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Last Updated: June 6, 2020

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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 Pf Prism Cv 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-one 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

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
Pf Prism Cv LYRICA CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-001 Oct 11, 2017 RX Yes No   Start Trial   Start Trial Y   Start Trial
Pf Prism Cv LYRICA CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-002 Oct 11, 2017 RX Yes No   Start Trial   Start Trial Y   Start Trial
Pf Prism Cv LYRICA CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-001 Oct 11, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
Pf Prism Cv LYRICA CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-003 Oct 11, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Pf Prism Cv LYRICA CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-002 Oct 11, 2017 RX Yes No   Start Trial   Start Trial Y   Start Trial
Pf Prism Cv 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 SPC016/2004 Ireland   Start Trial SPC016/2004: 20050803, EXPIRES: 20180517
0641330 CA 2004 00036 Denmark   Start Trial
0641330 CR 2004 00036 Denmark   Start Trial PRODUCT NAME: PREGABALIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/04/279/001-025 20040706
0934061 PA2004017,C0934061 Lithuania   Start Trial PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RUGSTIS); REGISTRATION NO/DATE: EU/1/04/279/001-025 20040725
0641330 91112 Luxembourg   Start Trial 91112, EXPIRES: 20180518
0934061 PA2004017 Lithuania   Start Trial PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RûGðTIS)
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Medtronic
Dow
Express Scripts
McKesson
Harvard Business School

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