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Generated: December 19, 2018

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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.

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

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

Drug patent expirations by year for LYRICA
Medical Subject Heading (MeSH) Categories for LYRICA
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 ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-007 Dec 30, 2004 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pf Prism Cv LYRICA pregabalin SOLUTION;ORAL 022488-001 Jan 4, 2010 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-008 Dec 30, 2004 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pf Prism Cv LYRICA CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-001 Oct 11, 2017 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Pf Prism Cv LYRICA CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-001 Oct 11, 2017 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-005 Dec 30, 2004 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 ➤ Try a Free Trial ➤ Try a Free Trial
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-005 Dec 30, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-001 Dec 30, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-006 Dec 30, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-004 Dec 30, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-002 Dec 30, 2004 ➤ Try a Free Trial ➤ Try a Free Trial
Pf Prism Cv LYRICA pregabalin SOLUTION;ORAL 022488-001 Jan 4, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for LYRICA
Drugname Dosage Strength RLD Date
➤ Subscribe Extended-release Tablets 82.5 mg and 165 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Extended-release Tablets 82.5 mg and 165 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Extended-release Tablets 330 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Extended-release Tablets 330 mg ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Oral Solution 20 mg/mL ➤ Subscribe ➤ Try a Free Trial
➤ Subscribe Capsules 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg ➤ Subscribe ➤ Try a Free Trial

International Patents for LYRICA

Supplementary Protection Certificates for LYRICA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2004 00036 Denmark ➤ Try a Free Trial
2004017,C0934061 Lithuania ➤ Try a Free Trial PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RUGSTIS); REGISTRATION NO/DATE: EU/1/04/279/001-025 20040725
112 Luxembourg ➤ Try a Free Trial 91112, EXPIRES: 20180518
2004017 Lithuania ➤ Try a Free Trial PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RûGðTIS)
04C/022 Belgium ➤ Try a Free Trial PRODUCT NAME: PREGABALIN; REGISTRATION NO/DATE: EU/1/04/279/001 20040708
2004 00036 Denmark ➤ Try a Free Trial PRODUCT NAME: PREGABALIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/04/279/001-025 20040706
/2004 Austria ➤ Try a Free 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Deloitte
Express Scripts
Daiichi Sankyo
Boehringer Ingelheim
QuintilesIMS
Cipla
Cantor Fitzgerald
Queensland Health

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