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Last Updated: November 15, 2019

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Darifenacin hydrobromide - Generic Drug Details

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

Darifenacin hydrobromide is the generic ingredient in three branded drugs marketed by Macleods Pharms Ltd, Alembic Pharms Ltd, Anchen Pharms, Aurobindo Pharma Ltd, Cipla, Jubilant Generics, Torrent, and Apil, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are nineteen drug master file entries for darifenacin hydrobromide. Twelve suppliers are listed for this compound.

Recent Clinical Trials for darifenacin hydrobromide

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

SponsorPhase
Toronto Rehabilitation InstitutePhase 4
Ontario Neurotrauma FoundationPhase 4

See all darifenacin hydrobromide clinical trials

Recent Litigation for darifenacin hydrobromide

Identify potential future generic entrants

District Court Litigation
Case NameDate
Warner Chilcott Company LLC v. Torrent Pharmaceuticals Limited2013-12-18

See all darifenacin hydrobromide litigation

Pharmacology for darifenacin hydrobromide
Synonyms for darifenacin hydrobromide
(3S)-1-[2-(2,3-Dihydro-5-benzofuranyl)ethyl]-|A-|A-diphenyl-3-pyrrolidineacetamide Hydrobromide
(S)-2-(1-(2-(2,3-dihydrobenzofuran-5-yl)ethyl)pyrrolidin-3-yl)-2,2-diphenylacetamide hydrobromide
(S)-2-{1-(2-(2,3-Dihydrobenzofuran-5-yl)ethyl)-3-pyrrolidnyl}-2,2-diphenylacetamide hydrobromide
[1-[2-(2,3-DIHYDROBENZOFURAN-5-YL)ETHYL]-3-PYRROLIDNYL]-2,2-DIPHENYLACETAMIDE HYDROBROMIDE
133099-07-7
2-[(3S)-1-[2-(2,3-DIHYDRO-1-BENZOFURAN-5-YL)ETHYL]-3-PYRROLIDINYL]-2,2-DIPHENYLACETAMIDE HYDROBROMIDE
2-[(3S)-1-[2-(2,3-dihydro-1-benzofuran-5-yl)ethyl]pyrrolidin-3-yl]-2,2-diphenylacetamide hydrobromide
2-[(3S)-1-[2-(2,3-dihydro-1-benzofuran-5-yl)ethyl]pyrrolidin-3-yl]-2,2-diphenylacetamide;hydrobromide
2-[(3S)-1-[2-(2,3-dihydrobenzofuran-5-yl)ethyl]pyrrolidin-3-yl]-2,2-diphenyl-acetamide hydrobromide
2-{(3S)-1-[2-(2,3-dihydro-1-benzofuran-5-yl)ethyl]pyrrolidin-3-yl}-2,2-diphenylacetamide hydrobromide
3-Pyrrolidineacetamide, 1-(2-(2,3-dihydro-5-benzofuranyl)ethyl)-alpha,alpha-diphenyl-, monohydrobromide, (3S)-
3-Pyrrolidineacetamide, 1-(2-(2,3-dihydro-5-benzofuranyl)ethyl)-alpha,alpha-diphenyl-, monohydrobromide, (S)-
3-PYRROLIDINEACETAMIDE, 1-[2-(2,3-DIHYDRO-5-BENZOFURANYL)ETHYL]-ALPHA,ALPHA-DIPHENYL-, HYDROBROMIDE (1:1), (3S)-
AB0073012
AC-1894
AC1L9FKV
AKOS015969311
AN-6905
API0008085
AS-35087
BC003938
BC201082
CAS-133099-07-7
CCG-220969
CHEBI:31455
CHEMBL1200935
CR02EYQ8GV
CS-0380
D01699
Darifenacin (hydrobromide)
darifenacin HBr
Darifenacin hydrobromide (JAN/USAN)
Darifenacin hydrobromide [USAN]
Darifenacin hydrobromide, >=98% (HPLC)
Darifenacin hydrobromide, United States Pharmacopeia (USP) Reference Standard
Darilong
DSSTox_CID_26780
DSSTox_GSID_46780
DSSTox_RID_81899
DTXSID9046780
Emselex
Enablex (TN)
ENABLEX HYDROBROMIDE
HY-A0012
KS-00000KBH
LS-186532
MCULE-9754914075
MolPort-003-846-139
NCGC00168775-01
NCGC00263922-02
PubChem14816
Q-101006
s3144
SB17426
SW219426-1
Tox21_112636
Tox21_112636_1
UK 88525-04 hydrobromide
UK-88525
UK-88525-04
UK-88525-04 (HYDROBROMIDE)
UNII-CR02EYQ8GV
UQAVIASOPREUIT-VQIWEWKSSA-N
W-5366
Z1691545283
Paragraph IV (Patent) Challenges for DARIFENACIN HYDROBROMIDE
Tradename Dosage Ingredient NDA Submissiondate
ENABLEX TABLET, EXTENDED RELEASE;ORAL darifenacin hydrobromide 021513 2008-12-22

US Patents and Regulatory Information for darifenacin hydrobromide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alembic Pharms Ltd DARIFENACIN HYDROBROMIDE darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 207681-002 Dec 8, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Torrent DARIFENACIN HYDROBROMIDE darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 205209-001 Nov 17, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Cipla DARIFENACIN HYDROBROMIDE darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 207664-002 Sep 1, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd DARIFENACIN HYDROBROMIDE darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 206743-001 Sep 19, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd DARIFENACIN HYDROBROMIDE darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 206743-002 Sep 19, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Jubilant Generics DARIFENACIN HYDROBROMIDE darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 205550-001 Oct 12, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Macleods Pharms Ltd DARIFENACIN darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 207302-002 Jul 28, 2017 AB RX No 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 darifenacin hydrobromide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513-001 Dec 22, 2004   Start Trial   Start Trial
Apil ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513-002 Dec 22, 2004   Start Trial   Start Trial
Apil ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513-002 Dec 22, 2004   Start Trial   Start Trial
Apil ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513-001 Dec 22, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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.