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, Actavis Labs Fl Inc, Teva, Takeda Pharms Usa, Actavis Elizabeth, Ani Pharms, Ascent Pharms Inc, Aurolife Pharma Llc, Elite Labs Inc, Endo Operations, Granules, Impax Labs, Lannett Co Inc, Nesher Pharms, Rhodes Pharms, Specgx Llc, Sun Pharm Inds Inc, Sun Pharm Industries, Teva Pharms Usa, Barr Labs Inc, Teva Womens, Accord Hlthcare, Alkem Labs Ltd, Alvogen, Barr, Cediprof Inc, Epic Pharma Llc, Norvium Bioscience, Nuvo Pharm, Oryza, Sandoz, Teva Pharms, Zydus Pharms, Ucb Inc, Azurity, Amneal Pharms, Bionpharma, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Lannett, Novast Labs, Prinston Inc, Sanaluz, Senores Pharms, and Tris Pharma Inc, and is included in sixty-nine NDAs. There are twenty-one 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:	21
Tradenames:	31
Applicants:	46
NDAs:	69
Drug Master File Entries:	55
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	167
Patent Applications:	6,871
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 Zurich	Phase 1
Stephen Robert Marder	Phase 2
Virginia Commonwealth University	Phase 2

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
Zydus Pharms	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	TABLET;ORAL	207340-007	Oct 31, 2017	AB	RX	No	No
Specgx Llc	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	211546-003	Aug 31, 2023	AB2	RX	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	076536-005	Feb 12, 2013		DISCN	No	No
Epic Pharma Llc	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	TABLET;ORAL	040444-007	Nov 3, 2014	AB	RX	No	No
Oryza	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	TABLET;ORAL	210293-005	Apr 3, 2020	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	206340-002	Feb 5, 2016	AB	RX	No	No
Elite Labs Inc	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	TABLET;ORAL	211352-001	Dec 7, 2018	AB	RX	No	No

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)