecting this drug. 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. Additional details are available on the sacubitril; valsartan profile page.

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

Generic name: sacubitril; valsartan
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: November 08, 2026
Generic Entry Controlled by: Poland Patent 2,340,828

When can PYLARIFY (piflufolastat f-18) generic drug versions launch in Poland?

Generic name: piflufolastat f-18
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: November 08, 2026
Generic Entry Controlled by: Poland Patent 2,097,111

PYLARIFY is a drug marketed by Progenics Pharms Inc and AphelionThere are six patents protecting this drug.

See drug price trends for PYLARIFY.

The generic ingredient in PYLARIFY is piflufolastat f-18. Additional details are available on the piflufolastat f-18 profile page.

When can PYLARIFY (piflufolastat f-18) generic drug versions launch in Poland?

Generic name: piflufolastat f-18
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: November 08, 2026
Generic Entry Controlled by: Poland Patent 2,942,065

When can PYLARIFY (piflufolastat f-18) generic drug versions launch in Poland?

Generic name: piflufolastat f-18
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: November 08, 2026
Generic Entry Controlled by: Poland Patent 3,699,162

When can PYLARIFY TRUVU (piflufolastat f-18) generic drug versions launch in Poland?

Generic name: piflufolastat f-18
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: November 08, 2026
Generic Entry Controlled by: Poland Patent 2,097,111

PYLARIFY TRUVU is a drug marketed by Aphelion. There are six patents protecting this drug.

The generic ingredient in PYLARIFY TRUVU is piflufolastat f-18. Additional details are available on the piflufolastat f-18 profile page.

When can PYLARIFY TRUVU (piflufolastat f-18) generic drug versions launch in Poland?

Generic name: piflufolastat f-18
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: November 08, 2026
Generic Entry Controlled by: Poland Patent 2,942,065

When can PYLARIFY TRUVU (piflufolastat f-18) generic drug versions launch in Poland?

Generic name: piflufolastat f-18
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: November 08, 2026
Generic Entry Controlled by: Poland Patent 3,699,162

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

Generic name: difelikefalin acetate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: November 10, 2026
Generic Entry Controlled by: Poland Patent 2,064,228

KORSUVA is a drug marketed by Vifor Intl. There are twelve patents protecting this drug. There has been litigation on patents covering KORSUVA

See drug price trends for KORSUVA.

The generic ingredient in KORSUVA is difelikefalin acetate. Additional details are available on the difelikefalin acetate profile page.

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

Generic name: fluciclovine f-18
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: November 28, 2026
Generic Entry Controlled by: Poland Patent 1,978,015

AXUMIN is a drug marketed by Blue Earth. There are eight patents protecting this drug. There has been litigation on patents covering AXUMIN

The generic ingredient in AXUMIN is fluciclovine f-18. Additional details are available on the fluciclovine f-18 profile page.

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

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

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. There has been litigation on patents covering ZUBSOLV

See drug price trends for ZUBSOLV.

The generic ingredient in ZUBSOLV is buprenorphine hydrochloride; naloxone hydrochloride. Additional details are available on the buprenorphine hydrochloride; naloxone hydrochloride profile page.

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

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

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

See drug price trends for SIRTURO.

The generic ingredient in SIRTURO is bedaquiline fumarate. Additional details are available on the bedaquiline fumarate profile page.

When can ZYKADIA (ceritinib) generic drug versions launch in Poland?

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

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

See drug price trends for ZYKADIA.

The generic ingredient in ZYKADIA is ceritinib. Additional details are available on the ceritinib profile page.

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

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

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

See drug price trends for XERMELO.

The generic ingredient in XERMELO is telotristat etiprate. Additional details are available on the telotristat etiprate profile page.

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

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

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

Generic name: ingenol mebutate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: December 18, 2026
Generic Entry Controlled by: Poland Patent 1,988,877

PICATO is a drug marketed by Leo Labs. There are twelve patents protecting this drug and one Paragraph IV challenge. One tentatively approved generic is ready to enter the market. There has been litigation on patents covering PICATO

See drug price trends for PICATO.

The generic ingredient in PICATO is ingenol mebutate. Additional details are available on the ingenol mebutate profile page.

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

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

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

The generic ingredient in VYKAT XR is diazoxide choline. Additional details are available on the diazoxide choline profile page.

When can SEYSARA (sarecycline hydrochloride) generic drug versions launch in Poland?

Generic name: sarecycline hydrochloride
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: December 21, 2026
Generic Entry Controlled by: Poland Patent 2,120,963

SEYSARA is a drug marketed by Almirall. There are four patents protecting this drug.

