AMPHETAMINE Drug Patent Profile

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Amphetamine is a drug marketed by Actavis Labs Fl Inc, Alkem Labs Ltd, Amneal Pharms, Aurolife Pharma Llc, Bionpharma, Cerovene Inc, Dr Reddys Labs Sa, Epic Pharma Llc, Glenmark Pharms Ltd, Granules, Lannett, Novast Labs, Prinston Inc, Rhodes Pharms, Senores Pharms, Specgx Llc, and Sun Pharm Inds Inc. and is included in seventeen NDAs.

The generic ingredient in AMPHETAMINE is amphetamine sulfate. There are fifty-five drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the amphetamine sulfate profile page.

A generic version of AMPHETAMINE was approved as amphetamine sulfate by AMNEAL PHARMS on September 26^th, 2018.

US Patents:	0
Applicants:	17
NDAs:	17
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	166
Patent Applications:	4,370
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for AMPHETAMINE
Drug Sales Revenues:	Drug sales revenues for AMPHETAMINE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for AMPHETAMINE
DailyMed Link:	AMPHETAMINE at DailyMed

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

Adrenergic Agents
Adrenergic Uptake Inhibitors
Central Nervous System Stimulants
Dopamine Agents
Dopamine Uptake Inhibitors
Sympathomimetics

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

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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
Rhodes Pharms	AMPHETAMINE SULFATE	amphetamine sulfate	TABLET;ORAL	213852-002	Sep 7, 2021	AA	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Novast Labs	AMPHETAMINE SULFATE	amphetamine sulfate	TABLET;ORAL	213763-002	Aug 24, 2020		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Senores Pharms	AMPHETAMINE SULFATE	amphetamine sulfate	TABLET;ORAL	212901-001	May 22, 2020	AA	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Prinston Inc	AMPHETAMINE SULFATE	amphetamine sulfate	TABLET;ORAL	211861-001	Mar 11, 2020	AA	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Actavis Labs Fl Inc	AMPHETAMINE	amphetamine	TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL	209253-001	Jun 22, 2023		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Dr Reddys Labs Sa	AMPHETAMINE SULFATE	amphetamine sulfate	TABLET;ORAL	213898-002	Jul 14, 2020		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Granules	AMPHETAMINE SULFATE	amphetamine sulfate	TABLET;ORAL	212619-002	Aug 5, 2019	AA	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration