Is Arynta still available?

Yes. Arynta (NDA 219847) is listed with marketing status Prescription in the FDA Orange Book.

Does Arynta have a generic?

Yes. The Orange Book lists 22 approved generic (ANDA) applications sharing Arynta's active ingredient (Lisdexamfetamine Dimesylate). A generic with an "A"-rated therapeutic-equivalence code is considered substitutable for the brand.

When do Arynta's patents expire?

The FDA Orange Book lists 3 patents against Arynta, with the last listed patent expiring Aug 30, 2040. A generic launching before a listed patent expires generally must file a Paragraph IV certification.

What is Arynta's FDA application number?

Arynta is approved under NDA 219847, held by Azurity.

Orange Book product · Brand (NDA)

Arynta

Lisdexamfetamine Dimesylate

Brand (NDA)NDA 219847RLD Azurity

Approved

Jun 16, 2025

Application

Brand (NDA)

TE code

Not listed

Listed patents

Arynta (Lisdexamfetamine Dimesylate) is Azurity's brand-name drug, approved by the FDA under NDA 219847 in 2025. It is a reference-listed drug (RLD) — the approved product that generic ANDA applicants must show their version is equivalent to. 22 approved generics share this drug's active ingredient. The FDA Orange Book lists 3 patents against it, the last expiring 2040.

Sourced from the FDA Orange Book

Approval, patents, exclusivity

Key dates

Approval
FDA approval date of this drug product.
Jun 16, 2025
1 yr 1 mo ago
Today
Patent 12433859 expires
Listed drug product patent expiration.
Apr 16, 2040
in 14 yr
Patent 12582620 expires
Listed drug product patent expiration.
Apr 16, 2040
in 14 yr
Patent 11576878 expires
Listed drug product patent expiration.
Aug 30, 2040
in 14 yr 4 mo

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

FDA product record

Pharmaceutical detail

Active ingredient

LISDEXAMFETAMINE DIMESYLATE

Strength

10MG/ML

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 219847

Product number

001

Marketing status

Prescription

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

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 Lisdexamfetamine Dimesylate 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
12433859	Apr 16, 2040	in 14 yr	ProductU-842
12582620	Apr 16, 2040	in 14 yr	Product
11576878	Aug 30, 2040	in 14 yr 4 mo	Product

Arynta — 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 Lisdexamfetamine Dimesylate active-ingredient family, which is the canonical reference for generics, patents, and exclusivity across all strengths.

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