FDA Orange Book
Generic for Adzenys XR-ODT
Adzenys XR-ODT contains amphetamine. 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 Adzenys XR-ODT is amphetamine. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Adzenys XR-ODT products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, orally disintegrating, extended release, oral | EQ 12.5MG BASE | Marketed (Rx) | AB | 1 | AB |
| tablet, orally disintegrating, extended release, oral | EQ 15.7MG BASE | Marketed (Rx) | AB | 1 | AB |
| tablet, orally disintegrating, extended release, oral | EQ 18.8MG BASE | Marketed (Rx) | AB | 1 | AB |
| tablet, orally disintegrating, extended release, oral | EQ 3.1MG BASE | Marketed (Rx) | AB | 1 | AB |
| tablet, orally disintegrating, extended release, oral | EQ 6.3MG BASE | Marketed (Rx) | AB | 1 | AB |
| tablet, orally disintegrating, extended release, oral | EQ 9.4MG BASE | Marketed (Rx) | AB | 1 | AB |
NDA 204326, held by NEOS THERAPEUTICS. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic amphetamine
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS LABORATORIES FL INC | 209253 | AB (A-rated, therapeutically equivalent) | June 22, 2023 | EQ 12.5MG BASE, EQ 15.7MG BASE, EQ 18.8MG BASE, EQ 3.1MG BASE, EQ 6.3MG BASE, EQ 9.4MG BASE |
Adzenys XR-ODT patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8840924 | April 9, 2026 | Drug product | None | 204326 |
| 8709491 | June 28, 2032 | Drug product | None | 204326 |
| 9839619 | June 28, 2032 | Drug product | None | 204326 |
| 9017731 | June 28, 2032 | Drug product | None | 204326 |
| 9265737 | June 28, 2032 | Drug product | None | 204326 |
Adzenys XR-ODT NDC codes
Questions
Is there a generic for Adzenys XR-ODT?
Yes. The generic name for Adzenys XR-ODT is amphetamine. 1 company holds an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Adzenys XR-ODT?
The active ingredient in Adzenys XR-ODT is amphetamine, per the FDA Orange Book.
When does the Adzenys XR-ODT patent expire?
The last patent listed for Adzenys XR-ODT in the Orange Book expires June 28, 2032. 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 Adzenys XR-ODT and Amphetamine
- What is Adzenys XR-ODT used for?FDA label uses
- Is Adzenys XR-ODT a controlled substance?Schedule II
- What is Amphetamine used for?FDA label uses
- Is Amphetamine a controlled substance?Schedule II
- Central Nervous System Stimulants listFDA drug class
- NDC 70165-005Adzenys XR-ODT NDC record
- NDC 70165-010Adzenys XR-ODT NDC record
- NDC 70165-015Adzenys XR-ODT NDC record
- Schedule II drugs listDEA schedule