FDA Orange Book
Generic for Artane
Artane contains trihexyphenidyl. 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 Artane is trihexyphenidyl. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA. Generics match 3 of the 5 Artane products the Orange Book lists.
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Artane products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, extended release, oral | 5MG | Discontinued | None | 0 | None |
| capsule, extended release, oral | 5MG | Discontinued | None | 0 | None |
| elixir, oral | 2MG/5ML | Discontinued | None | 2 | AA |
| tablet, oral | 2MG | Discontinued | None | 3 | AA |
| tablet, oral | 5MG | Discontinued | None | 3 | AA |
NDA 006773, 012947, held by LEDERLE LABORATORIES DIV AMERICAN CYANAMID CO. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic trihexyphenidyl
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| PHARMACEUTICAL ASSOCIATES INC | 040177 | AA (A-rated, therapeutically equivalent) | April 17, 1997 | 2MG/5ML |
| NOVITIUM PHARMA LLC | 040254 | AA (A-rated, therapeutically equivalent) | December 24, 1998 | 2MG, 5MG |
| CHARTWELL RX SCIENCES LLC | 040251 | AA (A-rated, therapeutically equivalent) | September 27, 1999 | 2MG/5ML |
| NATCO PHARMA LTD | 091630 | AA (A-rated, therapeutically equivalent) | November 17, 2010 | 2MG, 5MG |
| WATSON LABORATORIES INC | 084363 | AA (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 2MG |
| WATSON LABORATORIES INC | 084364 | AA (A-rated, therapeutically equivalent) | Approved Prior to Jan 1, 1982 | 5MG |
Questions
Is there a generic for Artane?
Yes. The generic name for Artane is trihexyphenidyl. 5 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AA. Generics match 3 of the 5 Artane products the Orange Book lists.
What is the generic name for Artane?
The active ingredient in Artane is trihexyphenidyl, 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.