Dextroamphetamine sulfate - Generic Drug Details

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

Dextroamphetamine sulfate is the generic ingredient in six branded drugs marketed by Impax Labs Inc, Able, Actavis Elizabeth, Dr Reddys Labs Sa, Nesher Pharms, Norvium Bioscience, Specgx Llc, Strides Pharma, Teva, Glaxosmithkline, Prasco, Tris Pharma Inc, Ani Pharms, Aurolife Pharma Llc, Avanthi Inc, Azurity, Barr, Epic Pharma Llc, Halsey, Lannett, Mast Mm, Novel Labs Inc, Nuvo Pharm, Purepac Pharm, Sandoz, Vitarine, Winder Labs Llc, Shire, and Ferndale Labs, and is included in forty NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for dextroamphetamine sulfate. Sixteen suppliers are listed for this compound.

Sponsor	Phase
Vallon Pharmaceuticals, Inc.	Phase 1
Medical University of Vienna	N/A
Centre hospitalier de l'Université de Montréal (CHUM)	Phase 2

Sponsor

Phase

Vallon Pharmaceuticals, Inc.

Phase 1

Medical University of Vienna

N/A

Centre hospitalier de l'Université de Montréal (CHUM)

Phase 2

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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	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	076353-001	May 6, 2003	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lannett	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate	TABLET;ORAL	083903-003	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Tris Pharma Inc	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate	TABLET;ORAL	206095-001	Aug 18, 2022		DISCN	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:	6
Applicants:	29
NDAs:	40
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	22
Clinical Trials:	8
Patent Applications:	6,814
Drug Prices:	Drug price trends for dextroamphetamine sulfate
What excipients (inactive ingredients) are in dextroamphetamine sulfate?	dextroamphetamine sulfate excipients list
DailyMed Link:	dextroamphetamine sulfate at DailyMed

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