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. Forty-nine 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 on July 19th, 2019.
Summary for LYRICA CR
International Patents: | 37 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 95 |
Clinical Trials: | 157 |
Patent Applications: | 4,455 |
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 |
---|---|
Henry Ford Health System | Phase 4 |
An-Najah National University | Phase 2/Phase 3 |
UpJohn US 1 LLC | 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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Solid pharmaceutical compositions containing pregabalin
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Solid pharmaceutical compositions containing pregabalin
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Upjohn | LYRICA CR | pregabalin | TABLET, EXTENDED RELEASE;ORAL | 209501-003 | Oct 11, 2017 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Upjohn | LYRICA CR | pregabalin | TABLET, EXTENDED RELEASE;ORAL | 209501-002 | Oct 11, 2017 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
Upjohn | LYRICA CR | pregabalin | TABLET, EXTENDED RELEASE;ORAL | 209501-003 | Oct 11, 2017 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for LYRICA CR
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Zentiva k.s. | Pregabalin Zentiva k.s. | pregabalin | EMEA/H/C/004277 Neuropathic painPregabalin Zentiva k.s. is indicated for the treatment of peripheral and central neuropathic pain in adults.EpilepsyPregabalin Zentiva k.s. is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.Generalised anxiety disorderPregabalin Zentiva k.s. is indicated for the treatment of generalised anxiety disorder (GAD) in adults. |
Withdrawn | yes | no | no | 2017-02-27 | |
Zentiva, k.s. | Pregabalin Zentiva | pregabalin | EMEA/H/C/003900 Neuropathic pain, , , Pregabalin Zentiva is indicated for the treatment of peripheral and central neuropathic pain in adults., , , Epilepsy, , , Pregabalin Zentiva is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation., , , Generalised anxiety disorder, , , Pregabalin Zentiva is indicated for the treatment of generalised anxiety disorder (GAD) in adults., , |
Authorised | yes | no | no | 2015-07-17 | |
Mylan S.A.S. | Pregabalin Mylan Pharma | pregabalin | EMEA/H/C/003962 EpilepsyPregabalin Mylan Pharma is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.Generalised Anxiety DisorderPregabalin Mylan Pharma is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults. |
Withdrawn | yes | no | no | 2015-06-25 | |
Upjohn EESV | Pregabalin Pfizer | pregabalin | EMEA/H/C/003880 Neuropathic painPregabalin Pfizer is indicated for the treatment of peripheral and central neuropathic pain in adults.EpilepsyPregabalin Pfizer is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.Generalised Anxiety DisorderPregabalin Pfizer is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults. |
Authorised | no | no | no | 2014-04-10 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
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: ⤷ Try a Trial
Australia
Patent: 06310217
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0618211
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 28200
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1330907
Estimated Expiration: ⤷ Try a Trial
Costa Rica
Patent: 50
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 15009
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 45186
Estimated Expiration: ⤷ Try a Trial
Dominican Republic
Patent: 006000241
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 088422
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 2377
Estimated Expiration: ⤷ Try a Trial
Patent: 0800931
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 45186
Estimated Expiration: ⤷ Try a Trial
Guatemala
Patent: 0600474
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 26394
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 0827
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 34610
Estimated Expiration: ⤷ Try a Trial
Patent: 09514847
Estimated Expiration: ⤷ Try a Trial
Montenegro
Patent: 482
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 135
Estimated Expiration: ⤷ Try a Trial
Netherlands
Patent: 00281
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 7414
Estimated Expiration: ⤷ Try a Trial
Norway
Patent: 081816
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 070693
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 45186
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 45186
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 080181
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 45186
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 0803115
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1012533
Estimated Expiration: ⤷ Try a Trial
Patent: 080059427
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 49231
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 30080
Estimated Expiration: ⤷ Try a Trial
Patent: 0803831
Estimated Expiration: ⤷ Try a Trial
Tunisia
Patent: 08194
Estimated Expiration: ⤷ Try a Trial
Uruguay
Patent: 890
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
Netherlands | 2000281 | Vaste farmaceutische samenstellingen die pregabaline bevatten. | ⤷ Try a Trial |
Poland | 1945186 | ⤷ Try a Trial | |
Taiwan | I330080 | ⤷ Try a Trial | |
Spain | 2200184 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LYRICA CR
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0934061 | PA2004017 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RûGðTIS) |
0934061 | PA2004017,C0934061 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RUGSTIS); REGISTRATION NO/DATE: EU/1/04/279/001-025 20040725 |
0641330 | CA 2004 00036 | Denmark | ⤷ Try a Trial | |
0641330 | 2004C/022 | Belgium | ⤷ Try a Trial | PRODUCT NAME: PREGABALIN; REGISTRATION NO/DATE: EU/1/04/279/001 20040708 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |