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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

Tradenames:1
Patents:3
Applicants:1
NDAs:2
Drug Master File Entries: see list28
Suppliers: see list8
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details

Tentative approvals for PREGABALIN

Applicant Application No. Form Dosage
<disabled><disabled>CAPSULE; ORAL50MG
<disabled><disabled>CAPSULE; ORAL300MG
<disabled><disabled>CAPSULE; ORAL75MG

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 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;ORAL021446-004Dec 30, 2004RXNo6,001,876<disabled>Y<disabled>
Pf Prism Cv
LYRICA
pregabalin
SOLUTION;ORAL022488-001Jan 4, 2010RXYesRE41920<disabled><disabled>
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-002Dec 30, 2004RXNo<disabled><disabled>
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-001Dec 30, 2004RXNoRE41920<disabled><disabled>
Pf Prism Cv
LYRICA
pregabalin
CAPSULE;ORAL021446-005Dec 30, 2004RXNo<disabled><disabled>
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International Patent Family for Ingredient: pregabalin

Country Document Number Publication Date
New Zealand253459Mar 24, 1997
Mexico9302970May 31, 1994
World Intellectual Property Organization (WIPO)9803167Jan 29, 1998
Russian Federation2140901Nov 10, 1999
Mexico9102241Jan 31, 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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