Last Updated: June 27, 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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Croatia: These 29 Drugs Face Patent Expirations and Generic Entry From 2026 - 2027

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Preferred citation:
Friedman, Yali, "Croatia: These 29 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 BYDUREON (exenatide synthetic) generic drug versions launch in Croatia?

Generic name: exenatide synthetic
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Croatia Patent P20141007

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 in Croatia?

Generic name: dapagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Croatia Patent P20141007

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

This drug has four hundred and twenty-seven patent family members in fifty-three 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-four 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 in Croatia?

Generic name: dapagliflozin; saxagliptin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 28, 2026
Generic Entry Controlled by: Croatia Patent P20141007

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 in Croatia?

Generic name: atazanavir sulfate; cobicistat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 07, 2026
Generic Entry Controlled by: Croatia Patent P20150744

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 in Croatia?

Generic name: atazanavir sulfate; cobicistat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 07, 2026
Generic Entry Controlled by: Croatia Patent P20161371

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 in Croatia?

Generic name: atazanavir sulfate; cobicistat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 07, 2026
Generic Entry Controlled by: Croatia Patent P20161476

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 in Croatia?

Generic name: atazanavir sulfate; cobicistat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 07, 2026
Generic Entry Controlled by: Croatia Patent P20161502

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 RASUVO (methotrexate) generic drug versions launch in Croatia?

Generic name: methotrexate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 21, 2026
Generic Entry Controlled by: Croatia Patent P20110148

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 DAKLINZA (daclatasvir dihydrochloride) generic drug versions launch in Croatia?

Generic name: daclatasvir dihydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 11, 2026
Generic Entry Controlled by: Croatia Patent P20140737

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 in Croatia?

Generic name: daclatasvir dihydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 11, 2026
Generic Entry Controlled by: Croatia Patent P20160410

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 in Croatia?

Generic name: daclatasvir dihydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 11, 2026
Generic Entry Controlled by: Croatia Patent P20180496

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 in Croatia?

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 15, 2026
Generic Entry Controlled by: Croatia Patent P20100269

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 in Croatia?

Generic name: ticagrelor
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 21, 2026
Generic Entry Controlled by: Croatia Patent P20170694

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-seven suppliers are listed for this generic product. Additional details are available on the ticagrelor profile page.

When can OPSUMIT (macitentan) generic drug versions launch in Croatia?

Generic name: macitentan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 29, 2026
Generic Entry Controlled by: Croatia Patent P20131233

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. Twelve suppliers are listed for this generic product. Additional details are available on the macitentan profile page.

When can TYMLOS (abaloparatide) generic drug versions launch in Croatia?

Generic name: abaloparatide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 03, 2026
Generic Entry Controlled by: Croatia Patent P20171217

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 COTELLIC (cobimetinib fumarate) generic drug versions launch in Croatia?

Generic name: cobimetinib fumarate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 05, 2026
Generic Entry Controlled by: Croatia Patent P20110498

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

This drug has two hundred and seven patent family members in forty-six countries.

See drug price trends for COTELLIC.

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

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

Generic name: sacubitril; valsartan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 08, 2026
Generic Entry Controlled by: Croatia Patent P20140274

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-six suppliers are listed for this generic product. Additional details are available on the sacubitril; valsartan profile page.

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

Generic name: bedaquiline fumarate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 05, 2026
Generic Entry Controlled by: Croatia Patent P20120639

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 in Croatia?

Generic name: ceritinib
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 08, 2026
Generic Entry Controlled by: Croatia Patent P20141260

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 NESINA (alogliptin benzoate) generic drug versions launch in Croatia?

Generic name: alogliptin benzoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 01, 2027
Generic Entry Controlled by: Croatia Patent P20171518

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

This drug has sixty-nine patent family members in thirty-seven countries. There has been litigation on patents covering NESINA

See drug price trends for NESINA.

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

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

Generic name: alogliptin benzoate; pioglitazone hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 01, 2027
Generic Entry Controlled by: Croatia Patent P20110094

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 XENLETA (lefamulin acetate) generic drug versions launch in Croatia?

Generic name: lefamulin acetate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 20, 2027
Generic Entry Controlled by: Croatia Patent P20110869

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 AMYVID (florbetapir f-18) generic drug versions launch in Croatia?

