FDA Orange Book
Generic for Trusopt
Trusopt contains dorzolamide. 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 Trusopt is dorzolamide. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.
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Trusopt products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution/drops, ophthalmic | EQ 2% BASE | Discontinued | None | 10 | AT |
NDA 020408, held by MERCK SHARP AND DOHME LLC A SUB OF MERCK AND CO INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic dorzolamide
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| RUBICON RESEARCH LTD | 078395 | AT (A-rated, therapeutically equivalent) | October 28, 2008 | EQ 2% BASE |
| SANDOZ INC | 078748 | AT (A-rated, therapeutically equivalent) | November 6, 2008 | EQ 2% BASE |
| SANDOZ INC | 078981 | AT (A-rated, therapeutically equivalent) | April 13, 2009 | EQ 2% BASE |
| BAUSCH AND LOMB INC | 090143 | AT (A-rated, therapeutically equivalent) | June 25, 2009 | EQ 2% BASE |
| REGCON HOLDINGS LLC | 202053 | AT (A-rated, therapeutically equivalent) | September 11, 2014 | EQ 2% BASE |
| FDC LTD | 205294 | AT (A-rated, therapeutically equivalent) | January 24, 2019 | EQ 2% BASE |
| ALEMBIC PHARMACEUTICALS LTD | 212639 | AT (A-rated, therapeutically equivalent) | August 9, 2019 | EQ 2% BASE |
| MICRO LABS LTD | 204778 | AT (A-rated, therapeutically equivalent) | November 8, 2019 | EQ 2% BASE |
| GLAND PHARMA LTD | 215660 | AT (A-rated, therapeutically equivalent) | January 27, 2022 | EQ 2% BASE |
| SOMERSET THERAPEUTICS LLC | 215004 | AT (A-rated, therapeutically equivalent) | February 11, 2025 | EQ 2% BASE |
Questions
Is there a generic for Trusopt?
Yes. The generic name for Trusopt is dorzolamide. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.
What is the generic name for Trusopt?
The active ingredient in Trusopt is dorzolamide, 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.