LYRICA CR Drug Patent Profile

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

Lyrica Cr is a drug marketed by Upjohn and is included in one NDA. There are three patents protecting this drug and two 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-seven suppliers are listed for this compound. Additional details are available on the pregabalin profile page.

DrugPatentWatch^® 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
Finished Product Suppliers / Packagers:	2
Clinical Trials:	153
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
Mylan Inc.	Phase 4
UpJohn US 1 LLC	Phase 4
Vanderbilt University Medical Center	Phase 4

See all LYRICA CR clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for LYRICA CR

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for LYRICA CR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LYRICA CR	Extended-release Tablets	pregabalin	82.5 mg and 165 mg	209501	1	2018-02-02
LYRICA CR	Extended-release Tablets	pregabalin	330 mg	209501	1	2018-01-29

US Patents and Regulatory Information for LYRICA CR

LYRICA CR is protected by three US patents.

Patents protecting LYRICA CR

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

International Patents for LYRICA CR

When does loss-of-exclusivity occur for LYRICA CR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

China

Costa Rica

Cyprus

Denmark

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Guatemala

Hong Kong

Israel

Japan

Montenegro

Morocco

Netherlands

New Zealand

Norway

Peru

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering LYRICA CR around the world.

Country	Patent Number	Title	Estimated Expiration
Israel	190827	PHARMACEUTICAL COMPOSITION COMPRISING PREGABALIN AND THE USE OF THE PHARMACEUTICAL COMPOSITION IN THE MANUFACTURE OF A MEDICAMENT
Hungary	9702482
Norway	20081816
Denmark	0641330

Supplementary Protection Certificates for LYRICA CR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	CR 2004 00036	Denmark		PRODUCT NAME: PREGABALIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/04/279/001-025 20040706
0641330	C300164	Netherlands		PRODUCT NAME: PREGABALINE, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/04/279/001 20040706
0934061	PA2004017,C0934061	Lithuania		PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RUGSTIS); REGISTRATION NO/DATE: EU/1/04/279/001-025 20040725