Generic name: florbetapir f-18
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 26, 2027
Generic Entry Controlled by: Croatia Patent P20120135

AMYVID is a drug marketed by Avid Radiopharms Inc. There are two patents protecting this drug.

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

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

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

Generic name: eltrombopag olamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 03, 2027
Generic Entry Controlled by: Croatia Patent P20160206

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 in Croatia?

Generic name: eltrombopag olamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 03, 2027
Generic Entry Controlled by: Croatia Patent P20240595

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 in Croatia?

Generic name: eltrombopag olamine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 03, 2027
Generic Entry Controlled by: Croatia Patent P20250383

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 TRELSTAR (triptorelin pamoate) generic drug versions launch in Croatia?

Generic name: triptorelin pamoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 06, 2027
Generic Entry Controlled by: Croatia Patent P20161785

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 in Croatia?

Generic name: triptorelin pamoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 06, 2027
Generic Entry Controlled by: Croatia Patent P20181854

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 in Croatia?

Generic name: triptorelin pamoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 06, 2027
Generic Entry Controlled by: Croatia Patent P20161785

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 in Croatia?

Generic name: triptorelin pamoate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 06, 2027
Generic Entry Controlled by: Croatia Patent P20181854

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 XADAGO (safinamide mesylate) generic drug versions launch in Croatia?

Generic name: safinamide mesylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 08, 2027
Generic Entry Controlled by: Croatia Patent P20150136

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 JAKAFI (ruxolitinib phosphate) generic drug versions launch in Croatia?

Generic name: ruxolitinib phosphate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 13, 2027
Generic Entry Controlled by: Croatia Patent P20140541

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 JAKAFI (ruxolitinib phosphate) generic drug versions launch in Croatia?

Generic name: ruxolitinib phosphate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 13, 2027
Generic Entry Controlled by: Croatia Patent P20160717

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 JAKAFI (ruxolitinib phosphate) generic drug versions launch in Croatia?

Generic name: ruxolitinib phosphate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 13, 2027
Generic Entry Controlled by: Croatia Patent P20190385

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 KYBELLA (deoxycholic acid) generic drug versions launch in Croatia?

Generic name: deoxycholic acid
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2027
Generic Entry Controlled by: Croatia Patent P20150879

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 in Croatia?

Generic name: etripamil
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 20, 2027
Generic Entry Controlled by: Croatia Patent P20140801

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. There has been litigation on patents covering CARDAMYST

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 EVOTAZ (atazanavir sulfate; cobicistat) generic drug versions launch in Croatia?

Generic name: atazanavir sulfate; cobicistat
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 06, 2027
Generic Entry Controlled by: Croatia Patent P20090077
Patent Title: MODULATORI FARMAKOKINETIČKIH SVOJSTAVA TERAPEUTIKA (MODULATORS OF PHARMACOKINETIC PROPERTIES OF THERAPEUTICS)

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 TEPMETKO (tepotinib hydrochloride) generic drug versions launch in Croatia?

Generic name: tepotinib hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 12, 2027
Generic Entry Controlled by: Croatia Patent P20120661

TEPMETKO is a drug marketed by Emd Serono Inc. There are eight patents protecting this drug.

This drug has seventy-nine patent family members in thirty-six countries. There has been litigation on patents covering TEPMETKO

See drug price trends for TEPMETKO.

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

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

Generic name: tepotinib hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 12, 2027
Generic Entry Controlled by: Croatia Patent P20150031

TEPMETKO is a drug marketed by Emd Serono Inc. There are eight patents protecting this drug.

This drug has seventy-nine patent family members in thirty-six countries. There has been litigation on patents covering TEPMETKO

See drug price trends for TEPMETKO.

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

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

Generic name: lusutrombopag
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 31, 2027
Generic Entry Controlled by: Croatia Patent P20150062

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

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

See drug price trends for MULPLETA.

The generic ingredient in MULPLETA is lusutrombopag. Three suppliers are listed for this generic product. Additional details are available on the lusutrombopag profile page.

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

Generic name: clascoterone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 03, 2027
Generic Entry Controlled by: Croatia Patent P20140421

Drug Price Trends for WINLEVI
WINLEVI is a drug marketed by Sun Pharm. There are eight patents protecting this drug.

