FDA Orange Book
Is there a generic for Natesto?
Natesto contains testosterone. 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 Natesto (testosterone). The Orange Book shows its last listed patent expires March 17, 2034.
Run it in Rivvi
Map Natesto and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Natesto products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| gel, metered, nasal | 5.5MG/0.122GM ACTUATION | Marketed (Rx) | None | 0 | None |
NDA 205488, held by ACERUS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Natesto patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11744838 | March 17, 2034 | Method of use | U-4366 | 205488 |
| 11744838 | March 17, 2034 | Method of use | U-4367 | 205488 |
| 11090312 | March 17, 2034 | Method of use | U-1616 | 205488 |
Natesto NDC codes
Questions
Is there a generic for Natesto?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Natesto (testosterone). The Orange Book shows its last listed patent expires March 17, 2034.
What is the generic name for Natesto?
The active ingredient in Natesto is testosterone, per the FDA Orange Book.
When does the Natesto patent expire?
The last patent listed for Natesto in the Orange Book expires March 17, 2034. 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 Natesto and Testosterone
- What is Natesto used for?FDA label uses
- Is Natesto a controlled substance?Schedule III
- What is Testosterone used for?FDA label uses
- Is Testosterone a controlled substance?Schedule III
- Generic for AndrogelFDA Orange Book
- Generic for FortestaFDA Orange Book
- Generic for VogelxoFDA Orange Book
- Generic for TestimFDA Orange Book
- Generic for AxironFDA Orange Book
- Androgens listFDA drug class
- NDC 42667-5511Natesto NDC record
- Schedule III drugs listDEA schedule