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Last Updated: April 17, 2021

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LYRICA Drug Profile

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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.

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Drug patent expirations by year for LYRICA
Drug Prices for LYRICA

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Drug Sales Revenue Trends for LYRICA

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Recent Clinical Trials for LYRICA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
CAMC Health SystemPhase 4
Vanderbilt University Medical CenterPhase 4
Zagazig UniversityN/A

See all LYRICA clinical trials

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

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

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