This drug has ninety-four patent family members in thirty countries. There has been litigation on patents covering WINLEVI

See drug price trends for WINLEVI.

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

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

Generic name: clascoterone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 03, 2027
Generic Entry Controlled by: Croatia Patent P20151174

Drug Price Trends for WINLEVI
WINLEVI is a drug marketed by Sun Pharm. There are eight patents protecting this drug.

This drug has ninety-four patent family members in thirty countries. There has been litigation on patents covering WINLEVI

See drug price trends for WINLEVI.

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

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

Generic name: clascoterone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 03, 2027
Generic Entry Controlled by: Croatia Patent P20151298

Drug Price Trends for WINLEVI
WINLEVI is a drug marketed by Sun Pharm. There are eight patents protecting this drug.

This drug has ninety-four patent family members in thirty countries. There has been litigation on patents covering WINLEVI

See drug price trends for WINLEVI.

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

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

Generic name: clascoterone
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 03, 2027
Generic Entry Controlled by: Croatia Patent P20191143

Drug Price Trends for WINLEVI
WINLEVI is a drug marketed by Sun Pharm. There are eight patents protecting this drug.

This drug has ninety-four patent family members in thirty countries. There has been litigation on patents covering WINLEVI

See drug price trends for WINLEVI.

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

Croatia Branded vs Generic Drug Market Assessment, Regulatory Opportunities, and Key Challenges (2026)

Last updated: May 12, 2026

Croatia’s outpatient and reimbursed medicines market is concentrated in a narrow set of high-volume therapeutic categories, with prescribing and access shaped by Croatia’s reimbursement framework, HTA-style budget controls, and national generic substitution rules. For branded entrants, the path depends on winning and maintaining reimbursement listings and complying with pricing and reimbursement updates. For generic and biosimilar players, market entry is anchored to bioequivalence readiness, dossier quality, and navigating price resets and tender-style dynamics in segments where payer governance tightens.

How big is the Croatia branded and generic drug market and what drives demand?

Market structure and demand drivers

  • Croatia is a mature EU member market with a smaller patient base and high influence from reimbursement decisions, reference pricing, and budget impact controls.
  • Demand concentrates in chronic therapies (cardiovascular, diabetes, nervous system, respiratory, gastroenterology) where long treatment durations increase volume stability and generic switching leverage.

What typically drives branded sales

  • Reimbursement placement and formulary positioning under payer rules.
  • Clinical differentiation that supports payer acceptance (or reduced substitution through prescriber constraints).
  • Contracting with payers and hospitals for key therapeutic areas.

What drives generic volume

  • Loss of exclusivity for branded originators.
  • Payer pressure for lowest-cost equivalents through reference pricing and substitution governance.
  • Provider incentives to prescribe generics at scale once lower-cost options are available.

Which therapeutic areas capture the highest growth or replacement risk?

  • High generic replacement risk: branded small-molecule chronic therapies as patents and data exclusivity expire.
  • High branded durability: products with strong differentiation, entrenched guideline positioning, or restricted substitution conditions.
  • Biosimilar adjacency: biologics drive substitution and procurement shifts, but require separate IP and regulatory analysis from small molecules.

What is the Orange Book status of key drugs in Croatia and how does it affect competition?

Croatia does not use the US Orange Book. Instead, market authorization, pricing, and reimbursement status are governed by Croatian national systems that publish reimbursement and pricing-linked information for marketed products. In practice, competition timing is determined by:

  • Whether the product remains in the reimbursed basket at an approved price.
  • Whether payers have moved to reference-priced equivalents.
  • Whether substitution and prescribing rules allow immediate switching.

How do EU regulatory rights translate into Croatia launches?

For small molecules and biologics, EU marketing authorization under the centralized or national route enables entry into Croatia, but commercial timing is shaped by:

  • Croatian reimbursement listing rules and budget caps.
  • Price negotiations and periodic price reviews under Croatian pricing policy.
  • Hospital procurement frameworks that can accelerate or delay utilization shifts.

When does branded exclusivity end in Croatia and what launch windows exist for generics?

