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Generated: August 26, 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 pregabalin patent protection?

Pregabalin is the generic ingredient in two branded drugs marketed by Pf Prism Cv and is included in three 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. Thirteen 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
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
Generic filers with tentative approvals for PREGABALIN
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up100MGCAPSULE; ORAL
➤ Sign Up➤ Sign Up75MGCAPSULE; ORAL
➤ Sign Up➤ Sign Up50MGCAPSULE; ORAL

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

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 021446-005 Dec 30, 2004 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-008 Dec 30, 2004 RX Yes Yes ➤ 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 CR pregabalin TABLET, EXTENDED RELEASE;ORAL 209501-003 Oct 11, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ 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
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-001 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 pregabalin

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pf Prism Cv LYRICA pregabalin SOLUTION;ORAL 022488-001 Jan 4, 2010 ➤ Sign Up ➤ Sign Up
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-008 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 021446-005 Dec 30, 2004 ➤ Sign Up ➤ Sign Up
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-007 Dec 30, 2004 ➤ Sign Up ➤ Sign Up
Pf Prism Cv LYRICA pregabalin CAPSULE;ORAL 021446-003 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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Supplementary Protection Certificates for pregabalin

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0641330 300164 Netherlands ➤ Sign Up 300164, 20130518, EXPIRES: 20180517
0641330 2004C/022 Belgium ➤ Sign Up PRODUCT NAME: PREGABALIN; REGISTRATION NO/DATE: EU/1/04/279/001 20040708
0934061 PA2004017,C0934061 Lithuania ➤ Sign Up PRODUCT NAME: PREGABALINUM ((S)-3-(AMINOMETIL)-5-METILHEKSANO RUGSTIS); REGISTRATION NO/DATE: EU/1/04/279/001-025 20040725
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
0641330 C00641330/01 Switzerland ➤ Sign Up FORMER REPRESENTANTIVE: E. BLUM AND CO. PATENTANWAELTE, CH
0641330 91112 Luxembourg ➤ Sign Up 91112, EXPIRES: 20180518
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Mallinckrodt
Cipla
Boehringer Ingelheim
Moodys
Medtronic
UBS

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.