Amphetamine - Generic Drug Details

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

Amphetamine is the generic ingredient in twenty-six branded drugs marketed by Neos Theraps Inc, Tris Pharma Inc, Neos Theraps, Teva, Takeda Pharms Usa, Actavis Elizabeth, Ani Pharms Inc, Elite Labs Inc, Impax Labs, Mylan, Nesher Pharms, Par Pharm Inc, Rhodes Pharms, Specgx Llc, Sun Pharm Industries, Barr Labs Inc, Teva Womens, Alvogen, Aurolife Pharma Llc, Barr, Epic Pharma Llc, Nuvo Pharm, Sandoz, Teva Pharms, Uspharma, Ucb Inc, Arbor Pharms Llc, Alkem Labs Ltd, Amneal Pharms, Bionpharma Inc, Cerovene Inc, Granules Pharms, Havix, Lannett, Mayne Pharma, Novast Labs, and Prinston Inc, and is included in fifty NDAs. There are sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amphetamine has twenty-three patent family members in fourteen countries.

There are fifty-five drug master file entries for amphetamine. Three suppliers are listed for this compound.

Summary for amphetamine

International Patents:	23
US Patents:	16
Tradenames:	26
Applicants:	37
NDAs:	50
Drug Master File Entries:	55
Suppliers / Packagers:	3
Bulk Api Vendors:	29
Clinical Trials:	157
Patent Applications:	6,535
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

Drug Sales Revenue Trends 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
San Francisco Department of Public Health	Phase 1
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	NDA	Submissiondate
ADZENYS XR-ODT	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	amphetamine	204326	2016-05-10

US Patents and Regulatory Information for amphetamine

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	TABLET;ORAL	206721-006	Nov 10, 2015	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Epic Pharma Llc	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	TABLET;ORAL	040444-005	Nov 3, 2014	AB	RX	No	No	Start Trial	Start Trial				Start Trial
Ani Pharms Inc	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	Start Trial	Start Trial				Start Trial
Takeda Pharms Usa	MYDAYIS	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	022063-004	Jun 20, 2017		RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Neos Theraps	ADZENYS XR-ODT	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	204326-004	Jan 27, 2016		RX	Yes	No	Start Trial	Start Trial	Y			Start Trial
>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 amphetamine

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Country	Patent Number	Estimated Expiration
South Korea	101495146	Start Trial
China	102488652	Start Trial
Japan	5479086	Start Trial
Russian Federation	2435569	Start Trial
European Patent Office	2018160	Start Trial
>Country	>Patent Number	>Estimated Expiration

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