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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Healthtrust
AstraZeneca
Citi
Fuji
Chubb
Julphar
Colorcon
Queensland Health

Generated: June 21, 2018

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 Pfizer Inc and is included in three NDAs. There are five 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 thirty-nine drug master file entries for this compound. Twelve 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 pregabalin CAPSULE;ORAL 021446-007 Dec 30, 2004 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pf Prism Cv LYRICA pregabalin SOLUTION;ORAL 022488-001 Jan 4, 2010 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Pfizer Inc LYRICA CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-001 Oct 11, 2017 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-008 Dec 30, 2004 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
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 021446-002 Dec 30, 2004 ➤ Sign Up ➤ Sign Up
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-001 Dec 30, 2004 ➤ Sign Up ➤ Sign Up
Pf Prism Cv LYRICA pregabalin SOLUTION;ORAL 022488-001 Jan 4, 2010 ➤ Sign Up ➤ Sign Up
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-004 Dec 30, 2004 ➤ Sign Up ➤ Sign Up
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 Submissiondate
➤ Subscribe Extended-release Tablets 330 mg ➤ Subscribe 2018-01-29
➤ Subscribe Extended-release Tablets 330 mg ➤ Subscribe 2018-01-29
➤ Subscribe Extended-release Tablets 82.5 mg and 165 mg ➤ Subscribe 2018-02-02
➤ Subscribe Extended-release Tablets 82.5 mg and 165 mg ➤ Subscribe 2018-02-02
➤ Subscribe Oral Solution 20 mg/mL ➤ Subscribe 2010-05-19
➤ Subscribe Capsules 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg ➤ Subscribe 2008-12-30

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
5,684,189 GABA and L-glutamic acid analogs for antiseizure treatment ➤ Sign Up
6,414,024 GABA and L-glutamic acid analogs for antiseizure treatment ➤ Sign Up
5,847,151 Gaba and L-glutamic acid analogs for antiseizure treatment ➤ Sign Up
6,028,214 GABA and L-glutamic acid analogs for antiseizure treatment ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for LYRICA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0641330/01 Switzerland ➤ Sign Up FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
00164 Netherlands ➤ Sign Up PRODUCT NAME: PREGABALINE, DESGEWENST IN DE; REGISTRATION NO/DATE: EU/1/04/279/001 20040706
2004017,C0934061 Lithuania ➤ Sign Up PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RUGSTIS); REGISTRATION NO/DATE: EU/1/04/279/001-025 20040725
2004 00036 Denmark ➤ Sign Up PRODUCT NAME: PREGABALIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/04/279/001-025 20040706
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Medtronic
Merck
Baxter
Federal Trade Commission
Daiichi Sankyo
US Army
Chubb
Farmers Insurance

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