See drug price trends for SEYSARA.

The generic ingredient in SEYSARA is sarecycline hydrochloride. Additional details are available on the sarecycline hydrochloride profile page.

When can ICLUSIG (ponatinib hydrochloride) generic drug versions launch in Poland?

Generic name: ponatinib hydrochloride
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: December 22, 2026
Generic Entry Controlled by: Poland Patent 1,973,545

ICLUSIG is a drug marketed by Takeda Pharms Usa. There are six patents protecting this drug. One tentatively approved generic is ready to enter the market. There has been litigation on patents covering ICLUSIG

See drug price trends for ICLUSIG.

The generic ingredient in ICLUSIG is ponatinib hydrochloride. Additional details are available on the ponatinib hydrochloride profile page.

When can ICLUSIG (ponatinib hydrochloride) generic drug versions launch in Poland?

Generic name: ponatinib hydrochloride
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: December 22, 2026
Generic Entry Controlled by: Poland Patent 2,495,016

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

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

OSENI is a drug marketed by Takeda Pharms Usa. There are two patents protecting this drug. There has been litigation on patents covering OSENI

See drug price trends for OSENI.

The generic ingredient in OSENI is alogliptin benzoate; pioglitazone hydrochloride. Additional details are available on the alogliptin benzoate; pioglitazone hydrochloride profile page.

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

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

PANCREAZE is a drug marketed by

See drug price trends for PANCREAZE.

The generic ingredient in PANCREAZE is pancrelipase (amylase;lipase;protease). Additional details are available on the pancrelipase (amylase;lipase;protease) profile page.

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

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

ZENPEP is a drug marketed by

See drug price trends for ZENPEP.

The generic ingredient in ZENPEP is pancrelipase (amylase;lipase;protease). Additional details are available on the pancrelipase (amylase;lipase;protease) profile page.

When can PRESTALIA (amlodipine besylate; perindopril arginine) generic drug versions launch in Poland?

Generic name: amlodipine besylate; perindopril arginine
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: February 26, 2027
Generic Entry Controlled by: Poland Patent 1,989,182

PRESTALIA is a drug marketed by Adhera. There is one patent protecting this drug and one Paragraph IV challenge. There has been litigation on patents covering PRESTALIA

The generic ingredient in PRESTALIA is amlodipine besylate; perindopril arginine. Additional details are available on the amlodipine besylate; perindopril arginine profile page.

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

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

XENLETA is a drug marketed by Hong Kong. There are four patents protecting this drug. 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 AMYVID (florbetapir f-18) generic drug versions launch in Poland?

Generic name: florbetapir f-18
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: March 26, 2027
Generic Entry Controlled by: Poland Patent 1,999,109

AMYVID is a drug marketed by Avid Radiopharms Inc. There are two patents protecting this drug. There has been litigation on patents covering AMYVID

The generic ingredient in AMYVID is florbetapir f-18. Additional details are available on the florbetapir f-18 profile page.

When can AMYVID (florbetapir f-18) generic drug versions launch in Poland?

Generic name: florbetapir f-18
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: March 26, 2027
Generic Entry Controlled by: Poland Patent 2,363,392

When can INLYTA (axitinib) generic drug versions launch in Poland?

Generic name: axitinib
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: April 05, 2027
Generic Entry Controlled by: Poland Patent 2,134,702

INLYTA is a drug marketed by Pf Prism Cv. There are four patents protecting this drug and one Paragraph IV challenge. Two tentatively approved generics are ready to enter the market. There has been litigation on patents covering INLYTA

See drug price trends for INLYTA.

The generic ingredient in INLYTA is axitinib. Additional details are available on the axitinib profile page.

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

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

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

The generic ingredient in SYMDEKO (COPACKAGED) is ivacaftor; ivacaftor, tezacaftor. Additional details are available on the ivacaftor; ivacaftor, tezacaftor profile page.

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

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

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

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

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

Generic name: ivacaftor; ivacaftor, tezacaftor
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: April 09, 2027
Generic Entry Controlled by: Poland Patent 3,327,016

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

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

PROMACTA is a drug marketed by Novartis. There is one patent protecting this drug and two Paragraph IV challenges. There has been litigation on patents covering PROMACTA

See drug price trends for PROMACTA.

The generic ingredient in PROMACTA is eltrombopag olamine. Additional details are available on the eltrombopag olamine profile page.

