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Last Updated: December 13, 2019

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ENABLEX Drug Profile

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When do Enablex patents expire, and what generic alternatives are available?

Enablex is a drug marketed by Apil and is included in one NDA.

The generic ingredient in ENABLEX is darifenacin hydrobromide. There are nineteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the darifenacin hydrobromide profile page.

US ANDA Litigation and Generic Entry Outlook for Enablex

A generic version of ENABLEX was launched as darifenacin hydrobromide by ANCHEN PHARMS on December 13th, 2019.

Drug patent expirations by year for ENABLEX
Drug Prices for ENABLEX

See drug prices for ENABLEX

Recent Clinical Trials for ENABLEX

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

SponsorPhase
Astellas Scientific & Medical Affairs, Inc.N/A
Universidad de ValparaisoPhase 3
Recalcine (GynoPharm)Phase 3

See all ENABLEX clinical trials

Recent Litigation for ENABLEX

Identify potential future generic entrants

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

See all ENABLEX litigation

Pharmacology for ENABLEX
Synonyms for ENABLEX
(S)-1-(2-(2,3-Dihydro-5-benzofuranyl)ethyl)-alpha,alpha-diphenyl-3-pyrrolidineacetamide
(s)-1-[2-(2,3-dihydro-5-benzofuranyl) ethyl]-alpha,alpha-diphenyl-3-pyrrolidine acetamide
(S)-2-(1-(2-(2,3-dihydrobenzofuran-5-yl)ethyl)pyrrolidin-3-yl)-2,2-diphenylacetamide
(S)-2-{1-[2-(2,3-Dihydro-benzofuran-5-yl)-ethyl]-pyrrolidin-3-yl}-2,2-diphenyl-acetamide
(S)-2-{1-[2-(2,3-dihydrobenzofuran-5-yl)ethyl]-3-pyrrolidinyl}-2,2-diphenylacetamide
[3H]darifenacin
099D044
133099-04-4
2-((3S)-1-(2-(2,3-Dihydrobenzofuran-5-yl)ethyl)pyrrolidin-3-yl)-2,2-diphenylacetamide
2-[(3S)-1-[2-(2,3-dihydro-1-benzofuran-5-yl)ethyl]pyrrolidin-3-yl]-2,2-di(phenyl)acetamide
2-[(3S)-1-[2-(2,3-dihydro-1-benzofuran-5-yl)ethyl]pyrrolidin-3-yl]-2,2-diphenylacetamide
2-{(3S)-1-[2-(2,3-dihydro-1-benzofuran-5-yl)ethyl]pyrrolidin-3-yl}-2,2-diphenylacetamide
2-{1-[2-(2,3-Dihydro-benzofuran-5-yl)-ethyl]-pyrrolidin-3-yl}-2,2-diphenyl-acetamide (Darifenacin)
3-(S)-(-)-(1-carbamoyl-1,1-diphenylmethyl)-1-[2-(2,3-dihydrobenzofuran-5-y l)ethyl]pyrrolidine
3-(S)-(-)-(1-carbamoyl-1,1-diphenylmethyl)-1-[2-(2,3-dihydrobenzofuran-5-yl)ethyl]pyrrolidine
3-Pyrrolidineacetamide, 1-(2-(2,3-dihydro-5-benzofuranyl)ethyl)-alpha,alpha-diphenyl-, (3S)-
AB01566824_01
AC-302
AC1L9FKY
AJ-32303
AKOS015907962
APG9819VLM
API0002219
BC225565
BDBM50109647
CHEBI:391960
CHEMBL1346
CS-1168
D03654
Darifenacin
Darifenacin (USAN/INN)
Darifenacin [USAN:INN:BAN]
Darifenacina
darifenacine
Darifenacinum
DB00496
DTXSID2048290
Emselex
FT-0652801
GTPL319
GTPL321
HXGBXQDTNZMWGS-RUZDIDTESA-N
HY-A0033
LS-187359
MCULE-4616748439
MLS003876823
NCGC00168775-01
SB17425
SCHEMBL56574
SMR002533186
ST24039043
UK-88525
UNII-APG9819VLM
W-5196
ZINC1996117
Paragraph IV (Patent) Challenges for ENABLEX
Tradename Dosage Ingredient NDA Submissiondate
ENABLEX TABLET, EXTENDED RELEASE;ORAL darifenacin hydrobromide 021513 2008-12-22

US Patents and Regulatory Information for ENABLEX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apil ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513-001 Dec 22, 2004 AB RX Yes No   Start Trial   Start Trial   Start Trial
Apil ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513-002 Dec 22, 2004 AB RX Yes Yes   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 ENABLEX

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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Serving leading biopharmaceutical companies globally:

Moodys
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