LYRICA Drug Patent Profile

When do Lyrica patents expire, and what generic alternatives are available?

Lyrica is a drug marketed by Upjohn and is included in three NDAs. There are three patents protecting this drug and two Paragraph IV challenges.

The generic ingredient in LYRICA 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

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

Summary for LYRICA

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	92
Clinical Trials:	153
Patent Applications:	5,413
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for LYRICA
Drug Sales Revenues:	Drug sales revenues for LYRICA
What excipients (inactive ingredients) are in LYRICA?	LYRICA excipients list
DailyMed Link:	LYRICA at DailyMed

See drug prices for LYRICA

See drug sales revenues for LYRICA

Recent Clinical Trials for LYRICA

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

Sponsor	Phase
UpJohn US 1 LLC	Phase 4
Mylan Inc.	Phase 4
CAMC Health System	Phase 4

See all LYRICA clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for LYRICA

N03AX	Other antiepileptics
N03A	ANTIEPILEPTICS
N03	ANTIEPILEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for LYRICA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LYRICA	Oral Solution	pregabalin	20 mg/mL	022488		2010-05-19
LYRICA	Capsules	pregabalin	25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg	021446		2008-12-30

US Patents and Regulatory Information for LYRICA

LYRICA is protected by zero US patents and two FDA Regulatory Exclusivities.

FDA Regulatory Exclusivity protecting LYRICA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-001	Dec 30, 2004	AB	RX	Yes	No
Upjohn	LYRICA	pregabalin	SOLUTION;ORAL	022488-001	Jan 4, 2010	AA	RX	Yes	Yes
Upjohn	LYRICA CR	pregabalin	TABLET, EXTENDED RELEASE;ORAL	209501-002	Oct 11, 2017	AB	RX	Yes	No					Y
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-004	Dec 30, 2004	AB	RX	Yes	No

Expired US Patents for LYRICA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-004	Dec 30, 2004
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-002	Dec 30, 2004
Upjohn	LYRICA	pregabalin	CAPSULE;ORAL	021446-001	Dec 30, 2004
Upjohn	LYRICA	pregabalin	SOLUTION;ORAL	022488-001	Jan 4, 2010

International Patents for LYRICA

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

Country	Patent Number	Title	Estimated Expiration
Japan	4297814
Finland	945426
Japan	3856816
Australia	9137091

Supplementary Protection Certificates for LYRICA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0641330	CA 2004 00036	Denmark
0934061	PA2004017	Lithuania		PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RûGðTIS)
0641330	SPC016/2004	Ireland		SPC016/2004: 20050803, EXPIRES: 20180517
0934061	PA2004017,C0934061	Lithuania		PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RUGSTIS); REGISTRATION NO/DATE: EU/1/04/279/001-025 20040725