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Last Updated: January 26, 2021

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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 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 Inc, Elite Labs Inc, Impax Labs, Mylan, Nesher Pharms, Par Pharm Inc, Rhodes Pharms, Specgx Llc, Sun Pharm Industries, Teva, Barr Labs Inc, Teva Womens, Alvogen, Aurolife Pharma Llc, Barr, Epic Pharma Llc, Nuvo Pharm, Sandoz, Teva Pharms, and Uspharma, and is included in thirty NDAs. There are four 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-nine patent family members in thirty countries.

There are fifty-five drug master file entries for amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate. Twenty-six 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 NDA Submissiondate
MYDAYIS CAPSULE, EXTENDED RELEASE;ORAL amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate 022063 2017-08-07
MYDAYIS CAPSULE, EXTENDED RELEASE;ORAL amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate 022063 2017-08-03
ADDERALL 7.5 TABLET;ORAL amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate 011522 2009-11-18
ADDERALL 20 TABLET;ORAL amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate 011522 2009-11-18
ADDERALL 10 TABLET;ORAL amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate 011522 2009-11-18
ADDERALL 30 TABLET;ORAL amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate 011522 2009-11-18
ADDERALL 12.5 TABLET;ORAL amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate 011522 2009-11-18
ADDERALL 5 TABLET;ORAL amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate 011522 2009-11-18
ADDERALL 15 TABLET;ORAL amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate 011522 2009-11-18
ADDERALL XR 25 CAPSULE, EXTENDED RELEASE;ORAL amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate 021303
ADDERALL XR 10 CAPSULE, EXTENDED RELEASE;ORAL amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate 021303
ADDERALL XR 30 CAPSULE, EXTENDED RELEASE;ORAL amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate 021303
ADDERALL XR 15 CAPSULE, EXTENDED RELEASE;ORAL amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate 021303
ADDERALL XR 5 CAPSULE, EXTENDED RELEASE;ORAL amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate 021303
ADDERALL XR 20 CAPSULE, EXTENDED RELEASE;ORAL amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate 021303

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
Elite Labs Inc DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 211352-001 Dec 7, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Uspharma DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 210293-006 Apr 3, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 206721-003 Nov 10, 2015 AB RX No No   Start Trial   Start Trial   Start 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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