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Last Updated: July 12, 2020

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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 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.

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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

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SponsorPhase
The Emili Sagol Creative Arts Therapies Research CenterN/A
University of PennsylvaniaPhase 2
University of Missouri-ColumbiaPhase 2/Phase 3

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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

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

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Serving leading biopharmaceutical companies globally:

Merck
Express Scripts
McKesson
Colorcon
Boehringer Ingelheim
Johnson and Johnson

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