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

Generic name: eltrombopag olamine
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: May 03, 2027
Generic Entry Controlled by: Poland Patent 3,090,730

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

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

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

Generic name: eltrombopag olamine
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: May 03, 2027
Generic Entry Controlled by: Poland Patent 4,400,104

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

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

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

See drug price trends for SIGNIFOR LAR.

The generic ingredient in SIGNIFOR LAR is pasireotide pamoate. Additional details are available on the pasireotide pamoate profile page.

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

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

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

See drug price trends for TRELSTAR.

The generic ingredient in TRELSTAR is triptorelin pamoate. Additional details are available on the triptorelin pamoate profile page.

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

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

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

The generic ingredient in TRIPTODUR KIT is triptorelin pamoate. Additional details are available on the triptorelin pamoate profile page.

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

Generic name: ruxolitinib phosphate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: June 13, 2027
Generic Entry Controlled by: Poland Patent 2,173,752

JAKAFI is a drug marketed by Incyte Corp. There are nineteen patents protecting this drug and one Paragraph IV challenge. There has been litigation on patents covering JAKAFI

See drug price trends for JAKAFI.

The generic ingredient in JAKAFI is ruxolitinib phosphate. Additional details are available on the ruxolitinib phosphate profile page.

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

Generic name: ruxolitinib phosphate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: June 13, 2027
Generic Entry Controlled by: Poland Patent 2,740,731

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

Generic name: morphine sulfate; naltrexone hydrochloride
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2027
Generic Entry Controlled by: Poland Patent 2,526,932

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

See drug price trends for EMBEDA.

The generic ingredient in EMBEDA is morphine sulfate; naltrexone hydrochloride. Additional details are available on the morphine sulfate; naltrexone hydrochloride profile page.

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

Generic name: morphine sulfate; naltrexone hydrochloride
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2027
Generic Entry Controlled by: Poland Patent 2,719,378

When can CARDAMYST (etripamil) generic drug versions launch in Poland?

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

CARDAMYST is a drug marketed by Milestone Pharms Usa. There are six patents protecting this drug. There has been litigation on patents covering CARDAMYST

See drug price trends for CARDAMYST.

The generic ingredient in CARDAMYST is etripamil. Additional details are available on the etripamil profile page.

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

Generic name: remimazolam besylate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: July 10, 2027
Generic Entry Controlled by: Poland Patent 2,081,921

BYFAVO is a drug marketed by Acacia. There are eleven patents protecting this drug. There has been litigation on patents covering BYFAVO

See drug price trends for BYFAVO.

The generic ingredient in BYFAVO is remimazolam besylate. Additional details are available on the remimazolam besylate profile page.

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

Generic name: adapalene; benzoyl peroxide
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: July 12, 2027
Generic Entry Controlled by: Poland Patent 2,046,318

EPIDUO is a drug marketed by Galderma Labs Lp and Galderma LabsThere are three patents protecting this drug and two Paragraph IV challenges. There has been litigation on patents covering EPIDUO

See drug price trends for EPIDUO.

The generic ingredient in EPIDUO is adapalene; benzoyl peroxide. Additional details are available on the adapalene; benzoyl peroxide profile page.

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

Generic name: adapalene; benzoyl peroxide
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: July 12, 2027
Generic Entry Controlled by: Poland Patent 2,450,035

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

Generic name: adapalene; benzoyl peroxide
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: July 12, 2027
Generic Entry Controlled by: Poland Patent 2,046,318

EPIDUO FORTE is a drug marketed by Galderma Labs. 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. Additional details are available on the adapalene; benzoyl peroxide profile page.

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

Generic name: adapalene; benzoyl peroxide
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: July 12, 2027
Generic Entry Controlled by: Poland Patent 2,450,035

When can TEPMETKO (tepotinib hydrochloride) generic drug versions launch in Poland?

Generic name: tepotinib hydrochloride
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: July 12, 2027
Generic Entry Controlled by: Poland Patent 2,164,843

TEPMETKO is a drug marketed by Emd Serono Inc. There are eight patents protecting this drug. There has been litigation on patents covering TEPMETKO

See drug price trends for TEPMETKO.

The generic ingredient in TEPMETKO is tepotinib hydrochloride. Additional details are available on the tepotinib hydrochloride profile page.

When can TEPMETKO (tepotinib hydrochloride) generic drug versions launch in Poland?

Generic name: tepotinib hydrochloride
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: July 12, 2027
Generic Entry Controlled by: Poland Patent 2,164,844

When can TEPMETKO (tepotinib hydrochloride) generic drug versions launch in Poland?

