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Last Updated: November 13, 2019

DrugPatentWatch Database Preview

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 suppliers are listed for this compound. Additional details are available on the pregabalin profile page.

Drug patent expirations by year for LYRICA
Drug Prices for LYRICA

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Drug Sales Revenue Trends for LYRICA

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Recent Clinical Trials for LYRICA

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SponsorPhase
University of UtahPhase 4
University of Missouri-ColumbiaPhase 3
Grünenthal GmbHPhase 3

See all LYRICA clinical trials

Recent Litigation for LYRICA

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District Court Litigation
Case NameDate
Pfizer Inc. v. Alphapharm Pty Ltd.2010-03-12
Pfizer Inc. v. Lupin Ltd.2009-04-29
Pfizer Inc. v. Wockhardt Limited2009-04-29

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   Start Trial   Start Trial   Start Trial
Pf Prism Cv LYRICA CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-003 Oct 11, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-005 Dec 30, 2004 AB RX Yes No   Start Trial   Start Trial   Start Trial
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-004 Dec 30, 2004 AB RX Yes No   Start Trial   Start Trial   Start Trial
Pf Prism Cv LYRICA CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-001 Oct 11, 2017 RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for LYRICA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-003 Dec 30, 2004   Start Trial   Start Trial
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-008 Dec 30, 2004   Start Trial   Start Trial
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-001 Dec 30, 2004   Start Trial   Start Trial
Pf Prism Cv LYRICA pregabalin SOLUTION;ORAL 022488-001 Jan 4, 2010   Start Trial   Start Trial
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-002 Dec 30, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for LYRICA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0934061 PA2004017 Lithuania   Start Trial PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RûGðTIS)
0934061 PA2004017,C0934061 Lithuania   Start Trial PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RUGSTIS); REGISTRATION NO/DATE: EU/1/04/279/001-025 20040725
0641330 27/2004 Austria   Start Trial PRODUCT NAME: PREGABALIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; REGISTRATION NO/DATE: EU/1/04/279/001 - EU/1/04/279/025 20040706
0641330 CR 2004 00036 Denmark   Start Trial PRODUCT NAME: PREGABALIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/04/279/001-025 20040706
0641330 91112 Luxembourg   Start Trial 91112, EXPIRES: 20180518
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.