Claim Your New User Special: Get your second month free ▶ Second Month Free

Serving leading biopharmaceutical companies globally:

AstraZeneca
Merck
McKinsey
McKesson
Mallinckrodt
Dow

Last Updated: May 27, 2022

LYRICA CR Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

When do Lyrica Cr patents expire, and when can generic versions of Lyrica Cr launch?

Lyrica Cr is a drug marketed by Upjohn and is included in one NDA. There are three patents protecting this drug and two Paragraph IV challenges.

This drug has thirty-seven patent family members in thirty-three countries.

The generic ingredient in LYRICA CR 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 Cr

A generic version of LYRICA CR was approved as pregabalin by ALEMBIC PHARMS LTD on July 19th, 2019.

  Try it Free

Summary for LYRICA CR
International Patents:37
US Patents:3
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 2
Clinical Trials: 153
Formulation / Manufacturing:see details
Drug Prices: Drug price information for LYRICA CR
What excipients (inactive ingredients) are in LYRICA CR?LYRICA CR excipients list
DailyMed Link:LYRICA CR at DailyMed
Drug patent expirations by year for LYRICA CR
Drug Prices for LYRICA CR

See drug prices for LYRICA CR

Recent Clinical Trials for LYRICA CR

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

SponsorPhase
Mylan Inc.Phase 4
UpJohn US 1 LLCPhase 4
Vanderbilt University Medical CenterPhase 4

See all LYRICA CR clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for LYRICA CR
Paragraph IV (Patent) Challenges for LYRICA CR
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LYRICA CR Extended-release Tablets pregabalin 82.5 mg and 165 mg 209501 1 2018-02-02
LYRICA CR Extended-release Tablets pregabalin 330 mg 209501 1 2018-01-29

US Patents and Regulatory Information for LYRICA CR

LYRICA CR is protected by three US patents.

Patents protecting LYRICA CR

Solid pharmaceutical compositions containing pregabalin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Solid pharmaceutical compositions containing pregabalin
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Solid pharmaceutical compositions containing pregabalin
Patent Number: See Plans and Pricing
Patent 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 CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-001 Oct 11, 2017 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Upjohn LYRICA CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-003 Oct 11, 2017 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y 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 CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-003 Oct 11, 2017 AB RX Yes Yes See Plans and Pricing See Plans and Pricing Y 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

International Patents for LYRICA CR

When does loss-of-exclusivity occur for LYRICA CR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 8175
Estimated Expiration: See Plans and Pricing

Australia

Patent: 06310217
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0618211
Estimated Expiration: See Plans and Pricing

Canada

Patent: 28200
Estimated Expiration: See Plans and Pricing

China

Patent: 1330907
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 50
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 15009
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 45186
Estimated Expiration: See Plans and Pricing

Dominican Republic

Patent: 006000241
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 088422
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 2377
Estimated Expiration: See Plans and Pricing

Patent: 0800931
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 45186
Estimated Expiration: See Plans and Pricing

Guatemala

Patent: 0600474
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 26394
Estimated Expiration: See Plans and Pricing

Israel

Patent: 0827
Estimated Expiration: See Plans and Pricing

Japan

Patent: 34610
Estimated Expiration: See Plans and Pricing

Patent: 09514847
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 482
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 135
Estimated Expiration: See Plans and Pricing

Netherlands

Patent: 00281
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 7414
Estimated Expiration: See Plans and Pricing

Norway

Patent: 081816
Estimated Expiration: See Plans and Pricing

Peru

Patent: 070693
Estimated Expiration: See Plans and Pricing

Poland

Patent: 45186
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 45186
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 080181
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 45186
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0803115
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1012533
Estimated Expiration: See Plans and Pricing

Patent: 080059427
Estimated Expiration: See Plans and Pricing

Spain

Patent: 49231
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 30080
Estimated Expiration: See Plans and Pricing

Patent: 0803831
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 08194
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 890
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Country Patent Number Title Estimated Expiration
Israel 190827 PHARMACEUTICAL COMPOSITION COMPRISING PREGABALIN AND THE USE OF THE PHARMACEUTICAL COMPOSITION IN THE MANUFACTURE OF A MEDICAMENT See Plans and Pricing
Hungary 9702482 See Plans and Pricing
Norway 20081816 See Plans and Pricing
Denmark 0641330 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LYRICA CR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0641330 SPC/GB04/034 United Kingdom See Plans and Pricing 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 CR 2004 00036 Denmark See Plans and Pricing PRODUCT NAME: PREGABALIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/04/279/001-025 20040706
0641330 C300164 Netherlands See Plans and Pricing PRODUCT NAME: PREGABALINE, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/04/279/001 20040706
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:

Baxter
Medtronic
Dow
Express Scripts
McKesson
Harvard Business School

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.