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LYRICA Drug Profile

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

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.

The generic ingredient in LYRICA is pregabalin. There are thirty-nine drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the pregabalin profile page.

Summary for LYRICA

US Patents:	3
Applicants:	1
NDAs:	3
Suppliers / Packagers:	10
Bulk Api Vendors:	78
Clinical Trials:	73
Patent Applications:	3,666
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for LYRICA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LYRICA
DailyMed Link:	LYRICA at DailyMed

Medical Subject Heading (MeSH) Categories for LYRICA

Analgesics

Anti-Anxiety Agents

Anticonvulsants

Calcium Channel Blockers

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

AJ-08241

AK-73128

AKOS001476611

AKOS005145504

AM20080369

AN-1059

AYXYPKUFHZROOJ-ZETCQYMHSA-N

BC634849

BDBM50164279

C8H17NO2

CAS-148553-50-8

CCG-221247

CHEBI:64356

CHEMBL1059

CI 1008

CI-1008

CM14412

CP0100

CS-1247

CTK9A5767

D00WUF

D02716

DB00230

DEA No. 2782

DSSTox_CID_25950

DSSTox_GSID_45950

DSSTox_RID_81246

DTXSID1045950

EN300-92104

FT-0080911

gabanext

GTPL5484

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

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

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

HSDB 7530

HY-17414

KB-01630

KS-00000AF5

KS-5378

KSC005O6P

LS-75191

Lyrica (TN)

maxgalin

MFCD00917044

NCGC00095186-01

NCGC00346738-01

Nervalin

OR001726

OR223164

PD 144723

PD-144723

Pregabalin

Pregabalin (controlled-release, oral)

Pregabalin (controlled-release, oral), Pfizer

Pregabalin (JAN/USAN/INN)

Pregabalin [USAN:INN:BAN:JAN]

Pregabalin [USAN]

Pregabalin 1.0 mg/ml in Methanol

Pregabalin CR

pregabalin HCl

pregabalin hydrochloride

Pregabalin, >=97% (NMR)

Pregabalin, EuropePharmacopoeia (EP) Reference Standard

Pregablin

S-(+)-3-isobutylgaba

SBB062901

SC-11867

SCHEMBL8227

SR-01000942257

SR-01000942257-2

ST2408318

TL8001062

TOS-BB-0910

Tox21_111475

UNII-55JG375S6M

W-5218

Z2757554242

ZINC5152

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 CR	pregabalin	TABLET, EXTENDED RELEASE;ORAL	209501-002	Oct 11, 2017		RX	Yes	No
Pf Prism Cv	LYRICA	pregabalin	CAPSULE;ORAL	021446-007	Dec 30, 2004		RX	Yes	No
Pf Prism Cv	LYRICA	pregabalin	SOLUTION;ORAL	022488-001	Jan 4, 2010		RX	Yes	Yes					Y

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Expired US Patents for LYRICA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pf Prism Cv	LYRICA	pregabalin	CAPSULE;ORAL	021446-007	Dec 30, 2004
Pf Prism Cv	LYRICA	pregabalin	CAPSULE;ORAL	021446-006	Dec 30, 2004
Pf Prism Cv	LYRICA	pregabalin	CAPSULE;ORAL	021446-008	Dec 30, 2004

Paragraph IV (Patent) Challenges for LYRICA

Drugname	Dosage	Strength	RLD	Date
	Extended-release Tablets	330 mg
	Extended-release Tablets	330 mg
	Extended-release Tablets	82.5 mg and 165 mg
	Extended-release Tablets	82.5 mg and 165 mg
	Oral Solution	20 mg/mL
	Capsules	25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg

Non-Orange Book US Patents for LYRICA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
6,262,120	GABA and L-glutamic acid analogs for antiseizure treatment
6,291,526	GABA and L-glutamic acid analogs for antiseizure treatment
6,525,096	GABA and L-glutamic acid analogs for antiseizure treatment

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International Patents for LYRICA

Country	Document Number	Estimated Expiration
Poland	189872
Spain	2200184
Australia	3602497

Supplementary Protection Certificates for LYRICA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2004017	Lithuania		PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RûGðTIS)
0164	Netherlands		300164, 20130518, EXPIRES: 20180517
2004017,C0934061	Lithuania		PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RUGSTIS); REGISTRATION NO/DATE: EU/1/04/279/001-025 20040725