FDA Orange Book
Generic for Comtan
Comtan contains entacapone. 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 Comtan is entacapone. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Comtan products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 200MG | Marketed (Rx) | AB | 7 | AB |
NDA 020796, held by ORION PHARMA. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic entacapone
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| SUN PHARMACEUTICAL INDUSTRIES LTD | 090690 | AB (A-rated, therapeutically equivalent) | July 16, 2012 | 200MG |
| WOCKHARDT BIO AG | 078941 | AB (A-rated, therapeutically equivalent) | August 16, 2012 | 200MG |
| AUROBINDO PHARMA LTD | 203437 | AB (A-rated, therapeutically equivalent) | June 19, 2015 | 200MG |
| MACLEODS PHARMACEUTICALS LTD | 207210 | AB (A-rated, therapeutically equivalent) | June 5, 2017 | 200MG |
| AJANTA PHARMA LTD | 205792 | AB (A-rated, therapeutically equivalent) | August 31, 2017 | 200MG |
| SUNSHINE LAKE PHARMA CO LTD | 206669 | AB (A-rated, therapeutically equivalent) | October 3, 2018 | 200MG |
| ALEMBIC PHARMACEUTICALS LTD | 212601 | AB (A-rated, therapeutically equivalent) | January 4, 2022 | 200MG |
Comtan NDC codes
Questions
Is there a generic for Comtan?
Yes. The generic name for Comtan is entacapone. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Comtan?
The active ingredient in Comtan is entacapone, 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.