Generic name: tepotinib hydrochloride
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: July 12, 2027
Generic Entry Controlled by: Poland Patent 2,754,660

When can TRIFERIC (ferric pyrophosphate citrate) generic drug versions launch in Poland?

Generic name: ferric pyrophosphate citrate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: July 20, 2027
Generic Entry Controlled by: Poland Patent 2,016,940

TRIFERIC is a drug marketed by Rockwell Medical Inc. There are two patents protecting this drug.

See drug price trends for TRIFERIC.

The generic ingredient in TRIFERIC is ferric pyrophosphate citrate. Additional details are available on the ferric pyrophosphate citrate profile page.

When can TRIFERIC AVNU (ferric pyrophosphate citrate) generic drug versions launch in Poland?

Generic name: ferric pyrophosphate citrate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: July 20, 2027
Generic Entry Controlled by: Poland Patent 2,016,940

TRIFERIC AVNU is a drug marketed by Rockwell Medical Inc. There is one patent protecting this drug.

See drug price trends for TRIFERIC AVNU.

The generic ingredient in TRIFERIC AVNU is ferric pyrophosphate citrate. Additional details are available on the ferric pyrophosphate citrate profile page.

When can MULPLETA (lusutrombopag) generic drug versions launch in Poland?

Generic name: lusutrombopag
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: July 31, 2027
Generic Entry Controlled by: Poland Patent 2,184,279

MULPLETA is a drug marketed by Vancocin Italia. There are three patents protecting this drug.

See drug price trends for MULPLETA.

The generic ingredient in MULPLETA is lusutrombopag. Additional details are available on the lusutrombopag profile page.

When can WINLEVI (clascoterone) generic drug versions launch in Poland?

Generic name: clascoterone
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: August 03, 2027
Generic Entry Controlled by: Poland Patent 2,173,891

WINLEVI is a drug marketed by Sun Pharm. There are eight patents protecting this drug. There has been litigation on patents covering WINLEVI

See drug price trends for WINLEVI.

The generic ingredient in WINLEVI is clascoterone. Additional details are available on the clascoterone profile page.

When can WINLEVI (clascoterone) generic drug versions launch in Poland?

Generic name: clascoterone
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: August 03, 2027
Generic Entry Controlled by: Poland Patent 2,503,004

When can WINLEVI (clascoterone) generic drug versions launch in Poland?

Generic name: clascoterone
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: August 03, 2027
Generic Entry Controlled by: Poland Patent 2,503,005

When can WINLEVI (clascoterone) generic drug versions launch in Poland?

Generic name: clascoterone
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: August 03, 2027
Generic Entry Controlled by: Poland Patent 2,966,175

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

Generic name: daclatasvir dihydrochloride
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: August 09, 2027
Generic Entry Controlled by: Poland Patent 2,049,522

DAKLINZA is a drug marketed by Bristol-myers Squibb. There are five patents protecting this drug. There has been litigation on patents covering DAKLINZA

See drug price trends for DAKLINZA.

The generic ingredient in DAKLINZA is daclatasvir dihydrochloride. Additional details are available on the daclatasvir dihydrochloride profile page.

When can LOCAMETZ (gallium ga-68 gozetotide) generic drug versions launch in Poland?

Generic name: gallium ga-68 gozetotide
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: August 17, 2027
Generic Entry Controlled by: Poland Patent 2,187,965

LOCAMETZ is a drug marketed by Novartis. There are two patents protecting this drug.

See drug price trends for LOCAMETZ.

The generic ingredient in LOCAMETZ is gallium ga-68 gozetotide. Additional details are available on the gallium ga-68 gozetotide profile page.

When can VIZAMYL (flutemetamol f-18) generic drug versions launch in Poland?

Generic name: flutemetamol f-18
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: August 30, 2027
Generic Entry Controlled by: Poland Patent 2,182,988

VIZAMYL is a drug marketed by Ge Healthcare. There is one patent protecting this drug.

See drug price trends for VIZAMYL.

The generic ingredient in VIZAMYL is flutemetamol f-18. Additional details are available on the flutemetamol f-18 profile page.

When can MYRBETRIQ (mirabegron) generic drug versions launch in Poland?

Generic name: mirabegron
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: November 02, 2027
Generic Entry Controlled by: Poland Patent 2,216,021

MYRBETRIQ is a drug marketed by Apgdi. There are six patents protecting this drug and one Paragraph IV challenge. Two tentatively approved generics are ready to enter the market. There has been litigation on patents covering MYRBETRIQ

See drug price trends for MYRBETRIQ.

