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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 two NDAs. It is available from eleven 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-three drug master file entries for this compound. Eleven 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

Tradename:
LYRICA
Applicant:
Pf Prism Cv
Ingredient:
pregabalin
Patents:3
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
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;ORALStrength20MG/ML
Approval Date:Jan 4, 2010TE:RLD:Yes
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
Patented Use:MANAGEMENT OF FIBROMYALGIA
Patent:6,001,876Patent Expiration:Dec 30, 2018Product Flag?Substance Flag?Delist Request?Y
Patented Use:TREATMENT OF PAIN

Expired Orange Book Patents for NDA: 022488

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv
LYRICA
pregabalin
SOLUTION;ORAL022488-001Jan 4, 20105,563,175► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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