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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

Analgesics
Anti-Anxiety Agents
Anticonvulsants
Calcium Channel Blockers

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:	RX	Dosage:	CAPSULE;ORAL			Strength	25MG
Approval Date:	Dec 30, 2004	TE:		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 Trial	Patent Expiration:	Dec 30, 2018	Product Flag?		Substance Flag?		Delist Request?	Y
Patented Use:	MANAGEMENT OF FIBROMYALGIA
Patent:	➤ Try a Free Trial	Patent Expiration:	Dec 30, 2018	Product Flag?		Substance Flag?		Delist Request?	Y
Patented Use:	TREATMENT OF PAIN

Expired US Patents for NDA 021446

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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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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.