The generic ingredient in MYRBETRIQ is mirabegron. Additional details are available on the mirabegron profile page.

When can VELPHORO (sucroferric oxyhydroxide) generic drug versions launch in Poland?

Generic name: sucroferric oxyhydroxide
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: November 16, 2027
Generic Entry Controlled by: Poland Patent 2,222,285

VELPHORO is a drug marketed by Vifor Fresenius. There are eleven patents protecting this drug. There has been litigation on patents covering VELPHORO

See drug price trends for VELPHORO.

The generic ingredient in VELPHORO is sucroferric oxyhydroxide. Additional details are available on the sucroferric oxyhydroxide profile page.

When can VELPHORO (sucroferric oxyhydroxide) generic drug versions launch in Poland?

Generic name: sucroferric oxyhydroxide
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: November 16, 2027
Generic Entry Controlled by: Poland Patent 3,492,069

When can ZEMDRI (plazomicin sulfate) generic drug versions launch in Poland?

Generic name: plazomicin sulfate
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: November 21, 2027
Generic Entry Controlled by: Poland Patent 2,217,610

ZEMDRI is a drug marketed by Cipla Usa. There are four patents protecting this drug. There has been litigation on patents covering ZEMDRI

See drug price trends for ZEMDRI.

The generic ingredient in ZEMDRI is plazomicin sulfate. Additional details are available on the plazomicin sulfate profile page.

When can DUZALLO (allopurinol; lesinurad) generic drug versions launch in Poland?

Generic name: allopurinol; lesinurad
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: November 27, 2027
Generic Entry Controlled by: Poland Patent 2,217,577

DUZALLO is a drug marketed by Ironwood Pharms Inc. There are eight patents protecting this drug. There has been litigation on patents covering DUZALLO

See drug price trends for DUZALLO.

The generic ingredient in DUZALLO is allopurinol; lesinurad. Additional details are available on the allopurinol; lesinurad profile page.

When can ZURAMPIC (lesinurad) generic drug versions launch in Poland?

Generic name: lesinurad
DrugPatentWatch^® Estimated Key Patent Expiration / Generic Entry Date: November 27, 2027
Generic Entry Controlled by: Poland Patent 2,217,577

ZURAMPIC is a drug marketed by Ironwood Pharms Inc. There are eight patents protecting this drug. There has been litigation on patents covering ZURAMPIC

See drug price trends for ZURAMPIC.

The generic ingredient in ZURAMPIC is lesinurad. Additional details are available on the lesinurad profile page.

Last updated: May 12, 2026

Poland Branded vs Generic Drug Market Assessment, Regulatory Opportunities and Barriers (2026 Outlook)

Poland’s drug market combines rising generic penetration with regulatory friction around pricing, reimbursement, and tender procurement. Branded products still command value in patented and protected segments, but commercial headwinds intensify as payer formularies, HTA thresholds, and procurement rules push volume toward lowest-cost options. The most actionable opportunities cluster in (1) lifecycle management around formulation and line-extensions, (2) value-based or budget-impact aligned launches, and (3) specialty and hospital-led pathways where switchability is constrained. The key challenges are compressed net pricing driven by clawbacks and external reference pricing, higher evidence expectations for reimbursement, and procurement mechanisms that can neutralize incremental clinical differentiation.

How big is the branded and generic drug market in Poland and where is growth coming from?

Poland is a single-payer reimbursement system with parallel private out-of-pocket purchasing and regulated wholesale distribution. Market outcomes are determined less by branded versus generic label and more by reimbursement access, tender outcomes, and net price after rebates and clawbacks. The branded share remains meaningful in high-cost categories and originator-protected indications. The generic share grows fastest in mature therapeutic areas where reimbursement favors low-cost products.

Demand drivers that shift volume to generics

Reimbursement rulemaking that favors lower prices in managed lists and tendered hospital supply.
Competitive entry around patent expiry and line-extension windows.
Patient access via pharmacies increases when generics are reimbursed and listed on pharmacy benefit lists.

Where branded products hold value

Specialty drugs with higher clinical value or limited interchangeability.
Products with meaningful “last mile” differentiation that reduces switch rates (dose form, dosing regimen, patient subgroup constraints).
Indications where payers require stronger comparative or budget-impact evidence.

Commercial segmentation that matters for IP and licensing

Hospital tenders: price-led procurement can override branded differentiation.
Outpatient reimbursement: formulary and therapeutic program placement drive volume stability.
Wholesale contracting: margin structure and supply reliability affect bid competitiveness.

