LISDEXAMFETAMINE DIMESYLATE - Generic Drug Details

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What are the generic sources for lisdexamfetamine dimesylate and what is the scope of patent protection?

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.

Summary for LISDEXAMFETAMINE DIMESYLATE

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

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

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

Anatomical Therapeutic Chemical (ATC) Classes for LISDEXAMFETAMINE DIMESYLATE

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

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Glossary

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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
Rhodes Pharms	LISDEXAMFETAMINE DIMESYLATE	lisdexamfetamine dimesylate	CAPSULE;ORAL	215330-002	Aug 25, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Takeda Pharms Usa	VYVANSE	lisdexamfetamine dimesylate	TABLET, CHEWABLE;ORAL	208510-005	Jan 28, 2017	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	LISDEXAMFETAMINE DIMESYLATE	lisdexamfetamine dimesylate	CAPSULE;ORAL	202827-001	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

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