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Last Updated: December 12, 2019

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Pregabalin - Generic Drug Details

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

Pregabalin is the generic ingredient in three branded drugs marketed by Pf Prism Cv, Alembic Pharms Ltd, Alkem Labs Ltd, Amneal Pharms Co, Dr Reddys, Hainan, Hetero Labs Ltd Iii, Invagen Pharms, Msn Labs Pvt Ltd, Mylan, Rising, Sciegen Pharms Inc, and Teva Pharms, and is included in eighteen NDAs. There are six 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 four patent family members in forty-five countries.

There are forty-one drug master file entries for pregabalin. Thirty-one suppliers are listed for this compound. There are thirteen tentative approvals for this compound.

Drug Prices for pregabalin

See drug prices for pregabalin

Drug Sales Revenue Trends for pregabalin

See drug sales revenues for pregabalin

Recent Clinical Trials for pregabalin

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of Missouri-ColumbiaPhase 2/Phase 3
University of UtahPhase 4
Ciusss de L'Est de l'Île de MontréalN/A

See all pregabalin clinical trials

Recent Litigation for pregabalin

Identify potential future generic entrants

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

See all pregabalin litigation

Generic filers with tentative approvals for PREGABALIN
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial200MGCAPSULE; ORAL
  Start Trial  Start Trial150MGCAPSULE; ORAL
  Start Trial  Start Trial100MGCAPSULE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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
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
Lyrica (TN)
MFCD00917044
NCGC00095186-01
NCGC00346738-01
Nervalin
PD 144723
PD-144723
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 PREGABALIN
Tradename Dosage Ingredient NDA Submissiondate
LYRICA CR TABLET, EXTENDED RELEASE;ORAL pregabalin 209501 2018-02-02
LYRICA CR TABLET, EXTENDED RELEASE;ORAL pregabalin 209501 2018-01-29
LYRICA SOLUTION;ORAL pregabalin 022488 2010-05-19
LYRICA CAPSULE;ORAL pregabalin 021446 2008-12-30

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
Mylan PREGABALIN pregabalin CAPSULE;ORAL 091228-008 Sep 20, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-006 Dec 30, 2004 AB RX Yes No   Start Trial   Start Trial   Start Trial
Amneal Pharms Co PREGABALIN pregabalin CAPSULE;ORAL 209743-008 Jul 19, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Sciegen Pharms Inc PREGABALIN pregabalin CAPSULE;ORAL 208677-001 Jul 19, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan PREGABALIN pregabalin CAPSULE;ORAL 091228-006 Sep 20, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-001 Dec 30, 2004 AB RX Yes No   Start Trial   Start Trial   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 pregabalin

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 021446-001 Dec 30, 2004   Start Trial   Start Trial
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-005 Dec 30, 2004   Start Trial   Start Trial
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-004 Dec 30, 2004   Start Trial   Start Trial
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-006 Dec 30, 2004   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 pregabalin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0641330 C00641330/01 Switzerland   Start Trial FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
0641330 300164 Netherlands   Start Trial 300164, 20130518, EXPIRES: 20180517
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 SPC/GB04/034 United Kingdom   Start 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/
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 91112 Luxembourg   Start Trial 91112, EXPIRES: 20180518
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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