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Details for Generic Name: pregabalin

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Pregabalin is the generic ingredient in two branded drugs marketed by Pf Prism Cv, Lupin Ltd, Teva Pharms, and Watson Labs Inc, and is included in six 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-seven 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 list27
Suppliers: see list8
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

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

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: Neuralgia; Orofacial Pain

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

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;ORAL021446-002Dec 30, 2004RXNo6,197,819<disabled>YY<disabled>
Lupin Ltd
CAPSULE;ORAL091040-004Jul 3, 2012RXNo<disabled><disabled>
Pf Prism Cv
SOLUTION;ORAL022488-001Jan 4, 2010RXYes6,197,819<disabled>YY<disabled>
Pf Prism Cv
CAPSULE;ORAL021446-007Dec 30, 2004RXNoRE41920<disabled><disabled>
Lupin Ltd
CAPSULE;ORAL091040-001Jul 3, 2012RXNo<disabled><disabled>
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International Patent Family for Ingredient: pregabalin

Country Document Number Publication Date
Hong Kong1011022Mar 28, 2002
Australia3602497Feb 10, 1998
Hungary9702482Mar 02, 1998
Brazil9710536Aug 17, 1999
Japan2000515149Nov 14, 2000
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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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