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LYRICA Drug Profile
» See Plans and Pricing
When do Lyrica patents expire, and what generic alternatives are available?
Lyrica is a drug marketed by Pfizer and is included in three NDAs. There are three patents protecting this drug and six Paragraph IV challenges.
The generic ingredient in LYRICA is pregabalin. There are forty-one drug master file entries for this compound. Thirty-four suppliers are listed for this compound. Additional details are available on the pregabalin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Lyrica
A generic version of LYRICA was approved as pregabalin by ALEMBIC PHARMS LTD on July 19th, 2019.
Summary for LYRICA
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 3 |
| Suppliers / Packagers: | 11 |
| Bulk Api Vendors: | 90 |
| Clinical Trials: | 95 |
| Patent Applications: | 4,692 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for LYRICA |
| Drug Sales Revenues: | Drug sales revenues for LYRICA |
| What excipients (inactive ingredients) are in LYRICA? | LYRICA excipients list |
| DailyMed Link: | LYRICA at DailyMed |
Recent Clinical Trials for LYRICA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| CAMC Health System | Phase 4 |
| Vanderbilt University Medical Center | Phase 4 |
| Zagazig University | N/A |
Paragraph IV (Patent) Challenges for LYRICA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| LYRICA | SOLUTION;ORAL | pregabalin | 022488 | 2010-05-19 |
| LYRICA | CAPSULE;ORAL | pregabalin | 021446 | 2008-12-30 |
US Patents and Regulatory Information for LYRICA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pfizer | LYRICA | pregabalin | SOLUTION;ORAL | 022488-001 | Jan 4, 2010 | AA | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Pfizer | LYRICA | pregabalin | CAPSULE;ORAL | 021446-007 | Dec 30, 2004 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Pfizer | LYRICA CR | pregabalin | TABLET, EXTENDED RELEASE;ORAL | 209501-001 | Oct 11, 2017 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Pfizer | LYRICA CR | pregabalin | TABLET, EXTENDED RELEASE;ORAL | 209501-003 | Oct 11, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Pfizer | LYRICA | pregabalin | SOLUTION;ORAL | 022488-001 | Jan 4, 2010 | AA | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Pfizer | LYRICA CR | pregabalin | TABLET, EXTENDED RELEASE;ORAL | 209501-001 | Oct 11, 2017 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for LYRICA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pfizer | LYRICA | pregabalin | CAPSULE;ORAL | 021446-003 | Dec 30, 2004 | Start Trial | Start Trial |
| Pfizer | LYRICA | pregabalin | CAPSULE;ORAL | 021446-001 | Dec 30, 2004 | Start Trial | Start Trial |
| Pfizer | LYRICA | pregabalin | CAPSULE;ORAL | 021446-004 | Dec 30, 2004 | Start Trial | Start Trial |
| Pfizer | LYRICA | pregabalin | CAPSULE;ORAL | 021446-002 | Dec 30, 2004 | Start Trial | Start Trial |
| Pfizer | LYRICA | pregabalin | CAPSULE;ORAL | 021446-006 | Dec 30, 2004 | Start Trial | Start Trial |
| Pfizer | LYRICA | pregabalin | CAPSULE;ORAL | 021446-008 | Dec 30, 2004 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for LYRICA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Austria | 241351 | Start Trial |
| European Patent Office | 0934061 | Start Trial |
| Hong Kong | 1011022 | Start Trial |
| Denmark | 0641330 | Start Trial |
| Japan | 3856816 | Start Trial |
| Germany | 69722426 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for LYRICA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0641330 | 300164 | Netherlands | Start Trial | 300164, 20130518, EXPIRES: 20180517 |
| 0641330 | CA 2004 00036 | Denmark | Start Trial | |
| 0641330 | 27/2004 | Austria | Start Trial | PRODUCT NAME: PREGABALIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; REGISTRATION NO/DATE: EU/1/04/279/001 - EU/1/04/279/025 20040706 |
| 0641330 | SPC016/2004 | Ireland | Start Trial | SPC016/2004: 20050803, EXPIRES: 20180517 |
| 0641330 | 2004C/022 | Belgium | Start Trial | PRODUCT NAME: PREGABALIN; REGISTRATION NO/DATE: EU/1/04/279/001 20040708 |
| 0641330 | C300164 | Netherlands | Start Trial | PRODUCT NAME: PREGABALINE, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/04/279/001 20040706 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
