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Last Updated: March 19, 2024

Lyrica Drug Patent Profile


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Which patents cover Lyrica, and when can generic versions of Lyrica launch?

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. Fifty-one 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 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
Henry Ford Health SystemPhase 4
An-Najah National UniversityPhase 2/Phase 3
UpJohn US 1 LLCPhase 4

See all Lyrica clinical trials

Paragraph IV (Patent) Challenges for LYRICA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LYRICA Oral Solution pregabalin 20 mg/mL 022488 1 2010-05-19
LYRICA Capsules pregabalin 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg 021446 8 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
Upjohn LYRICA pregabalin CAPSULE;ORAL 021446-001 Dec 30, 2004 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Upjohn LYRICA CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-003 Oct 11, 2017 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Upjohn LYRICA pregabalin CAPSULE;ORAL 021446-007 Dec 30, 2004 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Upjohn LYRICA pregabalin CAPSULE;ORAL 021446-004 Dec 30, 2004 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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
Upjohn LYRICA pregabalin CAPSULE;ORAL 021446-008 Dec 30, 2004 ⤷  Try a Trial ⤷  Try a Trial
Upjohn LYRICA pregabalin CAPSULE;ORAL 021446-001 Dec 30, 2004 ⤷  Try a Trial ⤷  Try a Trial
Upjohn LYRICA pregabalin CAPSULE;ORAL 021446-005 Dec 30, 2004 ⤷  Try a Trial ⤷  Try a Trial
Upjohn LYRICA pregabalin CAPSULE;ORAL 021446-006 Dec 30, 2004 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for Lyrica

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Zentiva k.s. Pregabalin Zentiva k.s. pregabalin EMEA/H/C/004277
Neuropathic painPregabalin Zentiva k.s. is indicated for the treatment of peripheral and central neuropathic pain in adults.EpilepsyPregabalin Zentiva k.s. is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.Generalised anxiety disorderPregabalin Zentiva k.s. is indicated for the treatment of generalised anxiety disorder (GAD) in adults.
Withdrawn yes no no 2017-02-27
Zentiva, k.s. Pregabalin Zentiva pregabalin EMEA/H/C/003900
Neuropathic pain, , , Pregabalin Zentiva is indicated for the treatment of peripheral and central neuropathic pain in adults., , , Epilepsy, , , Pregabalin Zentiva is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation., , , Generalised anxiety disorder, , , Pregabalin Zentiva is indicated for the treatment of generalised anxiety disorder (GAD) in adults., ,
Authorised yes no no 2015-07-17
Mylan S.A.S. Pregabalin Mylan Pharma pregabalin EMEA/H/C/003962
EpilepsyPregabalin Mylan Pharma is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.Generalised Anxiety DisorderPregabalin Mylan Pharma is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
Withdrawn yes no no 2015-06-25
Upjohn EESV Pregabalin Pfizer pregabalin EMEA/H/C/003880
Neuropathic painPregabalin Pfizer is indicated for the treatment of peripheral and central neuropathic pain in adults.EpilepsyPregabalin Pfizer is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.Generalised Anxiety DisorderPregabalin Pfizer is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
Authorised no no no 2014-04-10
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for Lyrica

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0641330 27/2004 Austria ⤷  Try a 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 CR 2004 00036 Denmark ⤷  Try a Trial PRODUCT NAME: PREGABALIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/04/279/001-025 20040706
0641330 2004C/022 Belgium ⤷  Try a Trial PRODUCT NAME: PREGABALIN; REGISTRATION NO/DATE: EU/1/04/279/001 20040708
0934061 PA2004017 Lithuania ⤷  Try a Trial PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RûGðTIS)
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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