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Last Updated: December 28, 2025

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Serbia: These 8 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026

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Preferred citation:
Friedman, Yali, "Serbia: These 8 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 TRADJENTA (linagliptin) generic drug versions launch?

Generic name: linagliptin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 04, 2026
Generic Entry Controlled by: Serbia Patent 51,466
Patent Title: FORMULACIJE DPP IV INHIBITORA (DPP IV INHIBITOR FORMULATIONS)

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

This drug has four hundred and eighty-six 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. Three 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: Serbia Patent 53,570
Patent Title: FORMULACIJE DPP IV INHIBITORA (DPP IV INHIBITOR FORMULATIONS)

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

This drug has four hundred and eighty-six 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. Three suppliers are listed for this generic product. Additional details are available on the linagliptin 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: Serbia Patent 53,638
Patent Title: KRISTALNI SOLVATI DERIVATA (1S)-1,5-ANHIDRO-1-C-(3-((FENIL) METIL) FENIL)-D-GLUCITOLA SA ALKOHOLIMA KAO INHIBITORI SGLT2 ZA TRETMAN DIJABETESA (CRYSTALLINE SOLVATES OF (1S)-1,5-ANHYDRO-1-C-(3-((PHENYL) METHYL) PHENYL)-D-GLUCITOL DERIVATIVES WITH ALCOHOLS AS SGLT2 INHIBITORS FOR THE TREATMENT OF DIABETES)

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 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.

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

Generic name: pregabalin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 23, 2026
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-six suppliers are listed for this generic product. Additional details are available on the pregabalin profile page.

When can INVOKAMET (canagliflozin; metformin hydrochloride) generic drug versions launch?

Generic name: canagliflozin; metformin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 04, 2026
Generic Entry Controlled by: Serbia Patent 53,274
Patent Title: KRISTALNI OBLIK 1-(β-D-GLUKOPIRANOZIL)-4-METIL-3-[5-(4-FLUORFENIL)-2-TIENILMETIL]BENZEN HEMIHIDRAT (CRYSTALLINE FORM OF 1- (SS-D-GLUCOPYRANOSYL) -4 -METHYL- 3- [5- (4 -FLUOROPHENYL) -2-THIENYLMETHYL]BENZENE HEMIHYDRATE)

Drug Price Trends for INVOKAMET
INVOKAMET is a drug marketed by Janssen Pharms. There are five patents protecting this drug and two Paragraph IV challenges.

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

See drug price trends for INVOKAMET.

The generic ingredient in INVOKAMET is canagliflozin; metformin hydrochloride. There are twenty-one drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the canagliflozin; metformin hydrochloride profile page.

When can INVOKAMET XR (canagliflozin; metformin hydrochloride) generic drug versions launch?

Generic name: canagliflozin; metformin hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 04, 2026
Generic Entry Controlled by: Serbia Patent 53,274
Patent Title: KRISTALNI OBLIK 1-(β-D-GLUKOPIRANOZIL)-4-METIL-3-[5-(4-FLUORFENIL)-2-TIENILMETIL]BENZEN HEMIHIDRAT (CRYSTALLINE FORM OF 1- (SS-D-GLUCOPYRANOSYL) -4 -METHYL- 3- [5- (4 -FLUOROPHENYL) -2-THIENYLMETHYL]BENZENE HEMIHYDRATE)

Drug Price Trends for INVOKAMET XR
INVOKAMET XR is a drug marketed by Janssen Pharms. There are four patents protecting this drug.

This drug has two hundred and twenty patent family members in forty-five countries. There has been litigation on patents covering INVOKAMET XR

See drug price trends for INVOKAMET XR.

The generic ingredient in INVOKAMET XR is canagliflozin; metformin hydrochloride. There are twenty-one drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the canagliflozin; metformin hydrochloride profile page.

When can INVOKANA (canagliflozin) generic drug versions launch?

Generic name: canagliflozin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 04, 2026
Generic Entry Controlled by: Serbia Patent 53,274
Patent Title: KRISTALNI OBLIK 1-(β-D-GLUKOPIRANOZIL)-4-METIL-3-[5-(4-FLUORFENIL)-2-TIENILMETIL]BENZEN HEMIHIDRAT (CRYSTALLINE FORM OF 1- (SS-D-GLUCOPYRANOSYL) -4 -METHYL- 3- [5- (4 -FLUOROPHENYL) -2-THIENYLMETHYL]BENZENE HEMIHYDRATE)

Drug Price Trends for INVOKANA
INVOKANA is a drug marketed by Janssen Pharms. There are four patents protecting this drug and one Paragraph IV challenge. Five tentatively approved generics are ready to enter the market.

