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LYRICA CR Drug Profile

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When do Lyrica Cr patents expire, and when can generic versions of Lyrica Cr launch?

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

This drug has thirty-seven patent family members in thirty-three countries.

The generic ingredient in LYRICA CR 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.

US ANDA Litigation and Generic Entry Outlook for Lyrica Cr

A generic version of LYRICA CR was approved as pregabalin by ALEMBIC PHARMS LTD on July 19^th, 2019.

Summary for LYRICA CR

International Patents:	37
US Patents:	3
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Clinical Trials:	90
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

See drug prices for LYRICA CR

Paragraph IV (Patent) Challenges for LYRICA CR

Tradename	Dosage	Ingredient	NDA	Submissiondate
LYRICA CR	TABLET, EXTENDED RELEASE;ORAL	pregabalin	209501	2018-02-02
LYRICA CR	TABLET, EXTENDED RELEASE;ORAL	pregabalin	209501	2018-01-29

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	209501-002	Oct 11, 2017		RX	Yes	No					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	209501-003	Oct 11, 2017		RX	Yes	Yes					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

International Patents for LYRICA CR

Country	Patent Number	Estimated Expiration
Canada	2628200
Croatia	P970387
Poland	331325
Hungary	9904361
Peru	20070693
South Korea	100491282

Supplementary Protection Certificates for LYRICA CR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0641330	SPC016/2004	Ireland		SPC016/2004: 20050803, EXPIRES: 20180517
0641330	CA 2004 00036	Denmark
0641330	CR 2004 00036	Denmark		PRODUCT NAME: PREGABALIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/04/279/001-025 20040706
0934061	PA2004017,C0934061	Lithuania		PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RUGSTIS); REGISTRATION NO/DATE: EU/1/04/279/001-025 20040725
0641330	91112	Luxembourg		91112, EXPIRES: 20180518
0934061	PA2004017	Lithuania		PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RûGðTIS)