Croatian generic entry timing generally follows EU exclusivity and CRO-made pricing/reimbursement conditions rather than any standalone “Croatia exclusivity” clock.

Relevant exclusivity mechanics

  • Regulatory data protection / market exclusivity: derived from EU marketing authorization law.
  • Patent expiry: controls true competitive freedom, including litigation-triggered settlements.
  • Reimbursement and price resets: can cause rapid commercial displacement even after regulatory clearance.

What Paragraph IV-equivalent risk exists in Croatia?

Croatia does not operate an ANDA Paragraph IV framework. Competitive risk is instead driven by:

  • Patent linkage practices and enforcement via national courts or EU-wide patent strategy.
  • Patent term adjustments and supplementary protection certificates (SPCs) that can extend enforceable rights.
  • Settlement agreements that can impose “pay-for-delay” style restrictions through contract and court enforcement mechanisms, where applicable.

How strong is the patent estate for marketed drugs in Croatia and where are enforcement hotspots?

Patent strength in Croatia typically follows the same global patterns: enforcement leverage is highest when:

  • Rights are backed by enforceable SPCs and granted national validations.
  • The product has clear clinical claims (method-of-use or second-medical-use patents).
  • Litigation is used to delay first generic/biosimilar launch.

Which patent types most often block or delay generic competition?

  1. Compound and composition of matter patents
  2. SPCs tied to first approval
  3. Formulation patents (including release and particle-engineering)
  4. Process and manufacturing patents
  5. Use patents (including dosing regimens and subpopulations)

What formulation and manufacturing barriers matter for Croatia generics?

  • Bioequivalence must support substitution at the product level.
  • If branded formulations have protected release characteristics, “same API” does not guarantee freedom to use the same technical profile.
  • Generic manufacturing must avoid infringing process claims where they are active and enforced.

Which regulatory pathway and evidentiary package does Croatia require for generic approval?

Croatia aligns with EU standards for generic medicines and relies on the EU Medicines for Human Use framework.

Generic requirements in practice

  • Bioequivalence evidence for generics unless a waiver applies under EU rules.
  • Quality dossier consistency with EU GMP and pharmacopeial standards.
  • Product information (SmPC and PIL) aligned with the reference product.

What slows Croatia generic approval the most?

  • Bioequivalence study design issues that fail to cover variability and statistical acceptance criteria.
  • Quality module gaps, especially where manufacturing changes occurred between dossier creation and submission.
  • Labeling and SmPC alignment delays, especially for multi-indication products.

What biosimilar risk exists in Croatia and how does it differ from generics?

Biosimilar entry is controlled by:

  • Extrapolation doctrines and biosimilar development comparability.
  • Immunogenicity and reference product matching.
  • Patent families that often include manufacturing and formulation-like claims distinct from small molecules.

How do biosimilar procurement dynamics affect launch outcomes in Croatia?

  • Hospital and payer procurement may shift quickly to biosimilar uptake after approvals.
  • Switching programs are influenced by clinical governance and physician adoption.
  • Pricing negotiation and reference-like reimbursement can accelerate uptake even when prescribers retain choice.

How do Croatian pricing and reimbursement rules create opportunities for branded drugs?

Branded opportunity depends on maintaining or improving reimbursement positioning after launch. For branded sponsors, key pathways include:

  • Demonstrating value through therapeutic advantage and managed entry logic (where used).
  • Contracting and price negotiation with the Croatian payer ecosystem.
  • Avoiding price erosion by maintaining differentiated clinical positioning.

What levers help brands retain share after generic entry begins?

  • Specialty indication separation: keep the reimbursed use narrower than the generic product’s reimbursed scope.
  • Prescriber behavior: if substitution is constrained in certain clinical situations, share decay can slow.
  • Product lifecycle management: line extensions where legally permitted and supported by regulatory approvals.

What are the biggest challenges for generics entering Croatia and scaling revenue?

Commercial constraints

  • Price pressure after listing, often compounded by reference pricing and payer cost containment.
  • Tender-like behavior in certain segments that can compress margins.
  • Limited population increases reliance on reimbursement status for volumes.

Operational constraints

  • Dossier execution quality across EU-aligned technical requirements.
  • Manufacturing scale and batch release compliance, especially for high-volume SKUs.

