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Pregabalin - Generic Drug Details

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Pregabalin is the generic ingredient in one branded drug marketed by Pf Prism Cv and is included in two NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

There are twenty-nine drug master file entries for pregabalin. Eleven suppliers are listed for this compound. There are fifteen tentative approvals for this compound.

Summary for Generic Name: pregabalin

Tradenames:1
Patents:3
Applicants:1
NDAs:2
Drug Master File Entries: see list29
Suppliers / Packaging: see list11
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details

Tentative approvals for PREGABALIN

Applicant Application No. Form Dosage
<disabled><disabled>CAPSULE; ORAL25MG
<disabled><disabled>CAPSULE; ORAL225MG
<disabled><disabled>CAPSULE; ORAL50MG

Clinical Trials for: pregabalin

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;ORAL021446-002Dec 30, 2004RXNo6,001,876<disabled>Y <disabled>
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-002Dec 30, 2004RXNoRE41920<disabled> <disabled>
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-008Dec 30, 2004RXYes6,001,876<disabled>Y <disabled>
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Expired Orange Book Patents for Generic Ingredient: pregabalin

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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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Non-Orange Book Patents for Generic Ingredient: pregabalin

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>
5,684,189 GABA and L-glutamic acid analogs for antiseizure treatment<disabled in preview>
5,847,151 Gaba and L-glutamic acid analogs for antiseizure treatment<disabled in preview>
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International Patent Family for Ingredient: pregabalin

Country Document Number Estimated Expiration
Canada2255652<disabled in preview>
China1094757<disabled in preview>
Australia3602497<disabled in preview>
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Supplementary Protection Certificates for Tradename: PREGABALIN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C016/2004Ireland<disabled>SPC016/2004: 20050803, EXPIRES: 20180517
00164Netherlands<disabled>PRODUCT NAME: PREGABALINE, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/04/279/001 20040706
0164Netherlands<disabled>300164, 20130518, EXPIRES: 20180517
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