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Last Updated: March 19, 2024

LYRICA CR Drug Patent Profile


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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. 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 Cr

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

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Summary for LYRICA CR
Drug patent expirations by year for LYRICA CR
Drug Prices for LYRICA CR

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Recent Clinical Trials for LYRICA CR

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 CR clinical trials

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Solid pharmaceutical compositions containing pregabalin
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Solid pharmaceutical compositions containing pregabalin
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  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
Upjohn LYRICA CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-001 Oct 11, 2017 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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 CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-002 Oct 11, 2017 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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 CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-001 Oct 11, 2017 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Upjohn LYRICA CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-001 Oct 11, 2017 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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

EU/EMA Drug Approvals for LYRICA CR

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 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: ⤷  Try a Trial

Australia

Patent: 06310217
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0618211
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 28200
Estimated Expiration: ⤷  Try a Trial

China

Patent: 1330907
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 50
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 15009
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 45186
Estimated Expiration: ⤷  Try a Trial

Dominican Republic

Patent: 006000241
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 088422
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 2377
Estimated Expiration: ⤷  Try a Trial

Patent: 0800931
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 45186
Estimated Expiration: ⤷  Try a Trial

Guatemala

Patent: 0600474
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 26394
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 0827
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 34610
Estimated Expiration: ⤷  Try a Trial

Patent: 09514847
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 482
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 135
Estimated Expiration: ⤷  Try a Trial

Netherlands

Patent: 00281
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 7414
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 081816
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 070693
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 45186
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 45186
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 080181
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 45186
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0803115
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1012533
Estimated Expiration: ⤷  Try a Trial

Patent: 080059427
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 49231
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 30080
Estimated Expiration: ⤷  Try a Trial

Patent: 0803831
Estimated Expiration: ⤷  Try a Trial

Tunisia

Patent: 08194
Estimated Expiration: ⤷  Try a Trial

Uruguay

Patent: 890
Estimated Expiration: ⤷  Try a Trial

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
Spain 2165857 ⤷  Try a Trial
New Zealand 332762 Isobutylgaba and its derivatives for the treatment of pain ⤷  Try a Trial
Taiwan 200803831 Solid pharmaceutical compositions containing pregabalin ⤷  Try a Trial
Slovakia 139594 GABA ANALOGS AND L-GLUTAMIC ACID AND METHOD OF THEIR PRODUCTION ⤷  Try a Trial
Morocco 30135 COMPOSITIONS PHARMACEUTIQUES SOLIDES CONTENANT DE LA PREGABALINE ⤷  Try a Trial
Poland 331325 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LYRICA CR

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)
0641330 300164 Netherlands ⤷  Try a Trial 300164, 20130518, EXPIRES: 20180517
0934061 PA2004017,C0934061 Lithuania ⤷  Try a Trial 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

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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.