What is the regulatory structure in Poland for drug approval, reimbursement, and pricing?

Poland’s framework combines EU-level authorization with national rules for pricing and reimbursement. The operational bottlenecks for brand protection and generic entry occur in pricing, reimbursement inclusion, and procurement.

EU authorization via EMA, national levers via Polish systems

Marketing authorization is EU-wide (EMA centralized procedure or national procedures).
Post-authorization commercial status is Poland-specific through:
- reimbursement decision processes,
- pricing determination and adjustments,
- hospital tender participation rules.

Reimbursement and HTA expectations

Poland’s reimbursement architecture is influenced by:

budget impact,
comparative clinical benefit,
cost-effectiveness thresholds and evidence quality,
negotiations on price and patient access.

Pricing pressures

Net pricing reflects:

externally referenced pricing dynamics,
statutory or negotiated rebate mechanics,
category-specific pricing ceilings or regulation.

How does Poland’s reimbursement process affect brand exclusivity and generic entry timing?

Brand exclusivity impact

Even with patent protection, commercial access depends on reimbursement positioning. Originators often need to lock reimbursement early to preserve market share until generics arrive.
Line extensions and formulation changes can extend reimbursement value if evidence supports added clinical utility or improved patient outcomes that payers accept.

Generic entry impact

Generic or biosimilar entry can be delayed commercially when reimbursement and tender placement take longer than regulatory marketing authorization.
A generic can gain distribution quickly if:
- reimbursement listing is favorable,
- tender bids are competitive on net price,
- interchangeability and substitution rules align with local pharmacy practice.

Timing reality for planning

The limiting factor is typically payer inclusion and tender readiness, not EMA or national authorization.
Patent expiry and 180-day market exclusivity (where applicable in EU/Member State contexts for generics) matter only if the payer process is synchronized.

What patents protect branded drugs in Poland and how enforceable is the IP estate?

In Poland, enforcement is governed by national patent law within the EU IP framework. The practical enforceability of an originator’s patent estate affects:

whether generics can launch “at risk,”
whether patent disputes become settlement-driven entry delays,
whether litigation blocks tenders or only delays manufacturing/distribution.

How the patent estate is typically structured

Originators commonly defend:

compound (active ingredient) patents,
composition-of-matter or salts,
formulation patents (controlled release, excipients, device-linked),
method-of-use patents (indication-specific),
process patents (manufacturing method),
additional regulatory protection via SPC where eligible.

SPC and lifecycle

SPCs can add years to exclusivity where statutory conditions are met, shifting the generic entry risk profile for:

new formulations,
new dosages,
new patient subgroups.

Enforcement bottleneck

Even strong patents do not guarantee rapid injunction outcomes. Distribution and procurement timelines can determine real-world impact.

When does exclusivity lose value in Poland: patent expiry, reimbursement, or procurement?

Exclusivity has three “death dates” in practice:

Legal exclusivity (patent/SPC and data exclusivity).
Reimbursement access (whether the originator retains dominant listing status).
Procurement switch (tender outcomes that move volume to lowest-cost interchangeable products).

Most common commercial transition pattern

After legal exclusivity ends, generics may still face short-term friction until reimbursement and tender awards switch.
Conversely, an originator can lose value before patent expiry if:
- price negotiations reduce net profitability,
- payers shift to value-based or budget-impact frameworks,
- a competitor wins hospital tenders through price.

What does Poland’s biosimilar environment mean for risk and opportunities versus generics?

Biosimilars behave differently from small-molecule generics:

interchangeability assumptions and clinical switching policies drive uptake,
tender structures may still be price-led but clinical governance can constrain substitution.

Opportunity zones

Portfolio expansion by biosimilar developers aligned with hospital formularies.
Tender-ready supply and demonstrated manufacturing consistency.

Risk zones

Evidence expectations for switching or clinical acceptance by local treatment guidelines.
Patent and data exclusivity disputes (biosimilar “at risk” challenges are common in the category globally).
Procurement contract terms that can delay switching even after authorization.

Which therapeutic areas in Poland favor branded medicines and which favor generics?

Generics tend to dominate

off-patent small molecules,
chronic therapies with standardized dosing where switching is routine,
high-volume cardiovascular and metabolic segments.

Branded and specialty-biased segments

oncology and immunology,
high-cost hospital-administered medicines,
therapies with complex dosing, patient selection, or where local clinical guidelines emphasize brand stability.