What market access friction blocks generic scale in Croatia?

  • Delays in reimbursement listing or price finalization.
  • Underestimated payer procurement dynamics.
  • Mismatch between generic SmPC and substitution expectations.

Where do licensing deals and settlements matter most for Croatia market entry?

Licensing and settlement arrangements can be decisive when:

  • Patents remain in force on key strengths or dosage forms.
  • Settlement terms include launch timing restrictions or supply limitations.
  • Brand holders monetize patent portfolios through structured agreements.

How do settlement terms typically influence timing in practice?

  • Restricting first launch date for a generic manufacturer even after regulatory approval.
  • Limiting affected SKUs, strengths, or indication claims.
  • Imposing marketing or distribution constraints.

What regulatory opportunities exist for new entrants beyond simple generics?

Non-traditional opportunities can include:

  • New formulations (if legally cleared), including improved dosing convenience.
  • Line extensions supported by separate clinical evidence and regulatory approvals.
  • Value-added medicines where local reimbursement rules allow distinct positioning.

When do reformulations create real market access in Croatia?

  • When payers accept differentiation and reimbursement criteria distinguish the product from the original generic equivalents.
  • When technical differentiation reduces substitution or prevents direct reference to lower-cost equivalents.

Which manufacturing and IP barriers are most likely to block generic or biosimilar entry in Croatia?

IP barriers

  • Active SPCs.
  • Formulation and process claims.
  • Second medical use or dosing regimen patents.

Manufacturing barriers

  • Bioequivalence readiness for difficult formulations (narrow therapeutic index drugs, complex release profiles).
  • Batch consistency across scale-up.
  • Analytical method comparability and validated test systems.

How does Croatia compare with neighboring EU markets for branded and generic strategy?

Croatia tends to be:

  • Lower in absolute revenue but meaningful for revenue diversification within EU footprints.
  • More payer-governed, with reimbursement and price controls often dominating commercial performance.
  • Operationally similar to EU member authorization standards, while reimbursement governance can create distinct launch economics.

What is the regional “learning curve” advantage?

  • EU dossier standards reduce regulatory friction for entrants with established compliance systems.
  • The main differentiator becomes local reimbursement execution and pricing strategy, not authorization chemistry.

Key commercial scenarios for branded and generic companies in Croatia

Branded sponsor scenario

  • Entry succeeds when reimbursement listing is secured and defended through lifecycle management.
  • Post-generic entry performance depends on substitution rules, payer restriction of indications, and price containment strategy.

Generic/biosimilar sponsor scenario

  • Revenue is sensitive to timing of reimbursement listing and price level.
  • Scale requires operational execution and proactive payer engagement to convert regulatory clearance into reimbursed utilization.

Key Takeaways

  • Croatia’s branded vs generic outcome is driven more by reimbursement positioning, price resets, and substitution governance than by EU regulatory approval alone.
  • Generic and biosimilar entry is constrained by enforceable patent families, especially SPCs, formulation/process claims, and indication-specific use protections.
  • Branded opportunities exist where reimbursement can be secured and defended via differentiation, restricted indication scope, or lifecycle strategies that survive reference pricing and substitution.
  • The highest risk for generics and biosimilars is not regulatory approval but commercial timing: reimbursement listing delays, price compression, and litigation-driven market access restrictions.

FAQs

  1. Does Croatia allow automatic generic substitution at the pharmacy level, and how does that affect pricing?
  2. How do Croatian reimbursement reference pricing rules impact the launch economics of new generics after branded exclusivity ends?
  3. What patent types most often block generic entry in EU markets, and how should that be mapped for Croatia strategy?
  4. Do biosimilar tender and procurement practices in Croatia accelerate switching after approval, or do they slow adoption?
  5. What dossier quality issues most commonly delay generic approvals in the EU framework that Croatia follows?

References

  1. European Medicines Agency. (n.d.). Guidelines and regulatory frameworks for generic and biosimilar medicines. EMA.
  2. European Commission. (n.d.). EU pharmaceutical legislation on data protection and market exclusivity. European Commission.
  3. Croatian health authorities. (n.d.). National pricing and reimbursement frameworks for medicinal products. Croatia public sources.

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