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Last Updated: June 27, 2022

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 seventeen branded drugs marketed by Takeda Pharms Usa, Ascent Pharms Inc, Lannett Co Inc, Actavis Elizabeth, Ani Pharms, Aurolife Pharma Llc, Elite Labs Inc, Impax Labs, Nesher Pharms, Par Pharm Inc, Rhodes Pharms, Specgx Llc, Sun Pharm Industries, Teva, Teva Pharms Usa, Barr Labs Inc, Teva Womens, Accord Hlthcare, Alvogen, Barr, Epic Pharma Llc, Granules, Mylan, Nuvo Pharm, Sandoz, Teva Pharms, Uspharma Windlas, and Zydus Pharms, and is included in thirty-seven 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-eight 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
Takeda Pharms Usa ADDERALL XR 15 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303-006 May 22, 2002 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Specgx Llc DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 040440-007 Oct 7, 2003 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Aurolife Pharma Llc DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 202424-005 Nov 27, 2013 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Takeda Pharms Usa MYDAYIS amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063-001 Jun 20, 2017 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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

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

Country Patent Number Title Estimated Expiration
Austria 495731 See Plans and Pricing
Poland 375991 Przedłużone uwalnianie soli amfetaminy (SUSTAINED RELEASED DELIVERY OF AMPHETAMINE SALTS) See Plans and Pricing
Iceland 7818 Tafin losun á amfetamínsöltum See Plans and Pricing
Germany 60335807 See Plans and Pricing
>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.