FDA Orange Book
Is there a generic for Altreno?
Altreno contains tretinoin. 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
No. The Orange Book lists no active FDA-approved generic (ANDA) for Altreno (tretinoin). The Orange Book shows its last listed patent expires August 22, 2038.
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Altreno products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| lotion, topical | 0.05% | Marketed (Rx) | None | 0 | None |
NDA 209353, held by DOW PHARMACEUTICAL SCIENCES. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Altreno patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10653656 | August 22, 2038 | Drug product | U-2368 | 209353 |
| 11324710 | August 22, 2038 | Method of use | U-2368 | 209353 |
Altreno NDC codes
Questions
Is there a generic for Altreno?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Altreno (tretinoin). The Orange Book shows its last listed patent expires August 22, 2038.
What is the generic name for Altreno?
The active ingredient in Altreno is tretinoin, per the FDA Orange Book.
When does the Altreno patent expire?
The last patent listed for Altreno in the Orange Book expires August 22, 2038. A listed patent expiry date is not a generic launch date.
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.
More on Altreno and Tretinoin
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- NDC 0187-0005Altreno NDC record