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LYRICA CR Drug Profile

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Which patents cover Lyrica Cr, and what generic alternatives are available?

Lyrica Cr is a drug marketed by Pf Prism Cv and is included in one NDA. There are five patents protecting this drug and four Paragraph IV challenges.

This drug has one hundred and four patent family members in forty-five countries.

The generic ingredient in LYRICA CR is pregabalin. There are forty-one drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the pregabalin profile page.

Summary for LYRICA CR

International Patents:	104
US Patents:	5
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Clinical Trials:	81
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for LYRICA CR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LYRICA CR
DailyMed Link:	LYRICA CR at DailyMed

Medical Subject Heading (MeSH) Categories for LYRICA CR

Analgesics

Anti-Anxiety Agents

Anticonvulsants

Calcium Channel Blockers

US Patents and Regulatory Information for LYRICA CR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pf Prism Cv	LYRICA CR	pregabalin	TABLET, EXTENDED RELEASE;ORAL	209501-001	Oct 11, 2017		RX	Yes	No					Y
Pf Prism Cv	LYRICA CR	pregabalin	TABLET, EXTENDED RELEASE;ORAL	209501-003	Oct 11, 2017		RX	Yes	Yes					Y
Pf Prism Cv	LYRICA CR	pregabalin	TABLET, EXTENDED RELEASE;ORAL	209501-001	Oct 11, 2017		RX	Yes	No
Pf Prism Cv	LYRICA CR	pregabalin	TABLET, EXTENDED RELEASE;ORAL	209501-001	Oct 11, 2017		RX	Yes	No					Y
Pf Prism Cv	LYRICA CR	pregabalin	TABLET, EXTENDED RELEASE;ORAL	209501-002	Oct 11, 2017		RX	Yes	No					Y
Pf Prism Cv	LYRICA CR	pregabalin	TABLET, EXTENDED RELEASE;ORAL	209501-003	Oct 11, 2017		RX	Yes	Yes

Paragraph IV (Patent) Challenges for LYRICA CR

Drugname	Dosage	Strength	RLD	Date
	Extended-release Tablets	330 mg
	Extended-release Tablets	82.5 mg and 165 mg
	Extended-release Tablets	82.5 mg and 165 mg
	Extended-release Tablets	330 mg

International Patents for LYRICA CR

Country	Document Number	Estimated Expiration
South Korea	100491282
Singapore	48288
Portugal	1945186
Australia	714980
Netherlands	2000281
China	1094757

Supplementary Protection Certificates for LYRICA CR

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
00164	Netherlands		PRODUCT NAME: PREGABALINE, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/04/279/001 20040706
C016/2004	Ireland		SPC016/2004: 20050803, EXPIRES: 20180517
2004 00036	Denmark
/2004	Austria		PRODUCT NAME: PREGABALIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; REGISTRATION NO/DATE: EU/1/04/279/001 - EU/1/04/279/025 20040706
2004017	Lithuania		PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RûGðTIS)
C/GB04/034	United Kingdom		PRODUCT NAME: PREGABALIN (S-(+)-4-AMINO-3(2-METHYLPROPYL)BUTANOIC ACID) OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACTIVE SALT.; REGISTERED: UK EU/1/04/279/001 20040706; UK EU/1/04/279/002 20040706; UK EU/1/04/279/003 20040706; UK EU/1/04/279/004 20040706; UK EU/1/04/279/005 20040706; UK EU/1/04/279/006 20040706; UK EU/1/04/279/025 20040706; UK EU/1/04/279/019 20040706; UK EU/1/04/279/020 20040706; UK EU/1/04/279/021 20040706; UK EU/1/04/279/022 20040706; UK EU/1/04/279/023 20040706; UK EU/1/04/279/024 20040706; UK EU/1/04/279/013 20040706; UK EU/1/04/279/014 20040706; UK EU/1/04/279/015 20040706; UK EU/1/04/279/016 20040706; UK EU/1/04/279/017 20040706; UK EU/1/04/279/018 20040706; UK EU/