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Last Updated: November 29, 2023

Amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate - Generic Drug Details

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

Amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate is the generic ingredient in sixteen branded drugs marketed by Takeda Pharms Usa, Actavis Elizabeth, Ani Pharms, Ascent Pharms Inc, Aurolife Pharma Llc, Elite Labs Inc, Granules, Impax Labs, Lannett Co Inc, Nesher Pharms, Par Pharm Inc, Rhodes Pharms, Specgx Llc, Sun Pharm Inds Inc, Sun Pharm Industries, Teva, Teva Pharms Usa, Barr Labs Inc, Teva Womens, Accord Hlthcare, Alkem Labs Ltd, Alvogen, Barr, Cediprof Inc, Epic Pharma Llc, Mylan, Nuvo Pharm, Sandoz, Teva Pharms, Uspharma Windlas, and Zydus Pharms, and is included in forty-three NDAs. There are three patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate has thirty-three patent family members in thirty countries.

Twenty-nine suppliers are listed for this compound.

Summary for amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate

International Patents:	33
US Patents:	3
Tradenames:	16
Applicants:	31
NDAs:	43
Finished Product Suppliers / Packagers:	29
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate
DailyMed Link:	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate at DailyMed

Pharmacology for amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate

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

Paragraph IV (Patent) Challenges for AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MYDAYIS	Extended-release Capsules	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	12.5 mg and 25 mg	022063	1	2017-08-07
MYDAYIS	Extended-release Capsules	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	37.5 mg and 50 mg	022063	1	2017-08-03
ADDERALL 7.5	Tablets	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	5 mg, 10 mg, 20 mg, 30 mg	011522	1	2009-11-18

US Patents and Regulatory Information for amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine 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
Takeda Pharms Usa	MYDAYIS	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	022063-003	Jun 20, 2017	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Sun Pharm Industries	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	TABLET;ORAL	040480-003	Sep 9, 2003	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lannett Co Inc	DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	TABLET;ORAL	215565-006	Jul 8, 2022	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Barr Labs Inc	DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	076536-006	Feb 12, 2013		DISCN	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 aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Takeda Pharms Usa	MYDAYIS	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	022063-002	Jun 20, 2017	⤷ Try a Trial	⤷ Try a Trial
Takeda Pharms Usa	ADDERALL XR 20	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-002	Oct 11, 2001	⤷ Try a Trial	⤷ Try a Trial
Takeda Pharms Usa	ADDERALL XR 15	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	021303-006	May 22, 2002	⤷ Try a Trial	⤷ Try a Trial
Takeda Pharms Usa	MYDAYIS	amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate	CAPSULE, EXTENDED RELEASE;ORAL	022063-003	Jun 20, 2017	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate

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Country	Patent Number	Title	Estimated Expiration
Ecuador	SP055702	ADMINISTRACIÓN DE SALES DE ANFETAMINA DE LIBERACIÓN SOSTENIDA	⤷ Try a Trial
Spain	2360046		⤷ Try a Trial
African Regional IP Organization (ARIPO)	2030	Sustained released delivery of amphetamine salts	⤷ Try a Trial
Norway	20051986		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated 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.