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Last Updated: April 25, 2025

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Montenegro: These 6 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026

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Preferred citation:
Friedman, Yali, "Montenegro: These 6 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 XTANDI (enzalutamide) generic drug versions launch?

Generic name: enzalutamide
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 13, 2025
Generic Entry Controlled by: Montenegro Patent 1,992
Patent Title: JEDINJENJE DIARILHIDANTOINA (DIARYLHYDANTOIN COMPOUNDS)

XTANDI is a drug marketed by Astellas. There are five patents protecting this drug and one Paragraph IV challenge. Two tentatively approved generics are ready to enter the market.

This drug has one hundred and ninety-one patent family members in thirty-five countries. There has been litigation on patents covering XTANDI

See drug price trends for XTANDI.

The generic ingredient in XTANDI is enzalutamide. There are nine drug master file entries for this API. One supplier is listed for this generic product. Additional details are available on the enzalutamide 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: Montenegro Patent 1,231
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 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: Montenegro Patent 2,415
Patent Title: Intermedijari za pripremu makrocikličkih 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: Montenegro Patent 482
Patent Title: ČVRSTE FARMACEUTSKE KOMPOZICIJE KOJE SADRŽE PREGABALIN SREDSTVO ZA FORMIRANJE MATRIKSA I SREDSTVO ZA BUBRENJE (SOLID ORAL PHARMACEUTICAL COMPOSITIONS FOR ONCE DAILY DOSING 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 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: Montenegro Patent 2,456
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 TRADJENTA (linagliptin) generic drug versions launch?

Generic name: linagliptin
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: May 04, 2026
Generic Entry Controlled by: Montenegro Patent 1,170
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. 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. 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: Montenegro Patent 1,941
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. 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. Three suppliers are listed for this generic product. Additional details are available on the linagliptin profile page.

When can FARYDAK (panobinostat lactate) generic drug versions launch?

Generic name: panobinostat lactate
DrugPatentWatch® Estimated Key Patent Expiration / Generic Entry Date: June 12, 2026
Generic Entry Controlled by: Montenegro Patent 529
Patent Title: POLIMORFI N-HIDROKSI-3-[4-[[[2-(-METIL-1H-INDOL-3-IL)ETIL]AMINO]FENIL]-2E-2-PROPENAMIDA (POLYMORPHS OF N-HYDROXY-3-[4-[[[2-(2-METHYL-1H-INDOL-3-YL)ETHYL]AMINO]METHYL]PHENYL]-2E-2-PROPENAMIDE)

FARYDAK is a drug marketed by Secura. There are two patents protecting this drug.

This drug has sixty-eight patent family members in forty countries. There has been litigation on patents covering FARYDAK

See drug price trends for FARYDAK.

The generic ingredient in FARYDAK is panobinostat lactate. There is one drug master file entry for this API. Additional details are available on the panobinostat lactate profile page.

Market Analysis and Financial Projection

Montenegro's pharmaceutical market is navigating a complex landscape shaped by EU integration efforts, evolving regulatory frameworks, and competing priorities between branded and generic drugs. With a population of 600,000 and a prescription drug market valued at approximately €85 million (2020), the country faces unique challenges and opportunities in balancing affordability with innovation[18][7].


Market Dynamics: Branded vs. Generic Drugs

Branded Drug Market

  • Growth Drivers: Chronic diseases like cancer (28,809 new cases in 2022) and cardiovascular conditions are increasing demand for branded therapies[2]. Foreign investments, such as Pfizer's production plant in neighboring Croatia, signal growing regional interest in innovative medicines[2].
  • Market Barriers: Outdated reimbursement lists (last updated in 2011) limit access to newer branded drugs. Only 30% of the market is served by international companies, with local wholesalers dominating distribution[18][3].
  • Strategic Shifts: Montenegro's 2023 eurozone accession facilitates trade, potentially attracting more branded drugmakers. However, doctors often rely on imported therapies from Croatia/Serbia due to local availability gaps[18][9].

Generic Drug Market

  • Dominance: Generics control ~70% of the market, driven by cost containment policies and pooled procurement strategies that achieve up to 85% savings on high-volume drugs[14][18].
  • Advocacy: The Genezis Association (15 member companies) actively promotes generics, aiming to replicate Serbia's success in expanding affordable options[10].
  • Quality Assurance: New 2024 labeling regulations mandate QR codes and align generics with EU quality standards, boosting consumer confidence[5].

Regulatory Opportunities

  1. EU Alignment
    Montenegro's 2024 Working Arrangement with the EU Drugs Agency (EUDA) enables access to advanced monitoring tools and expertise. This strengthens pharmacovigilance systems and accelerates regulatory harmonization[1][4]. CALIMS (Montenegro's medicines agency) now uses EU-compliant online reporting forms for adverse drug reactions[6]. The Institute for Medicines (CInMED) prioritizes anti-counterfeiting measures through upgraded lab capabilities[11].

