AMPHETAMINE - Generic Drug Details

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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, Lupin, Nesher Pharms, Ph Health, Rhodes Pharms, Specgx Llc, Sun Pharm Inds Inc, Sun Pharm Industries, Teva Pharms Usa, Barr Labs Inc, Teva Womens, Aarxion Anda Hlding, Accord Hlthcare, Alkem Labs Ltd, Alvogen, Barr, Cediprof Inc, Epic Pharma Llc, Nuvo Pharm, Pharmobedient, Sandoz, Teva Pharms, Zydus Pharms, Ucb Inc, Azurity, Amneal Pharms, Bionpharma, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Ingenus Pharms Llc, Lannett, Pharmazone, Prinston Inc, and Tris Pharma Inc, and is included in seventy NDAs. There are twenty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Three suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for AMPHETAMINE

International Patents:	2
US Patents:	21
Tradenames:	31
Applicants:	47
NDAs:	70
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	28
Clinical Trials:	173
Patent Applications:	7,211
Drug Prices:	Drug price trends 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
Massachusetts Institute of Technology (MIT)	PHASE4
Gagan Joshi	PHASE4
Milton S. Hershey Medical Center	PHASE4

See all AMPHETAMINE clinical trials

Generic filers with tentative approvals for AMPHETAMINE

Applicant	Application No.	Strength	Dosage Form
		18.8MG	TABLET, ORALLY DISINTEGRATING;ORAL
		15.7MG	TABLET, ORALLY DISINTEGRATING;ORAL
		12.5MG	TABLET, ORALLY DISINTEGRATING;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 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
Rhodes Pharms	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	TABLET;ORAL	213111-002	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	CAPSULE, EXTENDED RELEASE;ORAL	077302-001	Jun 22, 2012	AB1	RX	No	No
Lannett Co Inc	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	TABLET;ORAL	215565-002	Jul 8, 2022	AB	RX	No	No
Impax Labs	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	076852-005	Feb 16, 2016	AB1	RX	No	No

Expired US Patents for AMPHETAMINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-006	Jan 27, 2016	8,840,924
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-005	Jan 27, 2016	8,840,924
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-003	Jan 27, 2016	8,840,924
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-001	Jan 27, 2016	8,840,924

International Patents for AMPHETAMINE

Country	Patent Number	Title	Estimated Expiration
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)
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)