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LYRICA Drug Profile

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

Lyrica is a drug marketed by Pf Prism Cv and is included in three NDAs. There are six patents protecting this drug and six Paragraph IV challenges.

This drug has sixty-eight patent family members in thirty-one countries.

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

US ANDA 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

International Patents:	68
US Patents:	3
Applicants:	1
NDAs:	3
Suppliers / Packagers:	11
Bulk Api Vendors:	86
Clinical Trials:	88
Patent Applications:	4,539
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for LYRICA
Drug Sales Revenues:	Drug sales revenues for LYRICA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LYRICA
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
University of Pennsylvania	Phase 2
University of Missouri-Columbia	Phase 2/Phase 3
Faculdade de Medicina do ABC	Phase 2

See all LYRICA clinical trials

Recent Litigation for LYRICA

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Pfizer Inc. v. Alphapharm Pty Ltd.	2010-03-12
Pfizer Inc. v. Lupin Ltd.	2009-04-29
Pfizer Inc. v. Wockhardt Limited	2009-04-29

See all LYRICA litigation

Synonyms for LYRICA

(3S)-3-(aminomethyl)-5-methyl hexanoic acid

(3S)-3-(aminomethyl)-5-methyl-hexanoic acid

(3S)-3-(aminomethyl)-5-methylhexanoic acid

(R-)-3-isobutyl GABA

(S)-(+)-3-Aminomethyl-5-Methylhexanoic Acid

(S)-(+)-4-amino-3-(2-methylpropyl)butanoic acid

(S)-3-(Aminomethyl)-5-methylhexanoic acid

(S)-3-(Aminomethyl)-5-methylhexanoicacid

(S)-3-Aminomethyl-5-methyl-hexanoic acid

(S)-3-aminomethyl-5-methylhexanoic acid

(S)-3-Isobutyl GABA

(S)-Pregabalin

121GE001

148553-50-8

3-isobutyl GABA

553P508

55JG375S6M

A808784

AB0074009

AB01563007_01

AB1008692

AC-1158

AC1NUP03

ACN-038395

AJ-08241

AKOS001476611

AKOS005145504

AM20080369

AN-1059

AYXYPKUFHZROOJ-ZETCQYMHSA-N

BC634849

BDBM50164279

CAS-148553-50-8

CCG-221247

CHEBI:64356

CHEMBL1059

CI 1008

CI-1008

CM14412

CP0100

CS-1247

CTK9A5767

D02716

DB00230

DEA No. 2782

DSSTox_CID_25950

DSSTox_GSID_45950

DSSTox_RID_81246

DTXSID1045950

EN300-92104

FT-0080911

GTPL5484

Hexanoic acid, 3-(aminomethyl)-5-ethyl-, (3S)-

Hexanoic acid, 3-(aminomethyl)-5-methyl-, (3S)-

Hexanoic acid, 3-(aminomethyl)-5-methyl-, (S)-

HMS3715J16

HSDB 7530

HY-17414

KB-01630

KS-00000AF5

KS-5378

KSC005O6P

LS-75191

Lyrica (TN)

MFCD00917044

NCGC00095186-01

NCGC00346738-01

Nervalin

PD 144723

PD-144723

Pregabalin

Pregabalin (JAN/USAN/INN)

Pregabalin [USAN:INN:BAN:JAN]

Pregabalin [USAN]

Pregabalin 1.0 mg/ml in Methanol

Pregabalin, >=97% (NMR)

Pregabalin, EuropePharmacopoeia (EP) Reference Standard

Pregablin

S-(+)-3-isobutylgaba

SC-11867

SCHEMBL8227

SR-01000942257

SR-01000942257-2

ST2408318

TL8001062

TOS-BB-0910

Tox21_111475

UNII-55JG375S6M

W-5218

Z2757554242

ZINC5152

Paragraph IV (Patent) Challenges for LYRICA

Tradename	Dosage	Ingredient	NDA	Submissiondate
LYRICA	SOLUTION;ORAL	pregabalin	022488	2010-05-19
LYRICA	CAPSULE;ORAL	pregabalin	021446	2008-12-30

US Patents and Regulatory Information for LYRICA

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	pregabalin	CAPSULE;ORAL	021446-008	Dec 30, 2004	AB	RX	Yes	Yes
Pf Prism Cv	LYRICA CR	pregabalin	TABLET, EXTENDED RELEASE;ORAL	209501-003	Oct 11, 2017		RX	Yes	Yes
Pf Prism Cv	LYRICA	pregabalin	CAPSULE;ORAL	021446-005	Dec 30, 2004	AB	RX	Yes	No
Pf Prism Cv	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
Pf Prism Cv	LYRICA	pregabalin	CAPSULE;ORAL	021446-005	Dec 30, 2004
Pf Prism Cv	LYRICA	pregabalin	CAPSULE;ORAL	021446-001	Dec 30, 2004
Pf Prism Cv	LYRICA	pregabalin	SOLUTION;ORAL	022488-001	Jan 4, 2010
Pf Prism Cv	LYRICA	pregabalin	CAPSULE;ORAL	021446-003	Dec 30, 2004

International Patents for LYRICA

Country	Patent Number	Estimated Expiration
Spain	2200184
Japan	2000515149
Norway	2008018
Hungary	222339

Supplementary Protection Certificates for LYRICA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	2004C/022	Belgium		PRODUCT NAME: PREGABALIN; REGISTRATION NO/DATE: EU/1/04/279/001 20040708