FDA Orange Book · active-ingredient family
Cevimeline hydrochloride
Cevimeline hydrochloride: 1 brand, 9 generics; first approved Jan 11, 2000; 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
10
Brand (NDA) products
Originator applications
- COSETTENDA 0209892000
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG CAPSULE ORAL Rx AB
Generic (ANDA) products (9)
Abbreviated applications
- CEVIMELINE HYDROCHLORIDEZYDUS LIFESCIENCESANDA 2202672026
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG CAPSULE ORAL Rx AB - CEVIMELINE HYDROCHLORIDEMACLEODS PHARMS LTDANDA 2068082024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG CAPSULE ORAL Rx AB - CEVIMELINE HYDROCHLORIDEBIONPHARMAANDA 2182902023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG CAPSULE ORAL Rx AB - CEVIMELINE HYDROCHLORIDEAUROBINDO PHARMAANDA 2150562023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG CAPSULE ORAL Rx AB - CEVIMELINE HYDROCHLORIDERUBICON RESEARCHANDA 2166822023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG CAPSULE ORAL Rx AB - CEVIMELINE HYDROCHLORIDENOVEL LABS INCANDA 2047462016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG CAPSULE ORAL Rx AB - CEVIMELINE HYDROCHLORIDERISINGANDA 2037752014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG CAPSULE ORAL Rx AB - CEVIMELINE HYDROCHLORIDEHIKMAANDA 0915912013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG CAPSULE ORAL Rx AB - CEVIMELINE HYDROCHLORIDEAPOTEX INCANDA 0912602011
Approved strengths under this FDA application. Strength Dosage form Route Status TE 30MG CAPSULE 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
27 yr ago
Most recent approval
6 mo ago
Approvals span 2000–2026 across 10 FDA applications.
Brand (NDA) 110%
Generic (ANDA) 990%
Cevimeline hydrochloride: 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.
