FDA Orange Book
Is there a generic for Arynta?
Arynta contains lisdexamfetamine. 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 Arynta (lisdexamfetamine). The Orange Book shows its last listed patent expires August 30, 2040.
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Arynta products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, oral | 10MG/ML | Marketed (Rx) | None | 0 | None |
NDA 219847, held by AZURITY PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Arynta patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12433859 | April 16, 2040 | Drug product | U-842 | 219847 |
| 12582620 | April 16, 2040 | Drug product | None | 219847 |
| 11576878 | August 30, 2040 | Drug product | None | 219847 |
Arynta NDC codes
Questions
Is there a generic for Arynta?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Arynta (lisdexamfetamine). The Orange Book shows its last listed patent expires August 30, 2040.
What is the generic name for Arynta?
The active ingredient in Arynta is lisdexamfetamine, per the FDA Orange Book.
When does the Arynta patent expire?
The last patent listed for Arynta in the Orange Book expires August 30, 2040. 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 Arynta and Lisdexamfetamine
- What is Arynta used for?FDA label uses
- Is Arynta a controlled substance?Schedule II
- What is Lisdexamfetamine used for?FDA label uses
- Is Lisdexamfetamine a controlled substance?Schedule II
- Generic for VyvanseFDA Orange Book
- Central Nervous System Stimulants listFDA drug class
- NDC 24338-019Arynta NDC record
- NDC 24338-103Arynta NDC record
- NDC 24338-109Arynta NDC record
- Schedule II drugs listDEA schedule