Is there a generic for Lisdexamfetamine dimesylate?

Yes. The FDA Orange Book lists 22 approved generic (ANDA) applications for Lisdexamfetamine dimesylate, referencing the brand ARYNTA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Lisdexamfetamine dimesylate?

ARYNTA (NDA 219847, AZURITY) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Lisdexamfetamine dimesylate?

The Orange Book lists 3 patents against Lisdexamfetamine dimesylate products, with the earliest listed expiry in 2040. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Lisdexamfetamine dimesylate are approved?

Lisdexamfetamine dimesylate is approved in the following dosage forms: capsule, solution, tablet, chewable.

FDA Orange Book · active-ingredient family

Lisdexamfetamine dimesylate

Lisdexamfetamine dimesylate is approved as 3 brand and 22 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ARYNTA · NDA 219847

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule, solution, tablet, chewable

Product	Applicant	Application	TE	Approved
ARYNTARLD	AZURITY	NDA 219847	—	Jun 16, 2025
VYVANSERLD×6	TAKEDA PHARMS USA	NDA 208510	AB	Jan 28, 2017
VYVANSERLD×7	TAKEDA PHARMS USA	NDA 021977	AB	Oct 30, 2014

Generic (ANDA) products (22)

Product	Applicant	Application	TE	Approved
LISDEXAMFETAMINE DIMESYLATE×7	GRANULES	ANDA 218987	AB	Jan 29, 2025
LISDEXAMFETAMINE DIMESYLATE×7	SANDOZ	ANDA 202836	AB	Dec 26, 2024
LISDEXAMFETAMINE DIMESYLATE×6	SPECGX LLC	ANDA 218850	AB	Dec 17, 2024
LISDEXAMFETAMINE DIMESYLATE×6	GRANULES	ANDA 219258	AB	Dec 16, 2024
LISDEXAMFETAMINE DIMESYLATE×7	ELITE LABS INC	ANDA 218604	AB	Nov 15, 2024
LISDEXAMFETAMINE DIMESYLATE×6	MSN	ANDA 218306	AB	Feb 02, 2024
LISDEXAMFETAMINE DIMESYLATE×7	HIKMA	ANDA 202827	AB	Jan 17, 2024
LISDEXAMFETAMINE DIMESYLATE×7	ACTAVIS ELIZABETH	ANDA 202802	AB	Aug 25, 2023
LISDEXAMFETAMINE DIMESYLATE×7	ALKEM LABS LTD	ANDA 217194	AB	Aug 25, 2023
LISDEXAMFETAMINE DIMESYLATE×6	AMNEAL	ANDA 202830	AB	Aug 25, 2023
LISDEXAMFETAMINE DIMESYLATE×7	APOTEX	ANDA 216944	AB	Aug 25, 2023
LISDEXAMFETAMINE DIMESYLATE×7	ASCENT PHARMS INC	ANDA 217442	AB	Aug 25, 2023
LISDEXAMFETAMINE DIMESYLATE×7	LANNETT CO INC	ANDA 215802	AB	Aug 25, 2023
LISDEXAMFETAMINE DIMESYLATE×7	MYLAN	ANDA 202835	AB	Aug 25, 2023
LISDEXAMFETAMINE DIMESYLATE×7	NORWICH	ANDA 214547	AB	Aug 25, 2023
LISDEXAMFETAMINE DIMESYLATE×7	PRINSTON INC	ANDA 216266	AB	Aug 25, 2023
LISDEXAMFETAMINE DIMESYLATE×7	RHODES PHARMS	ANDA 215330	AB	Aug 25, 2023
LISDEXAMFETAMINE DIMESYLATE×7	SPECGX LLC	ANDA 211840	AB	Aug 25, 2023
LISDEXAMFETAMINE DIMESYLATE×7	SUN PHARM INDS INC	ANDA 214484	AB	Aug 25, 2023
LISDEXAMFETAMINE DIMESYLATE×6	ASCENT PHARMS INC	ANDA 217068	AB	Aug 25, 2023
LISDEXAMFETAMINE DIMESYLATE×6	SUN PHARM INDS INC	ANDA 214134	AB	Aug 25, 2023
LISDEXAMFETAMINE DIMESYLATE×6	TEVA PHARMS	ANDA 215415	AB	Aug 25, 2023

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 5 mo	Product

Lisdexamfetamine dimesylate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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