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Last Updated: April 29, 2024

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, Sun Pharm Inds Inc, and Arbor Pharms Llc, 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. Fourteen suppliers are listed for this compound.

Summary for AMPHETAMINE SULFATE

US Patents:	4
Tradenames:	3
Applicants:	18
NDAs:	18
Drug Master File Entries:	20
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	24
Clinical Trials:	8
Patent Applications:	1,536
Formulation / Manufacturing:	see details
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
Sun Pharm Inds Inc	AMPHETAMINE SULFATE	amphetamine sulfate	TABLET;ORAL	214574-002	Jan 27, 2021	AA	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Amneal Pharms	AMPHETAMINE SULFATE	amphetamine sulfate	TABLET;ORAL	211139-002	Sep 26, 2018	AA	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Amneal Pharms	AMPHETAMINE SULFATE	amphetamine sulfate	TABLET;ORAL	211139-001	Sep 26, 2018	AA	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-002	Jan 30, 2019		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-001	Jan 30, 2019		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Specgx Llc	AMPHETAMINE SULFATE	amphetamine sulfate	TABLET;ORAL	213583-002	Jan 22, 2021	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

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	209905-004	Jan 30, 2019	⤷ Try a Trial	⤷ Try a Trial
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-005	Apr 16, 2021	⤷ Try a Trial	⤷ Try a Trial
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-001	Jan 30, 2019	⤷ Try a Trial	⤷ Try a Trial
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-003	Jan 30, 2019	⤷ Try a Trial	⤷ Try a Trial
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-002	Jan 30, 2019	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.