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Last Updated: March 28, 2024

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


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What are the generic drug sources for amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate and what is the scope of patent protection?

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 two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Twenty-seven suppliers are listed for this compound.

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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 077488-003 Apr 29, 2013 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rhodes Pharms DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 213111-003 Jan 13, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurolife Pharma Llc DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 211876-006 Jun 24, 2020 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Granules DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 215771-005 Dec 28, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Specgx Llc DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 211546-004 Aug 31, 2023 AB2 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 aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate

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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.