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

See drug price trends for INVOKANA.

The generic ingredient in INVOKANA is canagliflozin. There are twenty-one drug master file entries for this API. Three suppliers are listed for this generic product. Additional details are available on the canagliflozin profile page.

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

Generic name: bedaquiline fumarate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 05, 2026
Generic Entry Controlled by: Serbia Patent 52,408
Patent Title: FUMARATNA SO (ALFA S, BETA R)-6-BROMO-ALFA-[2-(DIMETILAMINO)ETIL]-2-METOKSI-ALFA-1-NAFTALENIL-BETA-FENIL-3-KINOLINETANOLA (FUMARATE SALT OF (ALPHA S, BETA R)-6-BROMO-ALPHA-[2-(DIMETHYLAMINO)ETHYL]-2¬METHOXY-ALPHA-1-NAPHTHALENYL-BETA-PHENYL-3-QUlNOLINEETHANOL)

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.

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

Last updated: December 27, 2025

Executive Summary

Serbia's pharmaceutical sector presents significant growth opportunities driven by demographic factors, increasing healthcare expenditure, and the country's strategic position within the Balkans. The market is characterized by a substantial presence of both branded and generic drugs, with the latter increasingly penetrating the healthcare system due to cost-containment policies. This report provides a comprehensive assessment of Serbia's drug markets, highlighting regulatory frameworks, opportunities for market entry, and prevailing challenges, supported by recent data and policy shifts. It offers insights essential for pharmaceutical companies, investors, and stakeholders aiming to navigate Serbia’s complex regulatory environment and capitalize on market potential.

Overview of Serbia's Drug Market

Market Size and Composition

Metric 2022 Estimate Notes
Total pharmaceutical market value $1.2 billion USD Estimated (IQVIA, 2022[1])
Branded drugs share 45% Dominant in specialized sectors
Generic drugs share 52% Growing due to policy incentives
OTC segment 3% Niche but expanding

Serbia's drug market experienced a compound annual growth rate (CAGR) of approximately 4% from 2017-2022. The market is predominantly driven by imported medicines, with local manufacturing limited but expanding.

Market Trends

  • Shift toward generic drugs to reduce healthcare costs.
  • Rising demand for biologics and biosimilars.
  • Increased government focus on affordable medicine access.

Regulatory Landscape in Serbia

Key Regulatory Authorities

Authority Role Date Established
Agency for Medicines and Medical Devices of Serbia (ALIMS) Drug approval, licensing, post-market surveillance 2009[2]
Ministry of Health Policy formulation and healthcare regulation 2004

Approval Process

  • Registration Requirements: Submission of dossiers conforming to European Medicines Agency (EMA) standards, as Serbia aligns with Eurasian Economic Union (EAEU) regulations and reflects EU Good Manufacturing Practice (GMP) standards.
  • Timeline: Approximately 6-12 months for new drug approvals (varies by complexity).
  • Data Exclusivity: 10 years for originator products, aligned with EU standards.

Market Entry Regulations

Aspect Regulations Challenges
Pricing Negotiated with Ministry of Health based on external reference pricing Limited transparency, lengthy negotiations
Reimbursement Managed via the National Health Fund (FZO) Strict eligibility criteria, delayed reimbursements
Pharmacovigilance Mandatory reporting systems aligned with EU practices Infrastructure development ongoing

Opportunities in Serbia’s Pharmaceutical Sector

Growth Drivers

  • Cost-Containment Policies: Favor generic substitution and biosimilars, increasing demand.
  • Population Dynamics: Approx. 7 million inhabitants, aging population increasing demand for chronic disease treatments.
  • Regional Hub Potential: Strategic location for distribution to neighboring markets.
  • Local Manufacturing Expansion: Incentives to boost domestic production, reducing import dependency.

Key Market Segments

Segment Opportunities Challenges
Generics Entry via partnerships, licensing, or direct investment Price pressure, accreditation requirements
Biologics/Biosimilars High-growth potential due to patent expirations Complex registration, manufacturing standards
OTC Growing due to health awareness campaigns Market saturation, low margins
Innovative Drugs Entry at higher price tiers for specialty diseases Regulatory hurdles, reimbursement limits

Regulatory Incentives

  • Simplified registration pathways for medicines aligned with EU standards.
  • Potential tax incentives for local manufacturing.
  • Support from international trade agreements for market access.

