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
Montenegro: These 6 Drugs Face Patent Expirations and Generic Entry From 2025 - 2026
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Generic Entry Dates in Other Countries
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)
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)
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)
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.
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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.
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