Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Medtronic
Dow
Johnson and Johnson
Merck
McKesson

Last Updated: May 26, 2022

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. 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.

  Sign up for a Free Trial

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
UpJohn US 1 LLCPhase 4
Mylan Inc.Phase 4
CAMC Health SystemPhase 4

See all LYRICA clinical trials

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

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

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

Serving leading biopharmaceutical companies globally:

Merck
Express Scripts
McKesson
Colorcon
Boehringer Ingelheim
Johnson and Johnson

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.