Procurement effect

Hospital tendering often accelerates switch to lowest-cost supply if clinical protocols allow interchange.
If clinical pathways require specific products, branded share remains longer.

What generic entry risks exist in Poland for products approaching patent expiry?

Generic launch risk in Poland is typically a composite of:

patent litigation exposure,
reimbursement timing,
tender acceptance and contract award structures,
pricing and rebate negotiations.

Key risk categories

Patent risk: injunctions or settlement-driven delays.
Market access risk: reimbursement listing delays can keep generics out of pharmacy uptake.
Pricing risk: aggressive reimbursement compression can reduce bid attractiveness, especially for lower-margin generic manufacturers.
Operational risk: tender qualification and supply constraints can delay volume capture.

How do hospital tenders and procurement rules shape Poland’s generic uptake?

Hospital procurement is often price-competitive and contract-based. For market entry planning:

winning bids are strongly correlated with net price offers,
supply reliability affects award retention and re-bidding,
contracting cycles can create step-function changes in volume.

Implication for brand strategy

Originators may need procurement-specific contracting or differentiated supply arrangements.
Lifecycle extensions only matter if they remain competitive in tender frameworks.

Implication for generic strategy

Tender readiness (paperwork, QA documentation, manufacturing capacity) matters as much as patent status and authorization.

What is the Orange Book status of drugs in Poland?

There is no direct “Orange Book” equivalent used in the US system for Poland. Poland’s market transparency tools differ by:

reimbursement lists and pricing regulations,
marketing authorization records,
procurement tender documentation.

Because the request is Poland-specific, a crosswalk to a US-style “Orange Book” framework is not applicable.

Which companies are positioned for branded growth and which for generic volume in Poland?

Portfolio leaders in Poland mirror broader EU category specialization:

originator and large pharma companies maintain branded share where exclusivity and clinical acceptance remain.
established generic and biosimilar manufacturers lead where procurement and reimbursement favor low-cost supply.

Commercial reality

Winning depends on reimbursement acceptance and tender participation, not just manufacturing scale.
Local distributors and tender experience can determine award likelihood for both brand and generic bids.

What formulation and method-of-use patents matter most for the Poland lifecycle strategy?

Lifecycle value in Poland is typically protected through patents that survive the commercial test:

formulation patents that support a differentiated dose form or release profile,
method-of-use patents that align with local treatment guidelines,
process patents that support manufacturing advantages relevant to supply continuity.

Formulation-driven value retention

controlled-release differentiation can justify continued clinical preference and reimbursement negotiation positions.

Method-of-use value retention

indication-specific evidence can slow payer-driven substitution where guidelines specify a branded product.

What patent litigation affects drug supply or reimbursement outcomes in Poland?

Patent litigation can affect Poland’s market in three ways:

delays in generic launch or distribution,
settlement-driven “agree-to-delay” outcomes,
injunction risk that changes tender or pharmacy stocking behavior.

Where litigation creates measurable commercial impact

hospital procurement cycles,
contracted pharmacy distribution agreements,
pipeline timing for generic manufacturers preparing multiple strengths.

How do licensing and settlement agreements change generic launch scenarios in Poland?

Settlements often convert litigation uncertainty into:

delayed market entry,
royalty or supply arrangements,
carve-outs for specific strengths or indications.

Practical commercial effects

even if legal barriers end, settlement structures can extend exclusivity-like behavior.
tender outcomes can be partially insulated from early competition depending on agreement scope.

What are regulatory opportunities for new entrants in Poland: faster pathways, evidence strategies, and market access?

Regulatory opportunity categories

Launch strategies that pair evidence packages with budget-impact negotiation readiness.
Evidence for comparative effectiveness and real-world relevant endpoints that align with reimbursement criteria.
“Tender-ready” dossier and operational plan for rapid supply once listing is secured.

Commercial opportunity categories

specialty and hospital pathways where clinical governance slows switching,
line extensions with formulation improvements that are reimbursable,
product positioning aligned with therapeutic programs.

What regulatory challenges block growth: evidence burden, pricing controls, and procurement friction?

Poland’s most material barriers are economic and administrative:

net price compression through reimbursement and pricing adjustments,
rebate and clawback effects that reduce predictable margin,
administrative timing for reimbursement inclusion that can miss clinical tender windows,
procurement rules that favor lowest net cost, compressing value captured by differentiation.

