AMPHETAMINE - Generic Drug Details

What are the generic 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, Granules, Impax Labs, Lannett Co Inc, Nesher Pharms, Par Pharm Inc, 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, Mylan, Nuvo Pharm, Sandoz, Teva Pharms, Uspharma Windlas, Zydus Pharms, Ucb Inc, Azurity, Amneal Pharms, Bionpharma, Cerovene Inc, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Lannett, Novast Labs, Prinston Inc, Senores Pharms, and Tris Pharma Inc, and is included in sixty-nine NDAs. There are twenty 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:	20
Tradenames:	31
Applicants:	46
NDAs:	69
Drug Master File Entries:	55
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	166
Patent Applications:	6,868
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
Stephen Robert Marder	Phase 2
Virginia Commonwealth University	Phase 2
Boston Children's Hospital	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
Takeda Pharms Usa	ADDERALL XR 5	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-005	May 22, 2002	AB1	RX	Yes	No
Teva Pharms	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	TABLET;ORAL	040472-001	Sep 30, 2003		DISCN	No	No
Teva	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	077488-003	Apr 29, 2013		DISCN	No	No
Elite Labs Inc	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	212037-002	Dec 11, 2019	AB1	RX	No	No
Ascent Pharms Inc	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	TABLET;ORAL	213709-005	Apr 22, 2021	AB	RX	No	No
Tris Pharma Inc	DYANAVEL XR 15	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526-003	Nov 4, 2021		RX	Yes	No			Y
Tris Pharma Inc	DYANAVEL XR 10	amphetamine; amphetamine aspartate/dextroamphetamine sulfate	TABLET, EXTENDED RELEASE;ORAL	210526-002	Nov 4, 2021		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)