FDA Orange Book · active-ingredient family
Benztropine mesylate
Benztropine mesylate is approved as 2 brand and 28 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:COGENTIN · NDA 012015
2
Brand (NDA)
28
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| COGENTINRLD | EPIC PHARMA LLC | NDA 012015 | — | Approved Prior to Jan 1, 1982 | |
| COGENTINRLD×3 | MERCK | NDA 009193 | — | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (28)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BENZTROPINE MESYLATE×3 | QUAGEN | ANDA 212694 | AA | Feb 11, 2025 | |
| BENZTROPINE MESYLATE×3 | CHARTWELL RX | ANDA 081265 | AA | Nov 29, 2023 | |
| BENZTROPINE MESYLATE | HIKMA | ANDA 209442 | AP | Oct 14, 2021 | |
| BENZTROPINE MESYLATE×3 | NUVO PHARM | ANDA 204713 | AA | Apr 14, 2015 | |
| BENZTROPINE MESYLATE | NAVINTA LLC | ANDA 091525 | AP | Feb 05, 2013 | |
| BENZTROPINE MESYLATE×3 | LEADING | ANDA 090168 | AA | Nov 28, 2012 | |
| BENZTROPINE MESYLATE | LUITPOLD | ANDA 091152 | — | Mar 29, 2010 | |
| BENZTROPINE MESYLATE×3 | INVAGEN PHARMS | ANDA 090294 | — | Mar 29, 2010 | |
| BENZTROPINE MESYLATE | HIKMA FARMACEUTICA | ANDA 090287 | AP | Aug 31, 2009 | |
| BENZTROPINE MESYLATE | FRESENIUS KABI USA | ANDA 090233 | AP | Jul 28, 2009 | |
| BENZTROPINE MESYLATE×3 | OXFORD PHARMS | ANDA 040706 | — | Feb 14, 2008 | |
| BENZTROPINE MESYLATE×3 | PH HEALTH | ANDA 040715 | AA | Aug 27, 2007 | |
| BENZTROPINE MESYLATE×3 | AIPING PHARM INC | ANDA 040103 | AA | Dec 12, 1996 | |
| BENZTROPINE MESYLATE | EPIC PHARMA LLC | ANDA 072264 | AA | Feb 27, 1989 | |
| BENZTROPINE MESYLATE | EPIC PHARMA LLC | ANDA 072265 | AA | Feb 27, 1989 | |
| BENZTROPINE MESYLATE | EPIC PHARMA LLC | ANDA 072266 | AA | Feb 27, 1989 | |
| BENZTROPINE MESYLATE | PLIVA | ANDA 089058 | AA | Aug 10, 1988 | |
| BENZTROPINE MESYLATE | PLIVA | ANDA 089059 | AA | Aug 10, 1988 | |
| BENZTROPINE MESYLATE | PLIVA | ANDA 089060 | AA | Aug 10, 1988 | |
| BENZTROPINE MESYLATE | USL PHARMA | ANDA 089211 | — | Jun 14, 1988 | |
| BENZTROPINE MESYLATE | USL PHARMA | ANDA 089212 | — | Jun 14, 1988 | |
| BENZTROPINE MESYLATE | USL PHARMA | ANDA 089213 | — | Jun 14, 1988 | |
| BENZTROPINE MESYLATE | LANNETT CO INC | ANDA 088877 | — | Apr 11, 1985 | |
| BENZTROPINE MESYLATE | LANNETT CO INC | ANDA 088894 | — | Apr 11, 1985 | |
| BENZTROPINE MESYLATE | LANNETT CO INC | ANDA 088895 | — | Apr 11, 1985 | |
| BENZTROPINE MESYLATE | QUANTUM PHARMICS | ANDA 088514 | — | Jan 31, 1984 | |
| BENZTROPINE MESYLATE | QUANTUM PHARMICS | ANDA 088510 | — | Jan 31, 1984 | |
| BENZTROPINE MESYLATE | QUANTUM PHARMICS | ANDA 088511 | — | Jan 31, 1984 |
Listed patents
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.
Benztropine mesylate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
