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Details for Generic Name: pregabalin

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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-three patent family members in thirty countries.

There are twenty-nine drug master file entries for pregabalin. Eight suppliers are listed for this compound. There are nine 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 list57
Therapeutic Class:Anticonvulsants

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

A Randomized Double-Blind Study Testing the Effects of Pregabalin on Diabetic Neuropathy
Status: Completed Condition: Diabetic Neuropathy

PharmacofMRI of Anxiolytic Medications (Pregabalin)
Status: Completed Condition: Anxiety Disorders

Role of Pregabalin in Treatment of Post-Op Pain in Fracture Patients
Status: Completed Condition: Post-operative Pain

Pregabalin and Orofacial Neuropathic Pain
Status: Terminated Condition: Neuropathic Pain; Orofacial Pain

Pregabalin, Celecoxib, Total Knee Arthroplasty and Intrathecal Morphine
Status: Completed Condition: Postoperative Pain Management; Total Knee Arthroplasty

Pregabalin on Interleukin-6 Levels in Living Donor Kidney
Status: Completed Condition: Pain

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
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, 2004RXNo6,197,819<disabled>YY <disabled>
Pf Prism Cv
LYRICA
pregabalin
SOLUTION;ORAL022488-001Jan 4, 2010RXYes6,197,819<disabled>YY <disabled>
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-001Dec 30, 2004RXNo6,197,819<disabled>YY <disabled>
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Expired Orange Book Patents for Generic Ingredient: pregabalin

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-005Dec 30, 20045,563,175<disabled>
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-001Dec 30, 20045,563,175<disabled>
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-006Dec 30, 20045,563,175<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
5,563,175 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>
6,525,096 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 Publication Date
Japan2004238398Aug 26, 2004
World Intellectual Property Organization (WIPO)9323383Nov 25, 1993
Mexico9302970May 31, 1994
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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