  2. Market Modernization
    Joining the eurozone (2023) reduces currency risks for investors. The 2022–2026 CInMED strategy emphasizes streamlined clinical trial approvals and enhanced post-market surveillance, creating clearer pathways for both generics and innovators[11][12].

  3. Public-Private Partnerships
    AmCham's Health Care Committee collaborates with the Ministry of Health to overhaul reimbursement processes, advocating for quarterly list updates instead of multi-year delays[3][8]. Pilot projects with pooled procurement (e.g., Tuzla Canton model) demonstrate 30–85% cost reductions for generics[14].


Regulatory Challenges

Issue Impact Source
Outdated Reimbursement Patients lack access to 65% of WHO Essential Medicines; approval timelines lag behind Croatia/Serbia by 12–18 months [3][8][10]
Transparency Gaps Inconsistent pricing rules and unpredictable policy changes deter foreign investment [3][14]
Resource Constraints CALIMS struggles with staffing shortages, delaying drug approvals and inspections [16][12]
Prescription Practices 36% of adults smoke (vs. 12% global average), driving preventable diseases and stretching limited healthcare budgets [18]

Strategic Recommendations

  1. Accelerate List Updates: Adopt Slovenia/Croatia's model of quarterly reimbursement list revisions to improve access[8].
  2. Boost Local Manufacturing: Leverage Montenegro's 5.36% pharma CAGR (2025–2030 projections) to incentivize API production facilities[17][2].
  3. Digital Integration: Expand CALIMS' electronic labeling mandate to encompass real-time supply chain tracking[5][11].

"Harmonizing our regulations with EU standards isn't just about compliance—it's about securing Montenegrins' right to world-class treatments."
– Danilo Šaranović, Interior Minister of Montenegro[1]


Key Takeaways

  • Generics dominate but face quality perception hurdles; branded drugs struggle with reimbursement delays.
  • EU integration offers tools for regulatory modernization but requires capacity building.
  • Urgent reforms needed in pricing transparency and list modernization to unlock growth.

FAQs
Q: How does Montenegro's drug approval timeline compare to the EU?
A: Typically 6–12 months longer due to resource constraints at CALIMS[12][16].

Q: What percentage of Montenegrins use imported medications?
A: ~40% for specialized therapies, primarily sourced from Serbia/Croatia[18][9].

Q: Are online pharmacy sales permitted?
A: No—prescription drugs are exclusively sold via licensed brick-and-mortar pharmacies[7][15].

Q: How does Montenegro combat counterfeit drugs?
A: CInMED operates a state lab for batch testing and partners with INTERPOL on cross-border operations[11].

Q: What tax incentives exist for pharma investors?
A: Reduced VAT (7%) for essential medicines, but broader incentives remain under discussion[14][17].

References

  1. https://www.euda.europa.eu/news/2024/eu-drugs-agency-signs-working-arrangement-montenegro_en
  2. https://www.mordorintelligence.com/industry-reports/croatia-pharmaceutical-market
  3. http://www.amcham.me/2014/11/on-the-road-to-improving-the-health-care-system-in-montenegro/
  4. https://www.euda.europa.eu/system/files/media/attachments/documents/11942/STRATEGY%20OF%20MONTENEGRO%20FOR%20THE%20PREVENTION%20OF%20DRUG%20ABUSE%202013-2020%20and%20the%20Action%20Plan%202013-20161.pdf
  5. https://www.marketsandata.com/industry-reports/vietnam-generic-drugs-market
  6. https://pmc.ncbi.nlm.nih.gov/articles/PMC6045893/
  7. https://www.statista.com/outlook/hmo/pharmacies/prescription-drugs/montenegro?currency=USD
  8. https://digital.net.me/storage/Hddwg8wl2QeqFHRSO541sGwnGyMzPSK6HlpfbwOA.pdf
  9. https://sunwave-group.com/montenegro-distribution/
  10. https://genezis.org/?journal-medical-the-genezis-association-established-a-representative-office-in-montenegro
  11. https://cinmed.me/wp-content/uploads/2023/02/Development-Strategy-of-the-Institute-2022-20026-00000003.pdf
  12. https://generisonline.com/pharmaceutical-regulations-in-montenegro-a-comprehensive-overview/
  13. https://www.drugpatentwatch.com/blog/regulatory-challenges-in-the-latin-american-generic-drug-market/
  14. https://openknowledge.worldbank.org/server/api/core/bitstreams/b1e66e46-4f4e-5fd9-9367-ea5578a62dde/content
  15. https://www.statista.com/outlook/hmo/pharmacies/prescription-drugs/montenegro
  16. https://um.fi/documents/385176/0/Support+to+the+Agency+for+Medicines+and+Medical+Devices+of+Montenegro+(CALIMS).pdf/1d6b88dd-3375-f0d0-4985-520c51aa08f7?t=1591883127755
  17. https://www.6wresearch.com/industry-report/montenegro-chemical-pharmaceutical-market
  18. https://www.yourpharmapartner.eu/central-eastern-europe/montenegro
  19. https://www.stellarmr.com/report/Generic-Drug-Market/1638

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