LISDEXAMFETAMINE DIMESYLATE - Generic Drug Details

What are the generic drug sources for lisdexamfetamine dimesylate and what is the scope of freedom to operate?

Lisdexamfetamine dimesylate is the generic ingredient in two branded drugs marketed by Actavis Elizabeth, Alkem Labs Ltd, Amneal, Apotex, Ascent Pharms Inc, Hikma, Lannett Co Inc, Mylan, Norwich, Prinston Inc, Rhodes Pharms, Specgx Llc, Sun Pharm Inds Inc, Takeda Pharms Usa, MSN, and Teva Pharms, and is included in nineteen NDAs. Additional information is available in the individual branded drug profile pages.

Fifteen suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for LISDEXAMFETAMINE DIMESYLATE

US Patents:	0
Tradenames:	2
Applicants:	16
NDAs:	19
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	44
Patent Applications:	199
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for LISDEXAMFETAMINE DIMESYLATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LISDEXAMFETAMINE DIMESYLATE
What excipients (inactive ingredients) are in LISDEXAMFETAMINE DIMESYLATE?	LISDEXAMFETAMINE DIMESYLATE excipients list
DailyMed Link:	LISDEXAMFETAMINE DIMESYLATE at DailyMed

See drug prices for LISDEXAMFETAMINE DIMESYLATE

Recent Clinical Trials for LISDEXAMFETAMINE DIMESYLATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Minnesota	Early Phase 1
Purdue Pharma, Canada	Phase 4
University of Birmingham	N/A

See all LISDEXAMFETAMINE DIMESYLATE clinical trials

Generic filers with tentative approvals for LISDEXAMFETAMINE DIMESYLATE

Applicant	Application No.	Strength	Dosage Form
		20MG	CAPSULE;ORAL
		70MG	CAPSULE;ORAL
		60MG	CAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for LISDEXAMFETAMINE DIMESYLATE

Drug Class	Central Nervous System Stimulant
Physiological Effect	Central Nervous System Stimulation

Medical Subject Heading (MeSH) Categories for LISDEXAMFETAMINE DIMESYLATE

Central Nervous System Stimulants

Dopamine Uptake Inhibitors

Paragraph IV (Patent) Challenges for LISDEXAMFETAMINE DIMESYLATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VYVANSE	Capsules	lisdexamfetamine dimesylate	10 mg	021977	1	2020-04-09
VYVANSE	Capsules	lisdexamfetamine dimesylate	20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg	021977	6	2011-02-23

US Patents and Regulatory Information for LISDEXAMFETAMINE DIMESYLATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ascent Pharms Inc	LISDEXAMFETAMINE DIMESYLATE	lisdexamfetamine dimesylate	CAPSULE;ORAL	217442-003	Aug 25, 2023	AB	RX	No	No
Hikma	LISDEXAMFETAMINE DIMESYLATE	lisdexamfetamine dimesylate	CAPSULE;ORAL	202827-007	Jan 17, 2024	AB	RX	No	No
Hikma	LISDEXAMFETAMINE DIMESYLATE	lisdexamfetamine dimesylate	CAPSULE;ORAL	202827-006	Aug 25, 2023	AB	RX	No	No
Teva Pharms	LISDEXAMFETAMINE DIMESYLATE	lisdexamfetamine dimesylate	TABLET, CHEWABLE;ORAL	215415-006	Aug 25, 2023		DISCN	No	No
Alkem Labs Ltd	LISDEXAMFETAMINE DIMESYLATE	lisdexamfetamine dimesylate	CAPSULE;ORAL	217194-004	Aug 25, 2023	AB	RX	No	No
Alkem Labs Ltd	LISDEXAMFETAMINE DIMESYLATE	lisdexamfetamine dimesylate	CAPSULE;ORAL	217194-005	Aug 25, 2023	AB	RX	No	No