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Last Updated: August 13, 2020

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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 freedom to operate?

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

There are nineteen drug master file entries for darifenacin hydrobromide. Eleven 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

Pharmacology for DARIFENACIN HYDROBROMIDE
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
Apil ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513-002 Dec 22, 2004 AB RX Yes Yes   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
Anchen Pharms DARIFENACIN HYDROBROMIDE darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 091190-001 Mar 13, 2015 DISCN 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 021513-001 Dec 22, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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