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LYRICA Drug Profile

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Lyrica is a drug marketed by Pf Prism Cv and is included in two NDAs. It is available from eleven suppliers. There are three patents protecting this drug and two Paragraph IV challenges.

This drug has sixty-five patent family members in thirty-one countries.

The generic ingredient in LYRICA is pregabalin. There are twenty-nine drug master file entries for this compound. Eleven suppliers are listed for this compound. There are fifteen tentative approvals for this compound. Additional details are available on the pregabalin profile page.

Summary for Tradename: LYRICA

Patents:3
Applicants:1
NDAs:2
Suppliers / Packagers: see list11

Clinical Trials for: LYRICA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-008Dec 30, 2004RXYes6,197,819<disabled>YY <disabled>
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-007Dec 30, 2004RXNo6,197,819<disabled>YY <disabled>
Pf Prism Cv
LYRICA
pregabalin
SOLUTION;ORAL022488-001Jan 4, 2010RXYes6,001,876<disabled>Y <disabled>
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Expired Patents for Tradename: LYRICA

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-004Dec 30, 20045,563,175<disabled>
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-006Dec 30, 20045,563,175<disabled>
Pf Prism Cv
LYRICA
pregabalin
SOLUTION;ORAL022488-001Jan 4, 20105,563,175<disabled>
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Paragraph IV activity for: LYRICA

Drugname Dosage Strength RLD Submissiondate
pregabalinOral Solution20 mg/mLLyrica5/19/2010
pregabalinCapsules25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mgLyrica12/30/2008

Non-Orange Book Patents for Tradename: LYRICA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,847,151 Gaba and L-glutamic acid analogs for antiseizure treatment<disabled in preview>
6,342,529 GABA and L-glutamic acid analogs for antiseizure treatment<disabled in preview>
6,262,120 GABA and L-glutamic acid analogs for antiseizure treatment<disabled in preview>
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International Patent Family for Tradename: LYRICA

Country Document Number Estimated Expiration
Germany69330949<disabled in preview>
HungaryT71522<disabled in preview>
Finland945426<disabled in preview>
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Supplementary Protection Certificates for Tradename: LYRICA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0164Netherlands<disabled>300164, 20130518, EXPIRES: 20180517
C/GB04/034United Kingdom<disabled>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/
C016/2004Ireland<disabled>SPC016/2004: 20050803, EXPIRES: 20180517
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