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Last Updated: November 13, 2019

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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 Shire, Par Pharm Inc, Actavis Elizabeth, Amerigen Pharms Ltd, Impax Labs, Nesher Pharms, Rhodes Pharms, Specgx Llc, Sun Pharm Industries, Teva, Barr Labs Inc, Shire Dev Llc, Teva Womens, Alvogen, Aurolife Pharma Llc, Barr, Epic Pharma Llc, Mylan, Nuvo Pharm, Sandoz, Sungen Pharma, and Teva Pharms, and is included in twenty-seven NDAs. There are eight 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 forty-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-five suppliers are listed for this compound.

Recent Litigation for AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

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District Court Litigation
Case NameDate
Shire Development LLC v. SpecGx LLC2018-05-25
ADAMAS PHARMA, LLC v. SANDOZ INC.2018-05-10
Shire Development LLC v. Impax Laboratories LLC2018-04-13

See all AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE litigation

PTAB Litigation
PetitionerDate
KVK-Tech, Inc.2017-12-11
Amerigen Pharmaceuticals Limited2017-01-13
Mylan Pharmaceuticals Inc.2016-10-04

See all AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE litigation

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
Nesher Pharms DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 207340-001 Oct 31, 2017 AB RX No No   Start Trial   Start Trial   Start 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 076536-002 Feb 12, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Sandoz DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 040439-003 Jun 14, 2002 AB RX No No   Start Trial   Start Trial   Start Trial
Teva Pharms DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 040472-001 Sep 30, 2003 DISCN No No   Start Trial   Start Trial   Start Trial
Sungen Pharma DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 211352-002 Dec 7, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Actavis Elizabeth DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 077302-002 Jun 22, 2012 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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