FDA Orange Book
Generic for Xalatan
Xalatan contains latanoprost. 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 Xalatan is latanoprost. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AT.
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Xalatan products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution/drops, ophthalmic | 0.005% | Marketed (Rx) | AT | 7 | AT |
NDA 020597, held by UPJOHN US 2 LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic latanoprost
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| BAUSCH AND LOMB INC | 201006 | AT (A-rated, therapeutically equivalent) | March 22, 2011 | 0.005% |
| J MOLNER HOLDINGS INC | 200925 | AT (A-rated, therapeutically equivalent) | March 22, 2011 | 0.005% |
| SANDOZ INC | 091449 | AT (A-rated, therapeutically equivalent) | March 22, 2011 | 0.005% |
| SOMERSET THERAPEUTICS LLC | 201786 | AT (A-rated, therapeutically equivalent) | March 22, 2011 | 0.005% |
| FDC LTD | 202442 | AT (A-rated, therapeutically equivalent) | April 22, 2016 | 0.005% |
| GLAND PHARMA LTD | 218257 | AT (A-rated, therapeutically equivalent) | November 26, 2024 | 0.005% |
| MICRO LABS LTD | 219306 | AT (A-rated, therapeutically equivalent) | April 14, 2025 | 0.005% |
Xalatan NDC codes
Questions
Is there a generic for Xalatan?
Yes. The generic name for Xalatan is latanoprost. 7 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 Xalatan?
The active ingredient in Xalatan is latanoprost, 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.