Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 6, 2019

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 is included in three NDAs. It is available from ten suppliers. There are six 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 forty-one drug master file entries for this compound. Thirty-one 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
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 0071-1012-68 90 CAPSULE in 1 BOTTLE (0071-1012-68)
LYRICA pregabalin CAPSULE;ORAL 021446 NDA Parke-Davis Div of Pfizer Inc 0071-1013 0071-1013-41 100 BLISTER PACK in 1 CARTON (0071-1013-41) > 1 CAPSULE in 1 BLISTER PACK
Paragraph IV (Patent) Challenges for 021446
Tradename Dosage Ingredient NDA Submissiondate
LYRICA CAPSULE;ORAL pregabalin 021446 2008-12-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength25MG
Approval Date:Dec 30, 2004TE:ABRLD: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
Regulatory Exclusivity Expiration:May 23, 2022
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:May 3, 2021
Regulatory Exclusivity Use:NEW PATIENT POPULATION

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   Start Trial   Start Trial
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-005 Dec 30, 2004   Start Trial   Start Trial
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-004 Dec 30, 2004   Start Trial   Start Trial
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-002 Dec 30, 2004   Start Trial   Start Trial
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-006 Dec 30, 2004   Start Trial   Start Trial
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-007 Dec 30, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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