FDA Orange Book
Generic for Cosopt
Cosopt contains dorzolamide and timolol. 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 Cosopt is dorzolamide and timolol. 13 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT1, AT2.
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Cosopt products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution/drops, ophthalmic | EQ 2% BASE;EQ 0.5% BASE | Marketed (Rx) | AT1 | 16 | AT1, AT2 |
NDA 020869, held by THEA PHARMA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic dorzolamide and timolol
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| RUBICON RESEARCH LTD | 078201 | AT1 (A-rated, therapeutically equivalent) | October 28, 2008 | EQ 2% BASE;EQ 0.5% BASE |
| SANDOZ INC | 078749 | AT1 (A-rated, therapeutically equivalent) | November 6, 2008 | EQ 2% BASE;EQ 0.5% BASE |
| BAUSCH AND LOMB INC | 090037 | AT1 (A-rated, therapeutically equivalent) | July 14, 2009 | EQ 2% BASE;EQ 0.5% BASE |
| SANDOZ INC | 090604 | AT1 (A-rated, therapeutically equivalent) | November 18, 2009 | EQ 2% BASE;EQ 0.5% BASE |
| REGCON HOLDINGS LLC | 202054 | AT1 (A-rated, therapeutically equivalent) | September 3, 2014 | EQ 2% BASE;EQ 0.5% BASE |
| EPIC PHARMA LLC | 203058 | AT1 (A-rated, therapeutically equivalent) | September 22, 2014 | EQ 2% BASE;EQ 0.5% BASE |
| EUGIA PHARMA SPECIALITIES LTD | 207630 | AT2 (A-rated, therapeutically equivalent) | July 24, 2018 | EQ 2% BASE;EQ 0.5% BASE |
| FDC LTD | 205295 | AT1 (A-rated, therapeutically equivalent) | June 13, 2019 | EQ 2% BASE;EQ 0.5% BASE |
| SOMERSET THERAPEUTICS LLC | 207523 | AT1 (A-rated, therapeutically equivalent) | June 25, 2019 | EQ 2% BASE;EQ 0.5% BASE |
| MICRO LABS LTD | 204777 | AT1 (A-rated, therapeutically equivalent) | May 28, 2020 | EQ 2% BASE;EQ 0.5% BASE |
| ALEMBIC PHARMACEUTICALS LTD | 213099 | AT1 (A-rated, therapeutically equivalent) | May 4, 2021 | EQ 2% BASE;EQ 0.5% BASE |
| EUGIA PHARMA SPECIALITIES LTD | 207629 | AT1 (A-rated, therapeutically equivalent) | May 14, 2021 | EQ 2% BASE;EQ 0.5% BASE |
| MICRO LABS LTD | 215936 | AT2 (A-rated, therapeutically equivalent) | January 25, 2022 | EQ 2% BASE;EQ 0.5% BASE |
| GLAND PHARMA LTD | 215520 | AT1 (A-rated, therapeutically equivalent) | September 19, 2022 | EQ 2% BASE;EQ 0.5% BASE |
| INGENUS PHARMACEUTICALS LLC | 217260 | AT2 (A-rated, therapeutically equivalent) | May 1, 2023 | EQ 2% BASE;EQ 0.5% BASE |
| ALEMBIC THERAPEUTICS LLC | 216308 | AT2 (A-rated, therapeutically equivalent) | February 18, 2025 | EQ 2% BASE;EQ 0.5% BASE |
Cosopt NDC codes
Questions
Is there a generic for Cosopt?
Yes. The generic name for Cosopt is dorzolamide and timolol. 13 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT1, AT2.
What is the generic name for Cosopt?
The active ingredient in Cosopt is dorzolamide and timolol, 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.