FDA Orange Book
Is there a generic for Azstarys?
Azstarys contains dexmethylphenidate and serdexmethylphenidate chloride. 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 Azstarys (dexmethylphenidate and serdexmethylphenidate chloride). The Orange Book shows its last listed patent expires December 9, 2037 and its last listed exclusivity ends May 7, 2026.
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Azstarys products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 10.4MG BASE;EQ 52.3MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 5.2MG BASE;EQ 26.1MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 7.8MG BASE;EQ 39.2MG BASE | Marketed (Rx) | None | 0 | None |
NDA 212994, held by COMMAVE SUB LLC A WHOLLY OWNED SUB OF COLLEGIUM PHARMACEUTICAL INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Azstarys patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9079928 | May 7, 2035 | Drug product | None | 212994 |
| 10858341 | December 9, 2037 | Method of use | U-3094 | 212994 |
| 10954213 | December 9, 2037 | Method of use | U-3094 | 212994 |
| 10584112 | December 9, 2037 | Drug substance, Drug product | None | 212994 |
| 10584113 | December 9, 2037 | Drug product | None | 212994 |
| 10759778 | December 9, 2037 | Drug product | None | 212994 |
Azstarys exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | May 7, 2026 | 212994 |
Azstarys NDC codes
Questions
Is there a generic for Azstarys?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Azstarys (dexmethylphenidate and serdexmethylphenidate chloride). The Orange Book shows its last listed patent expires December 9, 2037 and its last listed exclusivity ends May 7, 2026.
What is the generic name for Azstarys?
The active ingredient in Azstarys is dexmethylphenidate and serdexmethylphenidate chloride, per the FDA Orange Book.
When does the Azstarys patent expire?
The last patent listed for Azstarys in the Orange Book expires December 9, 2037. 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 Azstarys and Dexmethylphenidate and Serdexmethylphenidate Chloride
- What is Azstarys used for?FDA label uses
- Is Azstarys a controlled substance?Schedule II
- Is Dexmethylphenidate and Serdexmethylphenidate Chloride a controlled substance?Schedule II
- Central Nervous System Stimulants listFDA drug class
- NDC 65038-286Azstarys NDC record
- NDC 65038-429Azstarys NDC record
- NDC 65038-561Azstarys NDC record
- Schedule II drugs listDEA schedule