Challenges in Serbia’s Pharmaceutical Market

Market Barriers

Barrier Description Impact
Price Regulations External reference pricing limits profit margins Discourages R&D investments
Bureaucracy Lengthy approval and licensing process Delays market entry
Reimbursement Delays Slow approval for inclusion in the positive list Reduced market uptake
Intellectual Property (IP) Enforcement inconsistencies Risks associated with patent infringement

Regulatory Challenges

  • Alignment with EU standards: Although Serbia is candidate for EU accession, full harmonization remains ongoing.
  • Data Exclusivity Violations: Risk of imitation by local manufacturers due to ambiguous enforcement.
  • GMP Compliance: Upgrading manufacturing facilities to meet EU standards entails high capital investments.

Economic and Political Factors

  • Currency fluctuations impact pricing strategies.
  • Political stability influences regulatory changes.
  • Income levels and healthcare funding limitations constrain affordability.

Strategic Approaches for Market Entry and Growth

Navigating Regulatory Frameworks

  • Engage early with ALIMS and Ministry of Health to understand evolving policies.
  • Leverage harmonization efforts aligned with EU and EAEU standards.
  • Ensure robust pharmacovigilance systems to maintain compliance.

Partnering and Local Manufacturing

  • Form partnerships with local distributors or contract manufacturing organizations.
  • Consider establishing local manufacturing units to benefit from incentives and reduce costs.
  • Invest in capacity building for biosimilars to meet technical standards.

Competitive Differentiation

  • Focus on high-quality generics and biosimilars to mitigate price erosion.
  • Develop targeted marketing strategies emphasizing efficacy, safety, and compliance.
  • Adopt digital tools for efficient supply chain and market access.

Comparative Analysis: Serbia vs. Neighboring Markets

Country Market Size (2022) Regulatory Stringency Generic Penetration Reimbursement Speed Major Challenges
Serbia $1.2B Moderate 52% Moderate Price regulation, infrastructure
Croatia $1.3B High 58% Fast Harmonization with EU
Bosnia & Herzegovina $0.7B Moderate 45% Slow Fragmented regulation
North Macedonia $0.6B Moderate 50% Moderate Market access barriers

FAQs

Q1: How does Serbia's alignment with EU pharmaceutical standards influence market entry?
A1: Serbia's adoption of EU GMP and pharmacovigilance standards streamlines approval processes for medicines compliant with these standards, facilitating easier market entry for European companies. However, full accession remains pending, requiring ongoing adaptation.

Q2: What are the main reimbursement challenges faced by pharmaceutical companies in Serbia?
A2: The National Health Fund applies strict criteria for inclusion in the positive list, often leading to delays and capped reimbursement prices, impacting profitability and market penetration.

Q3: Are biosimilars a viable entry point into Serbia’s pharmaceutical market?
A3: Yes. The country's focus on cost-effective treatments and patent expirations create opportunities for biosimilars, provided companies meet rigorous registration and manufacturing standards.

Q4: What intellectual property risks exist for foreign pharma entities operating in Serbia?
A4: Enforcement of IP rights is less stringent than in EU countries, raising risks of patent infringements. Companies should implement robust legal strategies and seek patent protection before market entry.

Q5: How do economic factors influence pharmaceutical pricing strategies in Serbia?
A5: Currency fluctuations and government price caps necessitate flexible pricing models. External reference pricing with neighboring countries further constrains profit margins.

Key Takeaways

  • Market Potential: Serbia’s pharmaceutical market is mature with a growing generics and biosimilars segment driven by cost policies and demographic shifts.
  • Regulatory Landscape: Aligns partially with EU standards, emphasizing the importance of early regulatory engagement and compliance.
  • Opportunities: Local manufacturing incentives, biosimilar growth, regional distribution hub status, and healthcare reforms offer strategic avenues.
  • Challenges: Price controls, bureaucratic delays, enforcement inconsistencies, and economic variables necessitate comprehensive risk management.
  • Strategic Recommendations: Engage early with regulators, leverage EU harmonization efforts, build local partnerships, and focus on high-quality, compliant products.

References

[1] IQVIA, 2022. Serbia Pharmaceuticals Market Report.
[2] Agency for Medicines and Medical Devices of Serbia (ALIMS), 2009. Official Regulatory Framework.

(Note: Additional data sources such as WHO reports, national policies, and industry analyses should be integrated for comprehensive decision-making.)

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Preferred Citation:

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