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Last Updated: June 14, 2025

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Croatia: These 14 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026

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Preferred citation:
Friedman, Yali, "Croatia: These 14 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026" DrugPatentWatch.com thinkBiotech, 2025 www.drugpatentwatch.com/p/expiring-drug-patents-generic-entry/.
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These estimated drug patent expiration dates and generic entry opportunity dates are calculated from analysis of known patents covering drugs. Many factors can influence early or late generic entry. This information is provided as a rough estimate of generic entry potential and should not be used as an independent source. The methodology is described in this blog post.
When can OLYSIO (simeprevir sodium) generic drug versions launch?

Generic name: simeprevir sodium
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 29, 2025
Generic Entry Controlled by: Croatia Patent P20110237

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

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

See drug price trends for OLYSIO.

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

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

Generic name: simeprevir sodium
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 29, 2025
Generic Entry Controlled by: Croatia Patent P20151326

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

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

See drug price trends for OLYSIO.

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

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

Generic name: pancrelipase (amylase;lipase;protease)
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 15, 2025
Generic Entry Controlled by: Croatia Patent P20100269

CREON is a drug marketed by

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

See drug price trends for CREON.

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

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

Generic name: sacubitril; valsartan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 09, 2025
Generic Entry Controlled by: Croatia Patent P20140274

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

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

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

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

Generic name: sacubitril; valsartan
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 09, 2025
Generic Entry Controlled by: Croatia Patent P20201605

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

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

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

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

Generic name: selumetinib sulfate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 21, 2025
Generic Entry Controlled by: Croatia Patent P20130663

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

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

See drug price trends for KOSELUGO.

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

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

Generic name: diazoxide choline
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: January 05, 2026
Generic Entry Controlled by: Croatia Patent P20120005

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

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

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

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

Generic name: amlodipine besylate; perindopril arginine
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 28, 2026
Generic Entry Controlled by: Croatia Patent P20160644

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

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

The generic ingredient in PRESTALIA is amlodipine besylate; perindopril arginine. There are fifty drug master file entries for this API. Additional details are available on the amlodipine besylate; perindopril arginine profile page.

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

Generic name: florbetapir f-18
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 30, 2026
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.

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

Generic name: florbetapir f-18
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 30, 2026
Generic Entry Controlled by: Croatia Patent P20170857

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.

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 TRADJENTA (linagliptin) generic drug versions launch?

Generic name: linagliptin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 04, 2026
Generic Entry Controlled by: Croatia Patent P20100507

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

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

See drug price trends for TRADJENTA.

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

When can TRADJENTA (linagliptin) generic drug versions launch?

Generic name: linagliptin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 04, 2026
Generic Entry Controlled by: Croatia Patent P20150003

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

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

See drug price trends for TRADJENTA.

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

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

Generic name: vortioxetine hydrobromide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 16, 2026
Generic Entry Controlled by: Croatia Patent P20110058

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

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

See drug price trends for TRINTELLIX.

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

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

Generic name: vortioxetine hydrobromide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 16, 2026
Generic Entry Controlled by: Croatia Patent P20120173

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

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

See drug price trends for TRINTELLIX.

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

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

Generic name: safinamide mesylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2026
Generic Entry Controlled by: 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 XADAGO (safinamide mesylate) generic drug versions launch?

Generic name: safinamide mesylate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 19, 2026
Generic Entry Controlled by: Croatia Patent P20161456

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 BYDUREON (exenatide synthetic) generic drug versions launch?

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

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

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

See drug price trends for BYDUREON.

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

When can FARXIGA (dapagliflozin) generic drug versions launch?

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

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

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

See drug price trends for FARXIGA.

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

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

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

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

This drug has three hundred and thirteen 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 RASUVO (methotrexate) generic drug versions launch?

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. Four suppliers are listed for this generic product. Additional details are available on the methotrexate profile page.

Market Analysis and Financial Projection

Croatia's pharmaceutical market presents a dynamic landscape for both branded and generic drugs, shaped by evolving regulations and market demands. Here's a structured assessment:

Market Overview

  • Branded Drugs: Represent 58% of total pharmaceutical revenues[13], with international companies like Pfizer and Sobi increasing investments in production facilities[9]. Patent-protected drugs benefit from extended "8+2+1" data exclusivity periods (8 years data + 2 years market + 1 year for new indications)[2], delaying generic competition.
  • Generic Drugs: Dominate 65% of pharmacy prescriptions by volume but only 27% of total drug spending[10]. Local manufacturers like Pliva (Teva Group) control 35% of market value and 50% by volume[5].

Regulatory Opportunities

  1. EU Harmonization:

    • Adoption of EU pharmacovigilance and counterfeiting directives streamlines market access[2].
    • Simplified authorization procedures for EU-approved drugs reduce delays (e.g., biosimilars approved by EMA gain faster HALMED approval)[11].

