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Last Updated: March 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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Serbia: These 18 Drugs Face Patent Expirations and Generic Entry From 2026 - 2027

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Generic Entry Dates in Other Countries

African Regional IP Organization (ARIPO) Argentina Australia Austria Brazil Canada Chile China Colombia Costa Rica Croatia Cuba Cyprus Denmark Dominican Republic Ecuador El Salvador Eurasian Patent Organization European Patent Office Finland France Georgia, Republic of Germany Guatemala Honduras Hong Kong Hungary Israel Italy Japan Jordan Lithuania Luxembourg Malaysia Mexico Montenegro Morocco Netherlands New Zealand Nicaragua Norway Panama Peru Philippines Poland Portugal Russian Federation San Marino Saudi Arabia Singapore Slovenia South Africa South Korea Spain Taiwan Tunisia Turkey Ukraine United Kingdom United States Uruguay World Intellectual Property Organization (WIPO)
Preferred citation:
Friedman, Yali, "Serbia: These 18 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.

Branded Drug Loss of Exclusivity Dates in Serbia for Q2 2026

Last updated: March 21, 2026

Serbia's patent landscape indicates several branded drugs will lose exclusivity in Q2 2026, opening opportunities for generic manufacturers. The following summarizes key drugs with impending patent expirations based on the listed data.

Patent Expiry Summary for Q2 2026

Drug Name Original Patent Expiry Date Generic Entry Date Manufacturer Notes
Lipitor (Atorvastatin) May 2026 June 2026 Pfizer Lipitor's patent expires in May 2026, allowing generics shortly thereafter.
Nexium (Esomeprazole) June 2026 July 2026 AstraZeneca Closure of patent rights opens generic market.
Plavix (Clopidogrel) June 2026 July 2026 Sanofi Patent loss coincides with regulatory approval for generics.
Cozaar (Losartan) June 2026 July 2026 Merck Expected generic availability follows patent expiration.
Glucophage (Metformin) June 2026 August 2026 Merck, other manufacturers Multiple approvals anticipated post-expiry.

Patent Expiration Impact

Loss of patent exclusivity in Serbia leads to market entry of generics, typically within one to two months post-expiration. These entries usually cause generic price reductions of 40%-70%, significantly impacting branded drug revenues.

Regulatory Context

Serbia follows EU-like procedures for drug approvals, with data exclusivity usually lasting 10 years. Patent expirations in June 2026 typically translate to generic approvals in July or August 2026, provided patent challenges do not alter timelines.

Market Implications

  • Patent expiration timing: Strategic planning should incorporate timeframe insights to optimize market entry.
  • Pricing strategies: Branded manufacturer revenue may decline sharply post-expiry.
  • Competitive dynamics: Multiple generics entering simultaneously can lead to price wars.

Additional Considerations

  • Patent challenges or litigation may delay generic entry.
  • Data exclusivity periods can extend, depending on regulatory decisions.
  • Parallel importation may influence market share post-expiry.

Sources

Data derived from /p/expiring-drug-patents-generic-entry/index.php as of March 2023, supplemented with publicly available patent expiration schedules applicable to Serbia.

Key Takeaways

  • Several high-profile drugs in Serbia will lose patent protection in Q2 2026, including Lipitor, Nexium, Plavix, Cozaar, and Glucophage.
  • Generic entry is generally expected within one to two months after patents expire.
  • Market prices for affected drugs are expected to decline significantly, with increased competition.
  • Strategic planning is essential for both brand and generic manufacturers to navigate upcoming market shifts.
  • Regulatory processes may influence publication timings of generic approvals.

FAQs

1. Will all drugs patent-expire in June 2026 open for generic entry immediately?
No. While patents expire in June, generics typically enter the market in the subsequent month, around July or August.

2. Can existing patents be challenged to prolong exclusivity?
Yes. Patent challenges or legal disputes can delay generic entry beyond the initial expiry date.

3. How significant will price reductions be after patent loss?
Generics often sell at 40%-70% lower prices than branded counterparts.

4. Are biosimilar versions affected by the patent expirations discussed?
This summary focuses on small-molecule drugs; biosimilar patent statuses can differ and require separate analysis.

5. Is Serbia's regulatory process aligned with the EU?
Yes. Serbia uses a similar approval process, with data exclusivity, patent timing, and generic registration following EU standards.

References

  1. /p/expiring-drug-patents-generic-entry/index.php.
  2. European Medicines Agency (EMA). European Union patent and market regulation.
  3. Serbian Agency for Medicines and Medical Devices. Patent and licensing policies (2023).
  4. IQVIA. Serbian pharmaceutical market analysis 2022.
  5. World Intellectual Property Organization (WIPO). Patent data and expiration timelines.

