DrugPatentWatch Database Preview
LYRICA Drug Profile
Email this page to a colleague
» See Plans and PricingWhen do Lyrica patents expire, and what generic alternatives are available?
Lyrica is a drug marketed by Pf Prism Cv 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-one suppliers are listed for this compound. Additional details are available on the pregabalin profile page.
US ANDA 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
Recent Clinical Trials for LYRICA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| The Emili Sagol Creative Arts Therapies Research Center | N/A |
| University of Pennsylvania | Phase 2 |
| University of Missouri-Columbia | Phase 2/Phase 3 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pf Prism Cv | LYRICA | pregabalin | SOLUTION;ORAL | 022488-001 | Jan 4, 2010 | AA | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Pf Prism Cv | LYRICA | pregabalin | CAPSULE;ORAL | 021446-007 | Dec 30, 2004 | AB | RX | Yes | No | Start Trial | Start Trial | Start Trial | |||
| Pf Prism Cv | 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 |
|---|---|---|---|---|---|---|---|
| Pf Prism Cv | LYRICA | pregabalin | CAPSULE;ORAL | 021446-002 | Dec 30, 2004 | Start Trial | Start Trial |
| Pf Prism Cv | LYRICA | pregabalin | CAPSULE;ORAL | 021446-001 | Dec 30, 2004 | Start Trial | Start Trial |
| Pf Prism Cv | LYRICA | pregabalin | CAPSULE;ORAL | 021446-007 | 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 |
|---|---|---|
| Australia | 4379493 | Start Trial |
| New Zealand | 253459 | Start Trial |
| Portugal | 641330 | 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 | SPC016/2004 | Ireland | Start Trial | SPC016/2004: 20050803, EXPIRES: 20180517 |
| 0641330 | 91112 | Luxembourg | Start Trial | 91112, EXPIRES: 20180518 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
