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Last Updated: March 29, 2024

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 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
Ani Pharms DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 205401-002 Jan 22, 2019 AB1 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Elite Labs Inc DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 212037-003 Dec 11, 2019 AB1 RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Barr DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 040422-003 Feb 11, 2002 AB RX 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 215771-007 Dec 28, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Ascent Pharms Inc DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 214959-001 Sep 29, 2021 AB1 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.