You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: July 18, 2025

Expiring Drug Patents Cheat Sheet
We analyse the patents covering drugs in 134 countries and quickly give you the likely loss-of-exclusivity/generic entry date

➤ Get the Full List

Serbia: These 9 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026

The content of this page is licensed under a Creative Commons Attribution 4.0 International License. Creative Commons License

Preferred citation:
Friedman, Yali, "Serbia: These 9 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026" DrugPatentWatch.com thinkBiotech, 2025 www.drugpatentwatch.com/p/expiring-drug-patents-generic-entry/.
Media collateral
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: Serbia Patent 54,473
Patent Title: INTERMEDIJARI ZA DOBIJANJE MAKROCIKLIČNIH INHIBITORA VIRUSA HEPATITISA C (INTERMEDIATES FOR THE PREPARATION OF MACROCYCLIC INHIBITORS OF HEPATITIS C VIRUS)

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

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

See drug price trends for OLYSIO.

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

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

Generic name: pregabalin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: November 02, 2025
Generic Entry Controlled by: Serbia Patent 20,080,181
Patent Title: ČVRSTE FARMACEUTSKE KOMPOZICIJE KOJE SADRŽE PREGABALIN SREDSTVO ZA FORMIRANJE MATRIKSA I SREDSTVO ZA BUBRENJE (SOLID PHARMACEUTICAL COMPOSITIONS CONTAINING PREGABALIN, A MATRIX FORMING AGENT AND A SWELLING AGENT)

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

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

See drug price trends for LYRICA CR.

The generic ingredient in LYRICA CR is pregabalin. There are forty-one drug master file entries for this API. Fifty-four suppliers are listed for this generic product. Additional details are available on the pregabalin 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: Serbia Patent 52,843
Patent Title: NOVA SO VODONIK SULFATA (NOVEL HYDROGEN SULFATE SALT)

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 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: Serbia Patent 54,754
Patent Title: KRISTALNI OBLIK ARGININSKE SOLI PERINDOPRILA, POSTUPAK NJENE PROIZVODNJE I FARMACEUTSKE SMEŠE KOJE JE SADRŽE (CRYSTALLINE FORM OF THE ARGININE SALT OF PERINDOPRIL, PROCESS FOR PREPARING IT, AND PHARMACEUTICAL COMPOSITIONS COMPRISING IT)

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: Serbia Patent 56,171
Patent Title: DERIVATI STIRILPIRIDINA I NJIHOVA UPOTREBA ZA VEZIVANJE I IMIDŽING AMILOIDNIH PLAKOVA (STYRYLPYRIDINE DERIVATIVES AND THEIR USE FOR BINDING AND IMAGING AMYLOID PLAQUES)

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 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: Serbia Patent 52,205
Patent Title: 1-[2-(2,4-DIMETILFENILSULFANIL)-FENIL]PIPERAZIN KAO JEDINJENJE SA KOMBINOVANOM AKTIVNOŠĆU PONOVNOG UZIMANJA SEROTONINA, 5-HT3 I 5-HT1A, ZA TRETMAN KOGNITIVNIH OŠTEĆENJA (1-[2-(2,4-DIMETHYLPHENYLSULFANYL)-PHENYL]PIPERAZINE AS A COMPOUND WITH COMBINED SEROTONIN REUPTAKE, 5-HT3 AND 5-HT1A ACTIVITY FOR THE TREATMENT OF COGNITIVE IMPAIRMENT)

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: Serbia Patent 55,464
Patent Title: 2-[4-(3- I 2 FLUORBENZILOKSI) BENZILAMINO] PROPANAMIDI VISOKOG STEPENA ČISTOĆE ZA UPOTREBU KAO LEKOVI I FARMACEUTSKI PREPARATI KOJI IH SADRŽE (HIGH PURITY DEGREE 2-[4-(3- AND 2-FLUOROBENZYLOXY)BENZYLAMINO]PROPANAMIDES FOR USE AS MEDICAMENTS AND PHARMACEUTICAL FORMULATIONS CONTAINING THEM)

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 RASUVO (methotrexate) generic drug versions launch?

Generic name: methotrexate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 21, 2026
Generic Entry Controlled by: Serbia Patent 51,688
Patent Title: KONCENTROVANI RASTVORI METOTREKSATA (CONCENTRATED METHOTREXATE SOLUTIONS)

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.

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

Generic name: simeprevir sodium
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: July 28, 2026
Generic Entry Controlled by: Serbia Patent 51,743
Patent Title: MAKROCIKLIČKI INHIBITORI VIRUSA HEPATITISA C (MACROCYCLIC INHIBITORS OF HEPATITIS C VIRUS)

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

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

See drug price trends for OLYSIO.

