FDA Orange Book
Generic for Cogentin
Cogentin contains benztropine. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Cogentin is benztropine. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AP.
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Cogentin products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 1MG/ML | Discontinued | None | 4 | AP |
| tablet, oral | 0.5MG | Discontinued | None | 8 | AA |
| tablet, oral | 1MG | Discontinued | None | 8 | AA |
| tablet, oral | 2MG | Discontinued | None | 8 | AA |
NDA 012015, 009193, held by EPIC PHARMA LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic benztropine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PLIVA INC | 089058 | AA (A-rated, therapeutically equivalent) | August 10, 1988 | 0.5MG |
| PLIVA INC | 089059 | AA (A-rated, therapeutically equivalent) | August 10, 1988 | 1MG |
| PLIVA INC | 089060 | AA (A-rated, therapeutically equivalent) | August 10, 1988 | 2MG |
| EPIC PHARMA LLC | 072264 | AA (A-rated, therapeutically equivalent) | February 27, 1989 | 0.5MG |
| EPIC PHARMA LLC | 072265 | AA (A-rated, therapeutically equivalent) | February 27, 1989 | 1MG |
| EPIC PHARMA LLC | 072266 | AA (A-rated, therapeutically equivalent) | February 27, 1989 | 2MG |
| AIPING PHARMACEUTICAL INC | 040103 | AA (A-rated, therapeutically equivalent) | December 12, 1996 | 0.5MG, 1MG, 2MG |
| PH HEALTH LTD | 040715 | AA (A-rated, therapeutically equivalent) | August 27, 2007 | 0.5MG, 1MG, 2MG |
| FRESENIUS KABI USA LLC | 090233 | AP (A-rated, therapeutically equivalent) | July 28, 2009 | 1MG/ML |
| HIKMA FARMACEUTICA (PORTUGAL) SA | 090287 | AP (A-rated, therapeutically equivalent) | August 31, 2009 | 1MG/ML |
| LEADING PHARMA LLC | 090168 | AA (A-rated, therapeutically equivalent) | November 28, 2012 | 0.5MG, 1MG, 2MG |
| NAVINTA LLC | 091525 | AP (A-rated, therapeutically equivalent) | February 5, 2013 | 1MG/ML |
| NUVO PHARMACEUTICAL INC | 204713 | AA (A-rated, therapeutically equivalent) | April 14, 2015 | 0.5MG, 1MG, 2MG |
| HIKMA FARMACEUTICA PORTUGAL SA | 209442 | AP (A-rated, therapeutically equivalent) | October 14, 2021 | 1MG/ML |
| CHARTWELL RX SCIENCES LLC | 081265 | AA (A-rated, therapeutically equivalent) | November 29, 2023 | 0.5MG, 1MG, 2MG |
| QUAGEN PHARMACEUTICALS LLC | 212694 | AA (A-rated, therapeutically equivalent) | February 11, 2025 | 0.5MG, 1MG, 2MG |
Questions
Is there a generic for Cogentin?
Yes. The generic name for Cogentin is benztropine. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA, AP.
What is the generic name for Cogentin?
The active ingredient in Cogentin is benztropine, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.