FDA Orange Book · active-ingredient family
Darifenacin hydrobromide
Darifenacin hydrobromide: 1 brand, 9 generics; first approved Dec 22, 2004; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 9 ANDA applications approved.
Brands (NDA)
1
Generics (ANDA)
9
Listed patents
0
Presentations
20
Brand (NDA) products
Originator applications
- ENABLEXRLDABBVIENDA 02151320042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 7.5MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 15MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued —
Generic (ANDA) products (9)
Abbreviated applications
- DARIFENACIN HYDROBROMIDEPURACAP LABS BLUANDA 21104520202 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 7.5MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 15MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB - DARIFENACIN HYDROBROMIDEXIROMEDANDA 20957120192 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 15MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 7.5MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — - DARIFENACIN HYDROBROMIDEALEMBICANDA 20768120172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 7.5MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 15MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB - MACLEODS PHARMS LTDANDA 20730220172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 7.5MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 15MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB - DARIFENACIN HYDROBROMIDETORRENTANDA 20520920162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 7.5MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 15MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB - DARIFENACIN HYDROBROMIDEJUBILANT GENERICSANDA 20555020162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 7.5MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 15MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — - DARIFENACIN HYDROBROMIDEAUROBINDO PHARMAANDA 20674320162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 7.5MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 15MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB - DARIFENACIN HYDROBROMIDECIPLAANDA 20766420162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 7.5MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB EQ 15MG BASE TABLET, EXTENDED RELEASE ORAL Rx AB - DARIFENACIN HYDROBROMIDEPH HEALTHANDA 09119020152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 7.5MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued — EQ 15MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued —
Listed patents
Orange Book patent file
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
FDA approval span
First approval
21 yr 11 mo ago
Most recent approval
6 yr 8 mo ago
Approvals span 2004–2020 across 10 FDA applications.
Brand (NDA) 110%
Generic (ANDA) 990%
Darifenacin hydrobromide: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
