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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Cerilliant
QuintilesIMS
Mallinckrodt
Moodys
Federal Trade Commission
Fish and Richardson
Johnson and Johnson
McKinsey

Generated: May 25, 2018

DrugPatentWatch Database Preview

Pregabalin - Generic Drug Details

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What are the generic sources for pregabalin and what is the scope of pregabalin patent protection?

Pregabalin
is the generic ingredient in two branded drugs marketed by Pf Prism Cv and Pfizer Inc, and is included in three NDAs. There are five patents protecting this compound and six Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Pregabalin has one hundred and three patent family members in forty-four countries.

There are thirty-nine drug master file entries for pregabalin. Eleven suppliers are listed for this compound. There are fifteen tentative approvals for this compound.
Medical Subject Heading (MeSH) Categories for pregabalin
Synonyms for pregabalin
(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
Lyrica (TN)
maxgalin
MFCD00917044
NCGC00095186-01
NCGC00346738-01
Nervalin
OR001726
OR223164
PD 144723
PD-144723
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
Tentative approvals for PREGABALIN
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial25MGCAPSULE; ORAL
➤ Try a Free Trial➤ Try a Free Trial300MGCAPSULE; ORAL
➤ Try a Free Trial➤ Try a Free Trial225MGCAPSULE; ORAL

US Patents and Regulatory Information for pregabalin

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 021446-003 Dec 30, 2004 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-001 Dec 30, 2004 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-006 Dec 30, 2004 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y 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
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 pregabalin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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 021446-004 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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Non-Orange Book US Patents for pregabalin

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
6,028,214 GABA and L-glutamic acid analogs for antiseizure treatment ➤ Try a Free Trial
5,608,090 GABA and L-glutamic acid analogs for antiseizure treatment ➤ Try a Free Trial
5,563,175 GABA and L-glutamic acid analogs for antiseizure treatment ➤ Try a Free Trial
6,525,096 GABA and L-glutamic acid analogs for antiseizure treatment ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for pregabalin

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C016/2004 Ireland ➤ Try a Free Trial SPC016/2004: 20050803, EXPIRES: 20180517
C/GB04/034 United Kingdom ➤ Try a Free Trial PRODUCT NAME: PREGABALIN (S-(+)-4-AMINO-3(2-METHYLPROPYL)BUTANOIC ACID) OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACTIVE SALT.; REGISTERED: UK EU/1/04/279/001 20040706; UK EU/1/04/279/002 20040706; UK EU/1/04/279/003 20040706; UK EU/1/04/279/004 20040706; UK EU/1/04/279/005 20040706; UK EU/1/04/279/006 20040706; UK EU/1/04/279/025 20040706; UK EU/1/04/279/019 20040706; UK EU/1/04/279/020 20040706; UK EU/1/04/279/021 20040706; UK EU/1/04/279/022 20040706; UK EU/1/04/279/023 20040706; UK EU/1/04/279/024 20040706; UK EU/1/04/279/013 20040706; UK EU/1/04/279/014 20040706; UK EU/1/04/279/015 20040706; UK EU/1/04/279/016 20040706; UK EU/1/04/279/017 20040706; UK EU/1/04/279/018 20040706; UK EU/
112 Luxembourg ➤ Try a Free Trial 91112, EXPIRES: 20180518
2004017 Lithuania ➤ Try a Free Trial PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RûGðTIS)
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Merck
Healthtrust
AstraZeneca
Julphar
Colorcon
Deloitte
Cerilliant
UBS

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