Dextroamphetamine - Generic Drug Details

What are the generic drug sources for dextroamphetamine and what is the scope of patent protection?

Dextroamphetamine is the generic ingredient in six branded drugs marketed by Noven Pharms Inc, Impax Labs Inc, Able, Actavis Elizabeth, Dr Reddys Labs Sa, Mylan, Nesher Pharms, Specgx Llc, Strides Pharma, Teva, Glaxosmithkline, Prasco, Tris Pharma Inc, Ani Pharms, Arbor Pharms Llc, Aurolife Pharma Llc, Avanthi Inc, 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-one NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dextroamphetamine has thirty-three patent family members in twelve countries.

There are eighteen drug master file entries for dextroamphetamine. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for dextroamphetamine

International Patents:	33
US Patents:	6
Tradenames:	6
Applicants:	30
NDAs:	41
Drug Master File Entries:	18
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	17
Clinical Trials:	32
Patent Applications:	6,647
Drug Prices:	Drug price trends for dextroamphetamine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for dextroamphetamine
What excipients (inactive ingredients) are in dextroamphetamine?	dextroamphetamine excipients list
DailyMed Link:	dextroamphetamine at DailyMed

See drug prices for dextroamphetamine

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for dextroamphetamine

Constraining patent/regulatory exclusivity:

NEW PRODUCT

Dosage:

SYSTEM;TRANSDERMAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for dextroamphetamine

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

Sponsor	Phase
Eva Szigethy	Phase 4
The Beckwith Institute	Phase 4
Vallon Pharmaceuticals, Inc.	Phase 1

See all dextroamphetamine clinical trials

Generic filers with tentative approvals for DEXTROAMPHETAMINE

Applicant	Application No.	Strength	Dosage Form
		30MG	CAPSULE, EXTENDED RELEASE;ORAL
		25MG	CAPSULE, EXTENDED RELEASE;ORAL
		20MG	CAPSULE, EXTENDED RELEASE;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 dextroamphetamine

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

US Patents and Regulatory Information for dextroamphetamine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Nesher Pharms	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	209111-002	Jun 27, 2017		DISCN	No	No
Noven Pharms Inc	XELSTRYM	dextroamphetamine	SYSTEM;TRANSDERMAL	215401-004	Mar 22, 2022		RX	Yes	Yes			Y
Noven Pharms Inc	XELSTRYM	dextroamphetamine	SYSTEM;TRANSDERMAL	215401-003	Mar 22, 2022		RX	Yes	No			Y
Novel Labs Inc	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate	TABLET;ORAL	204330-001	Mar 16, 2016	AA	RX	No	No
Noven Pharms Inc	XELSTRYM	dextroamphetamine	SYSTEM;TRANSDERMAL	215401-002	Mar 22, 2022		RX	Yes	No			Y
Winder Labs Llc	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate	TABLET;ORAL	212160-005	Jun 7, 2021	AA	RX	No	No

International Patents for dextroamphetamine

Country	Patent Number	Title	Estimated Expiration
Spain	2596809
Mexico	2016008207	COMPOSICIONES Y METODOS PARA LA ADMINISTRACION TRANSDERMICA DE ANFETAMINA. (COMPOSITIONS AND METHODS FOR TRANSDERMAL DELIVERY OF AMPHETAMINE.)
Taiwan	202241397	Transdermal amphetamine compositions with low levels of carbamate
European Patent Office	3086783	COMPOSITIONS ET PROCÉDÉS POUR L'ADMINISTRATION TRANSDERMIQUE D'AMPHÉTAMINE (COMPOSITIONS AND METHODS FOR TRANSDERMAL DELIVERY OF AMPHETAMINE)
European Patent Office	4274555	COMPOSITIONS TRANSDERMIQUES D'AMPHÉTAMINE À FAIBLES TAUX DE CARBAMATE (TRANSDERMAL AMPHETAMINE COMPOSITIONS WITH LOW LEVELS OF CARBAMATE)
Canada	2934924	COMPOSITIONS ET PROCEDES POUR L'ADMINISTRATION TRANSDERMIQUE D'AMPHETAMINE (COMPOSITIONS AND METHODS FOR TRANSDERMAL DELIVERY OF AMPHETAMINE)