AMPHETAMINE SULFATE - Generic Drug Details

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

Amphetamine sulfate is the generic ingredient in three branded drugs marketed by Azurity, 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 eighteen NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twenty drug master file entries for amphetamine sulfate. Thirteen suppliers are listed for this compound.

Summary for AMPHETAMINE SULFATE

US Patents:	4
Tradenames:	3
Applicants:	17
NDAs:	18
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	24
Clinical Trials:	8
Patent Applications:	1,536
Drug Prices:	Drug price trends for AMPHETAMINE SULFATE
What excipients (inactive ingredients) are in AMPHETAMINE SULFATE?	AMPHETAMINE SULFATE excipients list
DailyMed Link:	AMPHETAMINE SULFATE at DailyMed

See drug prices for AMPHETAMINE SULFATE

Recent Clinical Trials for AMPHETAMINE SULFATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Vallon Pharmaceuticals, Inc.	Phase 1
Arbor Pharmaceuticals, Inc.	Phase 3
Sarah Morrow	Phase 2/Phase 3

See all AMPHETAMINE SULFATE clinical trials

Pharmacology for AMPHETAMINE SULFATE

Drug Class	Central Nervous System Stimulant
Physiological Effect	Central Nervous System Stimulation

US Patents and Regulatory Information for AMPHETAMINE SULFATE

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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
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-003	Jan 30, 2019		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-004	Jan 30, 2019		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glenmark Pharms Ltd	AMPHETAMINE SULFATE	amphetamine sulfate	TABLET;ORAL	212186-002	Jan 27, 2021		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for AMPHETAMINE SULFATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-001	Jan 30, 2019	⤷ Sign Up	⤷ Sign Up
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-003	Jan 30, 2019	⤷ Sign Up	⤷ Sign Up
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-005	Apr 16, 2021	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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