Poland branded vs generic: comparison framework for investors and licensing teams

Dimension	Branded originators	Generics	Biosimilars
Primary success metric	Reimbursement access + tender presence	Reimbursement listing + lowest net price + tender wins	Clinical acceptance + tender substitution + supply reliability
Main pressure	Price negotiations and payer value thresholds	Litigation + reimbursement timing	Biosimilar-specific evidence and switching governance
Typical value curve	Steady pre-expiry, then decline post-loss of coverage	Step-change gains post-listing and tender awards	Gradual gains tied to treatment guideline and hospital practice
Differentiation lever	Formulation, indication data, lifecycle patents	Cost, supply, and dossier speed	Clinical acceptance data + manufacturing reliability
Biggest risk	Losing payer position before patent expiry	Launch blocked by litigation or reimbursement delay	Switch barriers and contract constraints

Revenue exposure model: where net pricing compression hits hardest

Because reimbursement is the central commercial gate, the revenue exposure for branded companies often comes from:

price cuts after negotiation cycles,
volume loss in tendered hospitals due to generic switching,
replacement of branded stocks with lower-cost options after tender re-awards.

For generics, revenue exposure concentrates in:

tender bid margin erosion from pricing controls and rebate mechanics,
increased competition with multiple parallel generic suppliers,
reimbursement listing volatility across strengths and pack sizes.

Key Takeaways

Poland’s branded and generic markets are governed primarily by reimbursement inclusion and hospital tender economics, not just patent status.
Branded products retain value in specialty and clinically governed segments; generics scale fastest in tender- and reimbursement-driven therapeutic areas.
The practical exclusivity “end” in Poland is usually defined by reimbursement and procurement shift timing after legal expiry.
Regulatory opportunity favors entrants that can align evidence and budget-impact narratives with payer requirements and execute fast, tender-ready supply.
Core challenges are net pricing compression, administrative friction in reimbursement, and litigation exposure that can delay generic and biosimilar uptake.

FAQs

1) How do tender cycles affect the ramp-up of generics in Poland after authorization?
Tender award timing often drives stepwise volume capture, with ramp-up accelerating only after inclusion in procurement contracts.

2) What evidence package improves generic reimbursement odds in Poland?
Reimbursement success depends on alignment with comparative clinical expectations and strong administrative dossier completeness for listing.

3) Do lifecycle formulation changes extend reimbursement access in Poland?
They can, if payers accept clinical or patient-relevant advantages and if reimbursement negotiation supports the incremental value.

4) Are biosimilar switches primarily determined by pricing or clinical governance in Poland?
Pricing drives tender outcomes, while clinical governance and local practice can constrain automatic substitution.

5) What is the main risk to a “patent-expiry launch” strategy in Poland?
Reimbursement listing timing and tender readiness can delay commercial entry even when legal barriers are cleared.

References

No sources are cited because the request requires Poland-specific market, regulatory, and patent details that were not provided in the prompt.

Poland Branded vs Generic Drug Market Assessment, Regulatory Opportunities and Barriers (2026 Outlook)

How big is the branded and generic drug market in Poland and where is growth coming from?

What is the regulatory structure in Poland for drug approval, reimbursement, and pricing?

EU authorization via EMA, national levers via Polish systems

Reimbursement and HTA expectations

Pricing pressures

How does Poland’s reimbursement process affect brand exclusivity and generic entry timing?

What patents protect branded drugs in Poland and how enforceable is the IP estate?

How the patent estate is typically structured

SPC and lifecycle

Enforcement bottleneck

When does exclusivity lose value in Poland: patent expiry, reimbursement, or procurement?

What does Poland’s biosimilar environment mean for risk and opportunities versus generics?

Opportunity zones

Risk zones

Which therapeutic areas in Poland favor branded medicines and which favor generics?

What generic entry risks exist in Poland for products approaching patent expiry?

Key risk categories

How do hospital tenders and procurement rules shape Poland’s generic uptake?

What is the Orange Book status of drugs in Poland?

Which companies are positioned for branded growth and which for generic volume in Poland?

What formulation and method-of-use patents matter most for the Poland lifecycle strategy?

What patent litigation affects drug supply or reimbursement outcomes in Poland?

How do licensing and settlement agreements change generic launch scenarios in Poland?

What are regulatory opportunities for new entrants in Poland: faster pathways, evidence strategies, and market access?

What regulatory challenges block growth: evidence burden, pricing controls, and procurement friction?

Poland branded vs generic: comparison framework for investors and licensing teams

Revenue exposure model: where net pricing compression hits hardest

Key Takeaways

FAQs

References

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