You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: June 13, 2024

LYRICA Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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. Fifty-two 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.

  Sign Up

Drug patent expirations by year for LYRICA
Drug Prices for LYRICA

See drug prices for LYRICA

Drug Sales Revenue Trends for LYRICA

See drug sales revenues for LYRICA

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
Mylan Inc.Phase 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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Upjohn LYRICA CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-003 Oct 11, 2017 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Upjohn LYRICA pregabalin CAPSULE;ORAL 021446-007 Dec 30, 2004 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Upjohn LYRICA pregabalin CAPSULE;ORAL 021446-004 Dec 30, 2004 AB RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Upjohn LYRICA CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-001 Oct 11, 2017 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Upjohn LYRICA pregabalin CAPSULE;ORAL 021446-008 Dec 30, 2004 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 021446-001 Dec 30, 2004 ⤷  Sign Up ⤷  Sign Up
Upjohn LYRICA pregabalin CAPSULE;ORAL 021446-006 Dec 30, 2004 ⤷  Sign Up ⤷  Sign Up
Upjohn LYRICA pregabalin CAPSULE;ORAL 021446-003 Dec 30, 2004 ⤷  Sign Up ⤷  Sign Up
Upjohn LYRICA pregabalin SOLUTION;ORAL 022488-001 Jan 4, 2010 ⤷  Sign Up ⤷  Sign Up
Upjohn LYRICA pregabalin CAPSULE;ORAL 021446-007 Dec 30, 2004 ⤷  Sign Up ⤷  Sign Up
Upjohn LYRICA pregabalin CAPSULE;ORAL 021446-008 Dec 30, 2004 ⤷  Sign Up ⤷  Sign Up
>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
Upjohn EESV Lyrica pregabalin EMEA/H/C/000546
Neuropathic painLyrica is indicated for the treatment of peripheral and central neuropathic pain in adults.EpilepsyLyrica is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.Generalised anxiety disorderLyrica is indicated for the treatment of generalised anxiety disorder (GAD) in adults.
Authorised no no no 2004-07-05
Sandoz GmbH Pregabalin Sandoz GmbH pregabalin EMEA/H/C/004070
EpilepsyPregabalin Sandoz GmbH is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation.Generalised Anxiety DisorderPregabalin Sandoz GmbH is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.
Withdrawn yes no no 2015-06-19
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for LYRICA

See the table below for patents covering LYRICA around the world.

Country Patent Number Title Estimated Expiration
Cuba 22850 ISOBUTILGABA Y SUS DERIVADOS PARA EL TRATAMIENTO DEL DOLOR ⤷  Sign Up
South Korea 20000068015 ⤷  Sign Up
Japan H07508288 ⤷  Sign Up
Japan 4297814 ⤷  Sign Up
Japan 3856816 ⤷  Sign Up
Russian Federation 94046105 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LYRICA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0934061 PA2004017 Lithuania ⤷  Sign Up PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RûGðTIS)
0641330 SPC/GB04/034 United Kingdom ⤷  Sign Up PRODUCT NAME: PREGABALIN (S-(+)-4-AMINO-3(2-METHYLPROPYL)BUTANOIC ACID) OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACTIVE SALT.; REGISTERED: UK EU/1/04/279/001 20040706; UK EU/1/04/279/002 20040706; UK EU/1/04/279/003 20040706; UK EU/1/04/279/004 20040706; UK EU/1/04/279/005 20040706; UK EU/1/04/279/006 20040706; UK EU/1/04/279/025 20040706; UK EU/1/04/279/019 20040706; UK EU/1/04/279/020 20040706; UK EU/1/04/279/021 20040706; UK EU/1/04/279/022 20040706; UK EU/1/04/279/023 20040706; UK EU/1/04/279/024 20040706; UK EU/1/04/279/013 20040706; UK EU/1/04/279/014 20040706; UK EU/1/04/279/015 20040706; UK EU/1/04/279/016 20040706; UK EU/1/04/279/017 20040706; UK EU/1/04/279/018 20040706; UK EU/
0641330 SPC016/2004 Ireland ⤷  Sign Up SPC016/2004: 20050803, EXPIRES: 20180517
0641330 91112 Luxembourg ⤷  Sign Up 91112, EXPIRES: 20180518
0934061 PA2004017,C0934061 Lithuania ⤷  Sign Up PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RUGSTIS); REGISTRATION NO/DATE: EU/1/04/279/001-025 20040725
0641330 C00641330/01 Switzerland ⤷  Sign Up FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.