DEXTROAMPHETAMINE - Generic Drug Details

✉ Email this page to a colleague

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

Dextroamphetamine is the generic ingredient in seven branded drugs marketed by Noven Pharms Inc, 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-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:	7
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

Generic Entry Date for DEXTROAMPHETAMINE^: ⤷ Sign Up* 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
The Beckwith Institute	Phase 4
Eva Szigethy	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
⤷ Sign Up	⤷ Sign Up	30MG	CAPSULE, EXTENDED RELEASE;ORAL
⤷ Sign Up	⤷ Sign Up	25MG	CAPSULE, EXTENDED RELEASE;ORAL
⤷ Sign Up	⤷ Sign Up	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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lannett	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate	TABLET;ORAL	083903-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Azurity	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate	TABLET;ORAL	090533-006	Oct 25, 2011	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Noven Pharms Inc	XELSTRYM	dextroamphetamine	SYSTEM;TRANSDERMAL	215401-004	Mar 22, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Noven Pharms Inc	XELSTRYM	dextroamphetamine	SYSTEM;TRANSDERMAL	215401-004	Mar 22, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Noven Pharms Inc	XELSTRYM	dextroamphetamine	SYSTEM;TRANSDERMAL	215401-001	Mar 22, 2022		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for DEXTROAMPHETAMINE

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
Australia	2014370133	Compositions and methods for transdermal delivery of amphetamine	⤷ Sign Up
Canada	3203041	COMPOSITIONS TRANSDERMIQUES D'AMPHETAMINE A FAIBLES TAUX DE CARBAMATE (TRANSDERMAL AMPHETAMINE COMPOSITIONS WITH LOW LEVELS OF CARBAMATE)	⤷ Sign Up
China	116997330	具有低水平氨基甲酸盐的透皮安非他命组合物 (Transdermal buamphetamine compositions with low levels of carbamates)	⤷ Sign Up
Mexico	2007004315	DISPOSITIVO PARA SUMINISTRO TRANSDERMICO DE FARMACO QUE INCLUYE UN RESPALDO OCLUSIVO. (TRANSDERMAL DRUG DELIVERY DEVICE INCLUDING AN OCCLUSIVE BACKING.)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2022150430		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.