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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Daiichi Sankyo
McKesson
Merck
Dow
Harvard Business School
Moodys
Teva
Express Scripts

Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021446

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NDA 021446 describes LYRICA, which is a drug marketed by Pf Prism Cv and Pfizer Inc and is included in three NDAs. It is available from eleven suppliers. There are five patents protecting this drug and six Paragraph IV challenges. Additional details are available on the LYRICA profile page.

The generic ingredient in LYRICA is pregabalin. There are thirty-nine drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the pregabalin profile page.
Summary for 021446
Tradename:LYRICA
Applicant:Pf Prism Cv
Ingredient:pregabalin
Patents:3
Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 021446
Suppliers and Packaging for NDA: 021446
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LYRICA pregabalin CAPSULE;ORAL 021446 NDA Parke-Davis Div of Pfizer Inc 0071-1012 N 0071-1012-68
LYRICA pregabalin CAPSULE;ORAL 021446 NDA Parke-Davis Div of Pfizer Inc 0071-1013 N 0071-1013-41

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Dec 30, 2004TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 22, 2019
Regulatory Exclusivity Use:INFORMATION ADDED TO THE LABELING REGARDING A 15-WEEK, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED FLEXIBLE-DOSE SAFETY AND EFFICACY STUDY OF PREGABALIN IN ADOLESCENTS (12 THROUGH 17 YEARS OLD) WITH FIBROMYALGIA
Patent:➤ Try a Free TrialPatent Expiration:Dec 30, 2018Product Flag?Substance Flag?Delist Request?Y
Patented Use:MANAGEMENT OF FIBROMYALGIA
Patent:➤ Try a Free TrialPatent Expiration:Dec 30, 2018Product Flag?Substance Flag?Delist Request?Y
Patented Use:TREATMENT OF PAIN

Expired US Patents for NDA 021446

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-001 Dec 30, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-004 Dec 30, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-002 Dec 30, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-003 Dec 30, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Farmers Insurance
Moodys
Dow
QuintilesIMS
Federal Trade Commission
Daiichi Sankyo
Citi
Covington

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