LYRICA CR Drug Patent Profile
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When do Lyrica Cr patents expire, and when can generic versions of Lyrica Cr launch?
Lyrica Cr is a drug marketed by Upjohn and is included in one NDA. There are three patents protecting this drug and two Paragraph IV challenges.
This drug has thirty-seven patent family members in thirty-three countries.
The generic ingredient in LYRICA CR is pregabalin. There are forty-one drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the pregabalin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Lyrica Cr
A generic version of LYRICA CR was approved as pregabalin by ALEMBIC PHARMS LTD on July 19th, 2019.
Summary for LYRICA CR
International Patents: | 37 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Clinical Trials: | 153 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for LYRICA CR |
What excipients (inactive ingredients) are in LYRICA CR? | LYRICA CR excipients list |
DailyMed Link: | LYRICA CR at DailyMed |


Recent Clinical Trials for LYRICA CR
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Mylan Inc. | Phase 4 |
UpJohn US 1 LLC | Phase 4 |
Vanderbilt University Medical Center | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for LYRICA CR
Paragraph IV (Patent) Challenges for LYRICA CR
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
LYRICA CR | Extended-release Tablets | pregabalin | 82.5 mg and 165 mg | 209501 | 1 | 2018-02-02 |
LYRICA CR | Extended-release Tablets | pregabalin | 330 mg | 209501 | 1 | 2018-01-29 |
US Patents and Regulatory Information for LYRICA CR
LYRICA CR is protected by three US patents.
Patents protecting LYRICA CR
Solid pharmaceutical compositions containing pregabalin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Solid pharmaceutical compositions containing pregabalin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Solid pharmaceutical compositions containing pregabalin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Upjohn | LYRICA CR | pregabalin | TABLET, EXTENDED RELEASE;ORAL | 209501-001 | Oct 11, 2017 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
Upjohn | LYRICA CR | pregabalin | TABLET, EXTENDED RELEASE;ORAL | 209501-003 | Oct 11, 2017 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
Upjohn | LYRICA CR | pregabalin | TABLET, EXTENDED RELEASE;ORAL | 209501-002 | Oct 11, 2017 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
Upjohn | LYRICA CR | pregabalin | TABLET, EXTENDED RELEASE;ORAL | 209501-003 | Oct 11, 2017 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for LYRICA CR
When does loss-of-exclusivity occur for LYRICA CR?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 8175
Estimated Expiration: See Plans and Pricing
Australia
Patent: 06310217
Estimated Expiration: See Plans and Pricing
Brazil
Patent: 0618211
Estimated Expiration: See Plans and Pricing
Canada
Patent: 28200
Estimated Expiration: See Plans and Pricing
China
Patent: 1330907
Estimated Expiration: See Plans and Pricing
Costa Rica
Patent: 50
Estimated Expiration: See Plans and Pricing
Cyprus
Patent: 15009
Estimated Expiration: See Plans and Pricing
Denmark
Patent: 45186
Estimated Expiration: See Plans and Pricing
Dominican Republic
Patent: 006000241
Estimated Expiration: See Plans and Pricing
Ecuador
Patent: 088422
Estimated Expiration: See Plans and Pricing
Eurasian Patent Organization
Patent: 2377
Estimated Expiration: See Plans and Pricing
Patent: 0800931
Estimated Expiration: See Plans and Pricing
European Patent Office
Patent: 45186
Estimated Expiration: See Plans and Pricing
Guatemala
Patent: 0600474
Estimated Expiration: See Plans and Pricing
Hong Kong
Patent: 26394
Estimated Expiration: See Plans and Pricing
Israel
Patent: 0827
Estimated Expiration: See Plans and Pricing
Japan
Patent: 34610
Estimated Expiration: See Plans and Pricing
Patent: 09514847
Estimated Expiration: See Plans and Pricing
Montenegro
Patent: 482
Estimated Expiration: See Plans and Pricing
Morocco
Patent: 135
Estimated Expiration: See Plans and Pricing
Netherlands
Patent: 00281
Estimated Expiration: See Plans and Pricing
New Zealand
Patent: 7414
Estimated Expiration: See Plans and Pricing
Norway
Patent: 081816
Estimated Expiration: See Plans and Pricing
Peru
Patent: 070693
Estimated Expiration: See Plans and Pricing
Poland
Patent: 45186
Estimated Expiration: See Plans and Pricing
Portugal
Patent: 45186
Estimated Expiration: See Plans and Pricing
Serbia
Patent: 080181
Estimated Expiration: See Plans and Pricing
Slovenia
Patent: 45186
Estimated Expiration: See Plans and Pricing
South Africa
Patent: 0803115
Estimated Expiration: See Plans and Pricing
South Korea
Patent: 1012533
Estimated Expiration: See Plans and Pricing
Patent: 080059427
Estimated Expiration: See Plans and Pricing
Spain
Patent: 49231
Estimated Expiration: See Plans and Pricing
Taiwan
Patent: 30080
Estimated Expiration: See Plans and Pricing
Patent: 0803831
Estimated Expiration: See Plans and Pricing
Tunisia
Patent: 08194
Estimated Expiration: See Plans and Pricing
Uruguay
Patent: 890
Estimated Expiration: See Plans and Pricing
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering LYRICA CR around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Israel | 190827 | PHARMACEUTICAL COMPOSITION COMPRISING PREGABALIN AND THE USE OF THE PHARMACEUTICAL COMPOSITION IN THE MANUFACTURE OF A MEDICAMENT | See Plans and Pricing |
Hungary | 9702482 | See Plans and Pricing | |
Norway | 20081816 | See Plans and Pricing | |
Denmark | 0641330 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LYRICA CR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0641330 | SPC/GB04/034 | United Kingdom | See Plans and Pricing | PRODUCT NAME: PREGABALIN (S-(+)-4-AMINO-3(2-METHYLPROPYL)BUTANOIC ACID) OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACTIVE SALT.; REGISTERED: UK EU/1/04/279/001 20040706; UK EU/1/04/279/002 20040706; UK EU/1/04/279/003 20040706; UK EU/1/04/279/004 20040706; UK EU/1/04/279/005 20040706; UK EU/1/04/279/006 20040706; UK EU/1/04/279/025 20040706; UK EU/1/04/279/019 20040706; UK EU/1/04/279/020 20040706; UK EU/1/04/279/021 20040706; UK EU/1/04/279/022 20040706; UK EU/1/04/279/023 20040706; UK EU/1/04/279/024 20040706; UK EU/1/04/279/013 20040706; UK EU/1/04/279/014 20040706; UK EU/1/04/279/015 20040706; UK EU/1/04/279/016 20040706; UK EU/1/04/279/017 20040706; UK EU/1/04/279/018 20040706; UK EU/ |
0641330 | CR 2004 00036 | Denmark | See Plans and Pricing | PRODUCT NAME: PREGABALIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/04/279/001-025 20040706 |
0641330 | C300164 | Netherlands | See Plans and Pricing | PRODUCT NAME: PREGABALINE, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/04/279/001 20040706 |
0934061 | PA2004017,C0934061 | Lithuania | See Plans and Pricing | PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RUGSTIS); REGISTRATION NO/DATE: EU/1/04/279/001-025 20040725 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |