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Last Updated: March 29, 2024

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, Alembic, Anchen Pharms, Aurobindo Pharma, Cipla, Jubilant Generics, Polygen Pharms, Torrent, Xiromed, and Abbvie, 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. Ten 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 Strength NDA ANDAs Submitted Submissiondate
ENABLEX Extended-release Tablets darifenacin hydrobromide 7.5 mg and 15 mg 021513 3 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
Polygen Pharms DARIFENACIN HYDROBROMIDE darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 211045-002 Jan 6, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbvie ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513-001 Dec 22, 2004 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Jubilant Generics DARIFENACIN HYDROBROMIDE darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 205550-001 Oct 12, 2016 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cipla DARIFENACIN HYDROBROMIDE darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 207664-001 Sep 1, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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
Abbvie ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513-001 Dec 22, 2004 ⤷  Try a Trial ⤷  Try a Trial
Abbvie ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513-001 Dec 22, 2004 ⤷  Try a Trial ⤷  Try a Trial
Abbvie ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513-002 Dec 22, 2004 ⤷  Try a Trial ⤷  Try a Trial
Abbvie ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513-002 Dec 22, 2004 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for DARIFENACIN HYDROBROMIDE

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
pharmaand GmbH Emselex darifenacin hydrobromide EMEA/H/C/000554
Symptomatic treatment of urge incontinence and/or increased urinary frequency and urgency as may occur in adult patients with overactive bladder syndrome.
Authorised no no no 2004-10-22
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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