FDA Orange Book · active-ingredient family
Benztropine mesylate
Benztropine mesylate: 2 brands, 28 generics; first approved Jan 31, 1984; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 28 ANDA applications approved.
Brands (NDA)
2
Generics (ANDA)
28
Listed patents
0
Presentations
48
Brand (NDA) products
Originator applications
- COGENTINRLDEPIC PHARMA LLCNDA 012015—
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — - COGENTINRLDMERCKNDA 009193—3 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — 0.5MG TABLET ORAL Discontinued —
Generic (ANDA) products (28)
Abbreviated applications
- BENZTROPINE MESYLATEQUAGENANDA 21269420253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Rx AA 1MG TABLET ORAL Rx AA 2MG TABLET ORAL Rx AA - BENZTROPINE MESYLATECHARTWELL RXANDA 08126520233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Rx AA 1MG TABLET ORAL Rx AA 0.5MG TABLET ORAL Rx AA - BENZTROPINE MESYLATEHIKMAANDA 2094422021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - BENZTROPINE MESYLATERSNUVO PHARMANDA 20471320153 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Rx AA 1MG TABLET ORAL Rx AA 2MG TABLET ORAL Rx AA - BENZTROPINE MESYLATENAVINTA LLCANDA 0915252013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - BENZTROPINE MESYLATELEADINGANDA 09016820123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Rx AA 1MG TABLET ORAL Rx AA 2MG TABLET ORAL Rx AA - BENZTROPINE MESYLATELUITPOLDANDA 0911522010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Discontinued — - BENZTROPINE MESYLATEINVAGEN PHARMSANDA 09029420103 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — 2MG TABLET ORAL Discontinued — - BENZTROPINE MESYLATERSHIKMA FARMACEUTICAANDA 0902872009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - BENZTROPINE MESYLATEFRESENIUS KABI USAANDA 0902332009
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/ML INJECTABLE INJECTION Rx AP - BENZTROPINE MESYLATEOXFORD PHARMSANDA 04070620083 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Discontinued — 0.5MG TABLET ORAL Discontinued — 1MG TABLET ORAL Discontinued — - BENZTROPINE MESYLATEPH HEALTHANDA 04071520073 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Rx AA 1MG TABLET ORAL Rx AA 2MG TABLET ORAL Rx AA - BENZTROPINE MESYLATEAIPING PHARM INCANDA 04010319963 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Rx AA 1MG TABLET ORAL Rx AA 2MG TABLET ORAL Rx AA - BENZTROPINE MESYLATEEPIC PHARMA LLCANDA 0722641989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Rx AA - BENZTROPINE MESYLATEEPIC PHARMA LLCANDA 0722651989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AA - BENZTROPINE MESYLATEEPIC PHARMA LLCANDA 0722661989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Rx AA - BENZTROPINE MESYLATEPLIVAANDA 0890581988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Rx AA - BENZTROPINE MESYLATEPLIVAANDA 0890591988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Rx AA - BENZTROPINE MESYLATEPLIVAANDA 0890601988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Rx AA - BENZTROPINE MESYLATEUSL PHARMAANDA 0892111988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Discontinued — - BENZTROPINE MESYLATEUSL PHARMAANDA 0892121988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - BENZTROPINE MESYLATEUSL PHARMAANDA 0892131988
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Discontinued — - BENZTROPINE MESYLATELANNETT CO INCANDA 0888771985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Discontinued — - BENZTROPINE MESYLATELANNETT CO INCANDA 0888941985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - BENZTROPINE MESYLATELANNETT CO INCANDA 0888951985
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET ORAL Discontinued — - BENZTROPINE MESYLATEQUANTUM PHARMICSANDA 0885141984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.5MG TABLET ORAL Discontinued — - BENZTROPINE MESYLATEQUANTUM PHARMICSANDA 0885101984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG TABLET ORAL Discontinued — - BENZTROPINE MESYLATEQUANTUM PHARMICSANDA 0885111984
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2MG TABLET 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
43 yr 2 mo ago
Most recent approval
1 yr 6 mo ago
Approvals span 1984–2025 across 30 FDA applications.
Brand (NDA) 27%
Generic (ANDA) 2893%
Benztropine mesylate: 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.
