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Last Updated: March 5, 2021

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LYRICA CR Drug 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 Pfizer and is included in one NDA. There are three patents protecting this drug and four 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-four suppliers are listed for this compound. Additional details are available on the pregabalin profile page.

US ANDA 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.

  Start Trial

Summary for LYRICA CR
International Patents:37
US Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: 2
Clinical Trials: 95
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
CAMC Health SystemPhase 4
Vanderbilt University Medical CenterPhase 4
Zagazig UniversityN/A

See all LYRICA CR clinical trials

Paragraph IV (Patent) Challenges for LYRICA CR
Tradename Dosage Ingredient NDA Submissiondate
LYRICA CR TABLET, EXTENDED RELEASE;ORAL pregabalin 209501 2018-02-02
LYRICA CR TABLET, EXTENDED RELEASE;ORAL pregabalin 209501 2018-01-29

US Patents and Regulatory Information for LYRICA CR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer LYRICA CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-001 Oct 11, 2017 RX Yes No   Start Trial   Start Trial Y   Start Trial
Pfizer LYRICA CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-002 Oct 11, 2017 RX Yes No   Start Trial   Start Trial Y   Start Trial
Pfizer LYRICA CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-001 Oct 11, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
Pfizer LYRICA CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-003 Oct 11, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Pfizer LYRICA CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-002 Oct 11, 2017 RX Yes No   Start Trial   Start Trial Y   Start Trial
Pfizer LYRICA CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-003 Oct 11, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for LYRICA CR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0641330 C300164 Netherlands   Start Trial PRODUCT NAME: PREGABALINE, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/04/279/001 20040706
0641330 SPC016/2004 Ireland   Start Trial SPC016/2004: 20050803, EXPIRES: 20180517
0641330 C00641330/01 Switzerland   Start Trial FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
0641330 SPC/GB04/034 United Kingdom   Start Trial 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 300164 Netherlands   Start Trial 300164, 20130518, EXPIRES: 20180517
0641330 CA 2004 00036 Denmark   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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