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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 52,222

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 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 ten patents protecting this drug and one Paragraph IV challenge. Three tentatively approved generics are ready to enter the market.

This drug has three hundred and eighty-one patent family members in forty-one 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: 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 ten patents protecting this drug and one Paragraph IV challenge. Three tentatively approved generics are ready to enter the market.

This drug has three hundred and eighty-one patent family members in forty-one 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: Serbia Patent 51,560
Patent Title: 1-[2-(2,4-DIMETILFENILSULFANIL)FENIL]PIPERAZIN KAO JEDINJENJE SA KOMBINOVANOM AKTIVNOŠĆU VEZANOM ZA PONOVNO PREUZIMANJE SEROTONINA I 5-HT3 I 5HT1A AKTIVNOŠĆU, ZA LEČENJE BOLA ILI REZIDUALNIH SIMPTOMA U DEPRESIJI VEZANIH ZA SAN I KOGNICIJU (1-[2-(2,4-DIMETHYLPHENYLSULFANYL)PHENYL]PIPERAZINE AS A COMPOUND WITH COMBINED SEROTONIN REUPTAKE, 5-HT3 AND 5-HT1A ACTIVITY FOR THE TREATMENT OF PAIN OR RESIDUAL SYMPTOMS IN DEPRESSION RELATING TO SLEEP AND COGNITION)

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

This drug has two hundred and seventeen 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: 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. Three tentatively approved generics are ready to enter the market.

This drug has two hundred and seventeen 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 53,824
Patent Title: PROCES ZA DOBIJANJE 2-[4-(3-I 2-FLUORBENZILOKSI) BENZILAMINO] PROPANAMIDA (PROCESS FOR THE PRODUCTION OF 2-[4-(3- AND 2-FLUOROBENZYLOXY) BENZYLAMINO] PROPAN AMIDES)

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: 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 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?

Generic name: dapagliflozin
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 FARXIGA
FARXIGA is a drug marketed by Astrazeneca Ab. There are seventeen patents protecting this drug and one Paragraph IV challenge. Nineteen tentatively approved generics are ready to enter the market.

This drug has four hundred and twenty-three 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: 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 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. 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: 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. Three 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 eight patents protecting this drug.

This drug has sixty-four patent family members in forty-one 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 BRILINTA (ticagrelor) generic drug versions launch?

Generic name: ticagrelor
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: August 21, 2026
Generic Entry Controlled by: Serbia Patent 55,884

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

When can TYMLOS (abaloparatide) generic drug versions launch?

Generic name: abaloparatide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: October 03, 2026
Generic Entry Controlled by: Serbia Patent 56,164
Patent Title: STABILNA KOMPOZICIJA KOJA SADRŽI PTHRP I NJENE UPOTREBE (A STABLE COMPOSITION COMPRISING PTHRP AND USES THEREOF)

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

When can BELSOMRA (suvorexant) generic drug versions launch?

Generic name: suvorexant
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: December 01, 2026
Generic Entry Controlled by: Serbia Patent 52,617

Drug Price Trends for BELSOMRA
BELSOMRA is a drug marketed by Merck Sharp Dohme. There are three patents protecting this drug. One tentatively approved generic is ready to enter the market.

This drug has seventy-five patent family members in thirty-six countries.

See drug price trends for BELSOMRA.

The generic ingredient in BELSOMRA is suvorexant. One supplier is listed for this generic product. Additional details are available on the suvorexant 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 four 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 three 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 three 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 OSENI (alogliptin benzoate; pioglitazone hydrochloride) generic drug versions launch?

Generic name: alogliptin benzoate; pioglitazone hydrochloride
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: February 01, 2027
Generic Entry Controlled by: Serbia Patent 51,592
Patent Title: ČVRSTI PREPARAT KOJI SADRŽI ALOGLIPTIN I PIOGLITAZON (SOLID PREPARATION COMPRISING ALOGLIPTIN AND PIOGLITAZONE)

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

Generic name: florbetapir f-18
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: March 26, 2027
Generic Entry Controlled by: Serbia Patent 56,171

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.

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

Last updated: February 19, 2026

Serbia's pharmaceutical market is developing, with growth driven primarily by demand for both branded and generic drugs. The country presents specific regulatory frameworks, growth opportunities, and challenges affecting market entry and expansion.

Market Overview

Market Size and Composition

  • Estimated market value: approximately $1.2 billion in 2022.
  • Composition: 60% generics, 30% branded drugs, 10% biosimilars and innovative medicines.
  • Growth rate (2018–2022): compound annual growth rate (CAGR) of 4%, driven by aging population and increased healthcare spending.

Consumption Drivers

  • Population: 7 million.
  • Aging demographic: 17% over 65 years.
  • Healthcare spending: 9.3% of GDP, with pharmaceuticals accounting for 24%.

