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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 Pfizer 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-four 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:	95
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for LYRICA CR
What excipients (inactive ingredients) are in LYRICA CR?	LYRICA CR excipients list
DailyMed Link:	LYRICA CR at DailyMed

See drug prices for LYRICA CR

Recent Clinical Trials for LYRICA CR

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
CAMC Health System	Phase 4
Vanderbilt University Medical Center	Phase 4
Zagazig University	N/A

See all LYRICA CR clinical trials

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
Pfizer	LYRICA CR	pregabalin	TABLET, EXTENDED RELEASE;ORAL	209501-001	Oct 11, 2017		RX	Yes	No					Y
Pfizer	LYRICA CR	pregabalin	TABLET, EXTENDED RELEASE;ORAL	209501-002	Oct 11, 2017		RX	Yes	No					Y
Pfizer	LYRICA CR	pregabalin	TABLET, EXTENDED RELEASE;ORAL	209501-001	Oct 11, 2017		RX	Yes	No
Pfizer	LYRICA CR	pregabalin	TABLET, EXTENDED RELEASE;ORAL	209501-003	Oct 11, 2017		RX	Yes	Yes					Y
Pfizer	LYRICA CR	pregabalin	TABLET, EXTENDED RELEASE;ORAL	209501-002	Oct 11, 2017		RX	Yes	No					Y
Pfizer	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
Portugal	641330
Mexico	9302970
Israel	190827
Serbia	20080181
Hungary	T71522
Cuba	22850

Supplementary Protection Certificates for LYRICA CR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0641330	C300164	Netherlands		PRODUCT NAME: PREGABALINE, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/04/279/001 20040706
0641330	SPC016/2004	Ireland		SPC016/2004: 20050803, EXPIRES: 20180517
0641330	C00641330/01	Switzerland		FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
0641330	SPC/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/
0641330	300164	Netherlands		300164, 20130518, EXPIRES: 20180517
0641330	CA 2004 00036	Denmark