  2. Cost-Saving Reforms:

    • Internal Reference Pricing (IRP) at ATC Level III-V (vs. Level V) could save €54.7 million annually if optimized[1][4].
    • Automatic inclusion of generics on reimbursement lists post-HALMED approval may save HRK 700 million/year (€93 million)[9][10].

  3. Export Growth:

    • Pharmaceutical exports grew to HRK 8.4 billion (€1.1B) in 2021[9], driven by Croatia’s strategic position in Central Europe and eurozone integration[9].

  4. Medicinal Cannabis:

    • 2019 amendments allow licensed firms to cultivate low-THC cannabis, reducing import dependency[14].

Market Challenges

  1. Administrative Delays:

    • Generic approval takes 1–2 years due to HZZO reimbursement listing bottlenecks[10].
    • Hospital physicians show lower adoption of generics compared to GPs, citing familiarity gaps with biosimilars[10].

  2. Debt and Pricing Pressures:

    • Healthcare debt reached HRK 6.1 billion (€871M) in 2022, prompting stricter reimbursement controls[9].
    • ERP (External Reference Pricing) benchmarks against high-price countries like Italy and France, capping branded drug margins[6].

  3. Innovation vs. Affordability:

    • Extended data exclusivity delays generics but risks increasing out-of-pocket costs for patients[2][5].
    • Hospital budgets prioritize cost containment, limiting access to newer therapies[9][13].

Strategic Recommendations

For Generics/Biosimilars:

  • Accelerate HZZO listing processes via automated systems[10].
  • Implement physician education programs to boost hospital adoption[10].

For Branded Drugs:

  • Leverage Croatia’s 7.6% CAGR export growth (2022–2026)[9] to offset domestic pricing pressures.
  • Explore risk-sharing agreements with HZZO for high-cost therapies.

Regulatory Outlook:
Croatia’s alignment with EU norms enhances investor confidence but requires balancing IP protections with affordability. Upcoming reforms targeting debt reduction (e.g., faster generic substitution) could save €1B annually if fully implemented[10].

"The process of harmonizing national legislation with that of the EU will make doing business in Croatia easier for pharmaceutical companies." [2]

Key Statistics

Metric Value (2022–2023) Source
Total Pharma Market Size HRK 7.6B (€1.18B) [5]
Generic Share (Volume) 65% [10]
Biosimilar Market Share 13% (2019) [10]
Pharma Export Growth (2021) 4.5% YoY [9]
Projected Export CAGR (2022–26) 12.2% (USD terms) [9]

Croatia’s regulatory shifts and market dynamics position it as a gateway for EU expansion, though stakeholders must navigate pricing austerity and bureaucratic inertia to unlock growth.

References

  1. https://gabi-journal.net/pharmaceutical-pricing-in-croatia-a-comparison-of-ordinances-in-2013-versus-2009-and-their-potential-savings-to-provide-future-guidance.html
  2. https://www.spglobal.com/marketintelligence/en/mi/country-industry-forecasting.html?id=1065975528
  3. https://www.oecd.org/content/dam/oecd/en/publications/reports/2019/06/regulatory-policy-in-croatia_139ea066/b1c44413-en.pdf
  4. https://gabi-journal.net/wp-content/uploads/GJ-2015-2-p79-89-OriginalResearch-Brkicic.pdf
  5. https://documents1.worldbank.org/curated/en/646201593414252693/pdf/Croatia-Value-for-Money-in-Spending-on-Pharmaceuticals-Draft-Policy-Note.pdf
  6. https://www.pharmtech.com/view/croatia-pharma-and-corruption
  7. https://www.statista.com/outlook/hmo/pharmacies/prescription-drugs/croatia
  8. http://neuron.mefst.hr/docs/CMJ/issues/2010/51/2/CMJ_51(2)_TOMIC_20401952.pdf
  9. https://www.fitchsolutions.com/bmi/pharmaceuticals/croatia-will-become-more-attractive-destination-international-drugmaker-investment-14-09-2022
  10. https://total-croatia-news.com/lifestyle/croatian-market-5/
  11. https://pmc.ncbi.nlm.nih.gov/articles/PMC2859415/
  12. https://www.ibisworld.com/croatia/industry/pharmaceutical-product-preparations-manufacturing/200041/
  13. https://total-croatia-news.com/news/business/croatian-pharmaceutical-industry-depends-on-generic-drugs/
  14. https://www.wolftheiss.com/insights/liberalization-of-cultivation-and-production-of-medicinal-cannabis-in-croatia/
  15. https://repozitorij.efzg.unizg.hr/islandora/object/efzg:4420/datastream/PDF/view
Last updated: 2025-03-21

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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