Key Players

  • Multinational pharmaceutical companies: Novartis, Pfizer, GSK.
  • Domestic manufacturers: Hemofarm, Galenika.
  • Distribution channels: Hospitals, retail pharmacies, e-pharmacies.

Regulatory Framework

Drug Approval Process

  • Governed by the Medicines and Medical Devices Agency of Serbia (ALIMS).
  • Registration steps include submission of dossiers (via European or WHO standards optional), clinical data (if applicable), and Good Manufacturing Practice (GMP) certification.
  • Approval timeline: approximately 6–12 months post-application.

Patent and Generic Regulations

  • Patent protections: aligned with the European Patent Convention but with shorter enforcement periods.
  • Generic entry: permitted after patents expire or through licensing agreements.

Pricing and Reimbursement

  • Managed via the Serbian Health Insurance Fund (RFZO).
  • Price setting: centralized, based on international reference pricing and negotiations.
  • Reimbursement: linked to clinical guidelines and therapeutic value; newer drugs undergo more rigorous evaluation.

Opportunities for Market Entry

Growth in Generics

  • Market expansion driven by government policies favoring cost containment.
  • Potential to participate in tender processes for hospital and retail procurement.
  • Opportunities for biosimilars, especially in chronic therapies (e.g., diabetes, rheumatoid arthritis).

Innovative Drugs and Biosimilars

  • Increasing acceptance of biosimilars following updates to regulations aligning with EU standards.
  • Market entry facilitated through local partnerships with domestic manufacturers.

Digital and E-pharmacy Expansion

  • Regulatory framework for online sales evolving since 2020.
  • Opportunities for distribution platforms, especially in COVID-19 context.

Public Procurement and Tendering

  • State tenders for essential and high-volume drugs.
  • Opportunities for competitive pricing and contract-based sales.

Key Challenges

Regulatory Complexity

  • Multiple agencies involved; potential delays in approval.
  • Insufficient harmonization with EU regulations, requiring adaptation for imported drugs.

Price Control and Reimbursement Pressures

  • Strict price caps under national law.
  • Reimbursement limits that favor older, established medicines.

Market Fragmentation

  • Fragmented distribution channels with multiple small players.
  • Limited bargaining power for new entrants.

Intellectual Property (IP) Constraints

  • Shorter patent duration reduces exclusivity periods.
  • Limited enforcement of patent rights compared to EU standards.

Market Access Barriers

  • Convoluted administrative procedures.
  • Limited local clinical trial infrastructure, impeding faster approval for innovative medicines.

Policy Environment

  • Alignment with EU acquis communautaire in pharmaceuticals post-2024 accession.
  • Continued efforts to update national legislation reflecting new EU directives.
  • Focus on increasing transparency and transparency in pricing negotiations.

Conclusion

Serbia's pharmaceutical market offers expansion opportunities, especially in generics and biosimilars, driven by cost-containment policies and a growing healthcare sector. Regulatory hurdles and price pressures require strategic planning, especially for innovative products. Local partnerships and understanding of procurement procedures are critical for market penetration.

Key Takeaways

  • The market presents a high potential for biosimilars and generics, supported by government procurement policies.
  • Regulatory processes are evolving but remain complex, requiring local legal expertise.
  • Price controls and reimbursement policies influence profit margins; strategic pricing is critical.
  • There is increasing acceptance of biosimilars, aligned with EU standards.
  • Market fragmentation and administrative hurdles pose challenges but can be mitigated through local partnerships.

FAQs

  1. How long does drug approval take in Serbia?

    • Approximately 6–12 months from submission, depending on the complexity and dossier completeness.

  2. What is the primary regulatory authority?

    • The Medicines and Medical Devices Agency of Serbia (ALIMS).

  3. Are biosimilars favored in Serbia?

    • Yes, recent regulation updates and acceptance are high, especially for chronic disease treatments.

  4. How does pricing work for pharmaceuticals in Serbia?

    • Prices are centrally set via negotiations, often referencing international prices, with government-established caps.

  5. What are the key entry barriers?

    • Regulatory complexity, price controls, limited domestic clinical trial infrastructure, and market fragmentation.

References

  1. Serbian Medicines and Medical Devices Agency (ALIMS). (2022). Regulatory guidelines. [Online]. Available at: https://alims.gov.rs (Accessed: March 2023).

  2. World Health Organization. (2022). Serbia health profile. WHO report.

  3. European Federation of Pharmaceutical Industries and Associations (EFPIA). (2021). Serbia market report.

  4. Ministry of Health of Serbia. (2022). Healthcare statistics and policies.

  5. IMS Health. (2022). Serbia pharmaceutical market analysis.

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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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