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Cantor Fitzgerald
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Julphar
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Generated: April 26, 2019

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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. 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
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

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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-006 Dec 30, 2004 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-005 Dec 30, 2004 RX Yes No ➤ 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 021446-003 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 CAPSULE;ORAL 021446-002 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 Date
➤ Subscribe Extended-release Tablets 330 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Extended-release Tablets 330 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Extended-release Tablets 82.5 mg and 165 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Extended-release Tablets 82.5 mg and 165 mg ➤ Subscribe ➤ Sign Up
➤ Subscribe Oral Solution 20 mg/mL ➤ Subscribe ➤ Sign Up
➤ Subscribe Capsules 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for LYRICA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0641330 SPC016/2004 Ireland ➤ Sign Up SPC016/2004: 20050803, EXPIRES: 20180517
0641330 CA 2004 00036 Denmark ➤ Sign Up
0641330 27/2004 Austria ➤ Sign Up PRODUCT NAME: PREGABALIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; REGISTRATION NO/DATE: EU/1/04/279/001 - EU/1/04/279/025 20040706
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Baxter
Daiichi Sankyo
Argus Health
McKesson
US Army

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