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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;ORAL021446-003Dec 30, 20045,563,175<disabled>
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-001Dec 30, 20045,563,175<disabled>
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-005Dec 30, 20045,563,175<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
6,262,120 GABA and L-glutamic acid analogs for antiseizure treatment<disabled in preview>
6,414,024 GABA and L-glutamic acid analogs for antiseizure treatment<disabled in preview>
6,117,906 GABA and L-glutamic acid analogs for antiseizure treatment<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: LYRICA

Country Document Number Estimated Expiration
Australia677008<disabled in preview>
China1094757<disabled in preview>
Canada2134674<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: LYRICA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2004 00036Denmark<disabled>
2004017,C0934061Lithuania<disabled>PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RUGSTIS); REGISTRATION NO/DATE: EU/1/04/279/001-025 20040725
2004 00036Denmark<disabled>PRODUCT NAME: PREGABALIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/04/279/001-025 20040706
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