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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; 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
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;ORAL021446-008Dec 30, 2004RXYes6,001,876<disabled>Y <disabled>
Pf Prism Cv
CAPSULE;ORAL021446-004Dec 30, 2004RXNo6,001,876<disabled>Y <disabled>
Pf Prism Cv
CAPSULE;ORAL021446-003Dec 30, 2004RXNo6,197,819<disabled>YY <disabled>
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International Patent Family for Ingredient: pregabalin

Country Document Number Publication Date
Japan3693258Sep 07, 2005
CroatiaP970387Oct 31, 1998
Czech Republic9402849Mar 15, 1995
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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.

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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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