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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-eight 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

Drug Master File Entries: see list28
Suppliers / Packaging: see list57
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details

Tentative approvals for PREGABALIN

Applicant Application No. Form Dosage
<disabled><disabled>CAPSULE; ORAL200MG
<disabled><disabled>CAPSULE; ORAL25MG
<disabled><disabled>CAPSULE; ORAL225MG

Clinical Trials for: pregabalin

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

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

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

Efficacy of Pregabalin on Chronic Cough
Status: Recruiting Condition: Cough

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

Courtesy of
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
CAPSULE;ORAL021446-004Dec 30, 2004RXNo6,197,819<disabled>YY <disabled>
Pf Prism Cv
CAPSULE;ORAL021446-007Dec 30, 2004RXNo<disabled><disabled>
Pf Prism Cv
CAPSULE;ORAL021446-001Dec 30, 2004RXNoRE41920<disabled> <disabled>
Pf Prism Cv
CAPSULE;ORAL021446-003Dec 30, 2004RXNo6,197,819<disabled>YY <disabled>
Pf Prism Cv
CAPSULE;ORAL021446-004Dec 30, 2004RXNo<disabled><disabled>
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International Patent Family for Ingredient: pregabalin

Country Document Number Publication Date
JapanH07508288Sep 14, 1995
Japan2000515149Nov 14, 2000
Portugal641330Mar 28, 2002
Canada2255652Jan 29, 1998
Finland945426Nov 18, 1994
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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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