LISDEXAMFETAMINE DIMESYLATE - Generic Drug Details

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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, Sandoz, Specgx Llc, Sun Pharm Inds Inc, Takeda Pharms Usa, MSN, and Teva Pharms, and is included in twenty NDAs. Additional information is available in the individual branded drug profile pages.

Seventeen suppliers are listed for this compound.

Sponsor

Phase

University of Minnesota

Early Phase 1

Purdue Pharma, Canada

Phase 4

University of Birmingham

N/A

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

Tradename

Dosage

Ingredient

Strength

NDA

ANDAs Submitted

Submissiondate

Capsules

10 mg

2020-04-09

Capsules

20 mg, 30 mg, 40 mg, 50 mg, 60 mg and 70 mg

2011-02-23

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Specgx Llc	LISDEXAMFETAMINE DIMESYLATE	lisdexamfetamine dimesylate	CAPSULE;ORAL	211840-002	Aug 25, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Specgx Llc	LISDEXAMFETAMINE DIMESYLATE	lisdexamfetamine dimesylate	CAPSULE;ORAL	211840-006	Aug 25, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sandoz	LISDEXAMFETAMINE DIMESYLATE	lisdexamfetamine dimesylate	CAPSULE;ORAL	202836-001	Jul 26, 2024		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Ascent Pharms Inc	LISDEXAMFETAMINE DIMESYLATE	lisdexamfetamine dimesylate	TABLET, CHEWABLE;ORAL	217068-002	Aug 25, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Alkem Labs Ltd	LISDEXAMFETAMINE DIMESYLATE	lisdexamfetamine dimesylate	CAPSULE;ORAL	217194-004	Aug 25, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

US Patents:	0
Tradenames:	2
Applicants:	17
NDAs:	20
Finished Product Suppliers / Packagers:	17
Raw Ingredient (Bulk) Api Vendors:	23
Clinical Trials:	44
Patent Applications:	193
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

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