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Generated: April 28, 2017

DrugPatentWatch Database Preview

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 two NDAs. It is available from thirteen suppliers. There are three patents protecting this drug and two Paragraph IV challenges. Additional details are available on the LYRICA profile page.

The generic ingredient in LYRICA is pregabalin. There are thirty-six drug master file entries for this compound. Thirteen suppliers are listed for this compound. There are ninety-one tentative approvals for this compound. Additional details are available on the pregabalin profile page.

Summary for NDA: 022488

Therapeutic Class:Anticonvulsants
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 022488

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLUTION;ORAL 022488 NDA Parke-Davis Div of Pfizer Inc 0071-1020 0071-1020-01 473 mL in 1 BOTTLE (0071-1020-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength20MG/ML
Approval Date:Jan 4, 2010TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 22, 2019
Regulatory Exclusivity Use:
Patent:6,197,819Patent Expiration:Dec 30, 2018Product Flag?YSubstance Flag?YDelist Request?
Patent:6,001,876Patent Expiration:Dec 30, 2018Product Flag?Substance Flag?Delist Request?Y

Expired Orange Book Patents for NDA: 022488

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv
SOLUTION;ORAL022488-001Jan 4, 20105,563,175► Subscribe
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