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Last Updated: July 3, 2020

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Details for New Drug Application (NDA): 022488

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NDA 022488 describes LYRICA, which is a drug marketed by Pf Prism Cv and is included in three NDAs. It is available from eleven suppliers. There are three 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 022488
Applicant:Pf Prism Cv
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 022488
Suppliers and Packaging for NDA: 022488
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LYRICA pregabalin SOLUTION;ORAL 022488 NDA Parke-Davis Div of Pfizer Inc 0071-1020 0071-1020-01 473 mL in 1 BOTTLE (0071-1020-01)
LYRICA pregabalin SOLUTION;ORAL 022488 NDA AUTHORIZED GENERIC Greenstone LLC 59762-1576 59762-1576-1 1 BOTTLE in 1 CARTON (59762-1576-1) > 473 mL in 1 BOTTLE
Paragraph IV (Patent) Challenges for 022488
Tradename Dosage Ingredient NDA Submissiondate
LYRICA SOLUTION;ORAL pregabalin 022488 2010-05-19

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength20MG/ML
Approval Date:Jan 4, 2010TE:AARLD:Yes
Regulatory Exclusivity Expiration:May 23, 2022
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:May 3, 2021
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:Jun 22, 2020
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

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Serving leading biopharmaceutical companies globally:

Express Scripts
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