LYRICA Drug Patent Profile
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When do Lyrica patents expire, and what generic alternatives are available?
Lyrica is a drug marketed by Upjohn and is included in three NDAs. There are three patents protecting this drug and two Paragraph IV challenges.
The generic ingredient in LYRICA 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
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 |
Finished Product Suppliers / Packagers: | 9 |
Raw Ingredient (Bulk) Api Vendors: | 92 |
Clinical Trials: | 153 |
Patent Applications: | 5,413 |
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 |
---|---|
UpJohn US 1 LLC | Phase 4 |
Mylan Inc. | Phase 4 |
CAMC Health System | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for LYRICA
Paragraph IV (Patent) Challenges for LYRICA
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
LYRICA | Oral Solution | pregabalin | 20 mg/mL | 022488 | 2010-05-19 | |
LYRICA | Capsules | pregabalin | 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg | 021446 | 2008-12-30 |
US Patents and Regulatory Information for LYRICA
LYRICA is protected by zero US patents and two FDA Regulatory Exclusivities.
FDA Regulatory Exclusivity protecting LYRICA
NEW PATIENT POPULATION
Exclusivity Expiration: See Plans and Pricing
PEDIATRIC EXCLUSIVITY
Exclusivity 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 | pregabalin | CAPSULE;ORAL | 021446-001 | Dec 30, 2004 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
Upjohn | LYRICA | pregabalin | SOLUTION;ORAL | 022488-001 | Jan 4, 2010 | AA | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | 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 | pregabalin | CAPSULE;ORAL | 021446-004 | Dec 30, 2004 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | 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 |
Expired US Patents for LYRICA
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Upjohn | LYRICA | pregabalin | CAPSULE;ORAL | 021446-004 | Dec 30, 2004 | See Plans and Pricing | See Plans and Pricing |
Upjohn | LYRICA | pregabalin | CAPSULE;ORAL | 021446-002 | Dec 30, 2004 | See Plans and Pricing | See Plans and Pricing |
Upjohn | LYRICA | pregabalin | CAPSULE;ORAL | 021446-001 | Dec 30, 2004 | See Plans and Pricing | See Plans and Pricing |
Upjohn | LYRICA | pregabalin | SOLUTION;ORAL | 022488-001 | Jan 4, 2010 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for LYRICA
See the table below for patents covering LYRICA around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 4297814 | See Plans and Pricing | |
Finland | 945426 | See Plans and Pricing | |
Japan | 3856816 | See Plans and Pricing | |
Australia | 9137091 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LYRICA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0641330 | CA 2004 00036 | Denmark | See Plans and Pricing | |
0934061 | PA2004017 | Lithuania | See Plans and Pricing | PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RûGðTIS) |
0641330 | SPC016/2004 | Ireland | See Plans and Pricing | SPC016/2004: 20050803, EXPIRES: 20180517 |
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 |