Amphetamine - Generic Drug Details

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

Amphetamine is the generic ingredient in thirty-one branded drugs marketed by Neos Theraps Inc, Neos Theraps, Teva, Rhodes Pharms, Takeda Pharms Usa, Ascent Pharms Inc, Lannett Co Inc, Actavis Elizabeth, Ani Pharms, Aurolife Pharma Llc, Elite Labs Inc, Impax Labs, Nesher Pharms, Par Pharm Inc, Specgx Llc, Sun Pharm Industries, Teva Pharms Usa, Barr Labs Inc, Teva Womens, Accord Hlthcare, Alvogen, Barr, Cediprof Inc, Epic Pharma Llc, Granules, Mylan, Nuvo Pharm, Sandoz, Teva Pharms, Uspharma Windlas, Zydus Pharms, Ucb Inc, Azurity, Alkem Labs Ltd, Amneal Pharms, Bionpharma Inc, Cerovene Inc, Glenmark Pharms Ltd, Lannett, Mayne Pharma, Novast Labs, Prinston Inc, Rise Pharma, Sun Pharm Inds Inc, Arbor Pharms Llc, and Tris Pharma Inc, and is included in sixty-four NDAs. There are eighteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amphetamine has two patent family members in two countries.

There are fifty-five drug master file entries for amphetamine. One supplier is listed for this compound.

Summary for amphetamine

International Patents:	2
US Patents:	18
Tradenames:	31
Applicants:	46
NDAs:	64
Drug Master File Entries:	55
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	162
Patent Applications:	6,815
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for amphetamine
Drug Sales Revenues:	Drug sales revenues for amphetamine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for amphetamine
What excipients (inactive ingredients) are in amphetamine?	amphetamine excipients list
DailyMed Link:	amphetamine at DailyMed

See drug prices for amphetamine

See drug sales revenues for amphetamine

Recent Clinical Trials for amphetamine

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

Sponsor	Phase
University of Alabama at Birmingham	Phase 4
University of California, San Francisco	Phase 2
University of California, Los Angeles	Early Phase 1

See all amphetamine clinical trials

Pharmacology for amphetamine

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

Medical Subject Heading (MeSH) Categories for amphetamine

Adrenergic Agents

Adrenergic Uptake Inhibitors

Central Nervous System Stimulants

Dopamine Agents

Dopamine Uptake Inhibitors

Sympathomimetics

Paragraph IV (Patent) Challenges for AMPHETAMINE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ADZENYS XR-ODT	Extended-release Orally Disintegrating Tablets	amphetamine	3.1 mg, 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, 18.8 mg	204326	1	2016-05-10

US Patents and Regulatory Information for amphetamine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Actavis Elizabeth	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	TABLET;ORAL	206340-005	Feb 5, 2016	AB	RX	No	No
Aurolife Pharma Llc	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	211876-003	Jun 24, 2020		DISCN	No	No
Barr Labs Inc	DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	076536-006	Feb 12, 2013		DISCN	No	No
Rhodes Pharms	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	amphetamine aspartate ; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	TABLET;ORAL	213111-003	Jan 13, 2021	AB	RX	No	No
Actavis Elizabeth	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	TABLET;ORAL	040456-002	May 6, 2003		DISCN	No	No
Ani Pharms	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	205401-001	Jan 22, 2019	AB	RX	No	No
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-004	Jan 27, 2016		RX	Yes	No			Y

International Patents for amphetamine

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2013003622
European Patent Office	2726066	FORMES POSOLOGIQUES POUR ADMINISTRATION ORALE ET MÉTHODES DE TRAITEMENT LES UTILISANT (DOSAGE FORMS FOR ORAL ADMINISTRATION AND METHODS OF TREATMENT USING THE SAME)