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

Market Analysis and Financial Projection

Last updated: March 19, 2025

The Serbian pharmaceutical market presents a dynamic landscape shaped by rapid growth, generic dominance, and evolving regulatory frameworks. With a market value reaching €1.85 billion in 2024 (11% annual growth), Serbia's sector is outpacing regional peers, driven by hospital channel expansion and oncology drug demand[1][7][15]. Below is a detailed assessment of market dynamics and regulatory considerations:


Market Structure and Growth Drivers

  • Generic dominance: Generics account for 70-80% of the Serbian market, with local manufacturers like Galenika and Hemofarm maintaining privileged status through streamlined reimbursement processes[3][8][15].
  • Innovative drug acceleration: The Rx original segment contributed 55% of recent growth (+€139M), particularly in antineoplastics (+€65.5M) and alimentary therapies[1][11].
  • Hospital sector surge: Hospital drug consumption doubled since 2021, now representing 42% of Rx market share, driven by cancer therapies and centralized procurement[1][8].
Key Therapy Areas Driving Growth Category 2024 Value (€M) Growth Contribution
Antineoplastics 540 +65.5M[1]
Alimentary Tract 329 +20M[1]
Nervous System 363 +8M[1]
Biologics 250 +49% CAGR[7]

Regulatory Landscape: Opportunities vs Challenges

Opportunities

  • EU-aligned registration: ALIMS (Serbian drug agency) now accepts EU dossiers and ICH guidelines, reducing approval timelines for compliant applicants[5][12].
  • Import diversification: 2024 legislative proposals aim to enable Russian/Chinese drug imports, particularly for antibiotics and oncology therapies[9].
  • Clinical trial reforms: December 2024 amendments allow private hospitals in all trial phases and recognize EMA decisions, attracting R&D investment[12].

Challenges

  • Reimbursement delays: Average 18-24 month lag for innovative drug inclusions on the Positive List[11][14].
  • Enforcement gaps: 40% of inspected pharmacies had unregistered medicines in 2023 due to understaffed regulatory bodies[4][8].
  • Shortage management: 68% of pharmacists report weekly generic shortages, exacerbated by parallel exports to EU markets[10].

Strategic Recommendations for Market Entry

For Generics Manufacturers

  • Leverage local serialization requirements (batch-level tracking) as market entry barrier[11]
  • Target shortage-prone categories:
    • Parenteral antibiotics (23% shortage rate)
    • Cardiovascular generics (17% price inflation)[10][15]

For Innovators

  • Utilize risk-sharing agreements with RFZO (National Health Fund), now covering 40+ innovative therapies[11][14]
  • Partner with hospital clusters for direct procurement pathways bypassing retail bottlenecks[1][8]

"Serbia's pharmaceutical evolution mirrors its EU accession journey – generics form the foundation, but innovation builds the future." [14]


Future Outlook to 2025

  • Market projection: €2.1B total value by 2025 (+6.7% CAGR), with biologics reaching 30% market share[7][11].
  • Regulatory milestones:
    • Q2 2025: New Medicines Act implementation
    • Q3 2025: Joint Serbia-Russia drug production initiatives[9]
    • Q4 2025: Digital prescription system rollout[12]

The Serbian market offers strategic value for companies adaptable to its hybrid regulatory environment – combining EU-aligned quality standards with Balkan-specific market access dynamics. Success requires balancing short-term generic opportunities with long-term innovative therapy investments.

References

  1. https://api.pks.rs/storage/assets/Serbian%20Pharma%20Market%20Overview%20Sep_2024.pdf
  2. https://pmc.ncbi.nlm.nih.gov/articles/PMC4479706/
  3. https://genezis.org/?pharmaboardroom-interview-ana-popovic
  4. https://ocindex.net/country/serbia
  5. https://omcmedical.com/serbia-drug-product-registration/
  6. https://www.europeanreview.org/wp/wp-content/uploads/905.pdf
  7. https://www.medis.com/hu/novice/podrobno/news/country-in-focus-serbia/
  8. https://openknowledge.worldbank.org/server/api/core/bitstreams/b1e66e46-4f4e-5fd9-9367-ea5578a62dde/content
  9. https://gxpnews.net/en/2024/03/serbia-may-amend-legislation-to-facilitate-the-importation-of-russian-pharmaceuticals/
  10. https://pmc.ncbi.nlm.nih.gov/articles/PMC8066253/
  11. https://www.medis.com/news/news-single/news/infected-with-enthusiasm-evolution-of-the-serbian-pharma-market/
  12. https://www.legal500.com/guides/chapter/serbia-life-sciences/
  13. https://www.frontiersin.org/journals/public-health/articles/10.3389/fpubh.2015.00150/full
  14. https://www.diplomacyandcommerce.rs/ksenija-purkovic-astrazenecas-commitment-to-healthcare-in-serbia/
  15. https://legacy.export.gov/article?id=Serbia-Pharmaceutical

More… ↓

⤷  Try for Free

DrugPatentWatch cited by CNN, NEJM, Nature Journals, and more …

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.