Is Adzenys ER still available?

Adzenys ER (NDA 204325) is listed as Discontinued in the FDA Orange Book — it is no longer marketed. A discontinued status is not, by itself, a determination that the drug was withdrawn for safety or effectiveness.

Does Adzenys ER have a generic?

Yes. The Orange Book lists 1 approved generic (ANDA) application sharing Adzenys ER's active ingredient (Amphetamine). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

When do Adzenys ER's patents expire?

The FDA Orange Book lists 3 patents against Adzenys ER, with the last listed patent expiring Jun 28, 2032. A generic launching before a listed patent expires generally must file a Paragraph IV certification.

What is Adzenys ER's FDA application number?

Adzenys ER is approved under NDA 204325, held by Neos Theraps Inc.

Orange Book product · Brand (NDA)

Adzenys ER

Amphetamine

Brand (NDA)NDA 204325DiscontinuedRLD Neos Theraps Inc

Approved

Sep 15, 2017

Application

Brand (NDA)

TE code

Not listed

Listed patents

Adzenys ER (Amphetamine) is Neos Theraps Inc's brand-name drug, approved by the FDA under NDA 204325 in 2017. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. Its marketing status is listed as discontinued; a discontinued listing is not, by itself, a finding that the drug was withdrawn for safety or effectiveness. 1 approved generic share this drug's active ingredient. The FDA Orange Book lists 3 patents against it, the last expiring 2032.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Approval
FDA approval date of this drug product.
Sep 15, 2017
8 yr 11 mo ago
Today
Patent 8709491 expires
Listed drug product patent expiration.
Jun 28, 2032
in 6 yr 1 mo
Patent 9017731 expires
Listed drug product patent expiration.
Jun 28, 2032
in 6 yr 1 mo
Patent 9265737 expires
Listed drug product patent expiration.
Jun 28, 2032
in 6 yr 1 mo

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

FDA product record

Pharmaceutical detail

Active ingredient

AMPHETAMINE

Strength

EQ 1.25MG BASE/ML

Dosage form

SUSPENSION, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 204325

Product number

001

Marketing status

Discontinued

Reference listed drug (RLD)

Yes

Reference standard (RS)

Brand + generics

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

View full Amphetamine family

Orange Book patent file

Listed patents

Listed patents (3)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8709491	Jun 28, 2032	in 6 yr 1 mo	Product
9017731	Jun 28, 2032	in 6 yr 1 mo	Product
9265737	Jun 28, 2032	in 6 yr 1 mo	Product

Adzenys ER — frequently asked questions

Approval, therapeutic equivalence, patents, and exclusivity for this product, from the FDA Orange Book.

Built directly from the FDA Orange Book data file. This product page links back to the Amphetamine active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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