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Last Updated: January 24, 2020

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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 sixteen branded drugs marketed by Shire, Actavis Elizabeth, Amerigen Pharms Ltd, Impax Labs, Nesher Pharms, Par Pharm Inc, Rhodes Pharms, Specgx Llc, Sun Pharm Industries, Sungen Pharma, Teva, Barr Labs Inc, Shire Dev Llc, Teva Womens, Alvogen, Aurolife Pharma Llc, Barr, Epic Pharma Llc, Mylan, Nuvo Pharm, Sandoz, and Teva Pharms, and is included in twenty-eight 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.

Summary for AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
International Patents:49
US Patents:8
Tradenames:16
Applicants:22
NDAs:28
Drug Master File Entries: 55
Suppliers / Packagers: 25
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
DailyMed Link:AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE at DailyMed
Recent Litigation for AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Identify potential future generic entrants

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
Drug ClassCentral Nervous System Stimulant
Physiological EffectCentral Nervous System Stimulation
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

Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Elizabeth DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 077302-001 Jun 22, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Teva DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 077488-002 Apr 29, 2013 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 TABLET;ORAL 206340-001 Feb 5, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Shire Dev Llc MYDAYIS amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063-002 Jun 20, 2017 RX Yes No   Start Trial   Start Trial Y   Start Trial
Nesher Pharms DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 207340-006 Oct 31, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Impax Labs DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 076852-003 Feb 16, 2016 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Expired US Patents for AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Shire ADDERALL XR 20 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303-002 Oct 11, 2001   Start Trial   Start Trial
Shire ADDERALL XR 5 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303-005 May 22, 2002   Start Trial   Start Trial
Shire ADDERALL XR 10 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303-001 Oct 11, 2001   Start Trial   Start Trial
Shire Dev Llc MYDAYIS amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063-004 Jun 20, 2017   Start Trial   Start Trial
Shire ADDERALL XR 5 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303-005 May 22, 2002   Start Trial   Start Trial
Shire ADDERALL XR 30 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303-003 Oct 11, 2001   Start Trial   Start Trial
Shire Dev Llc MYDAYIS amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 022063-002 Jun 20, 2017   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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International Patents for AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Country Patent Number Estimated Expiration
World Intellectual Property Organization (WIPO) 0105407   Start Trial
Japan 2002527468   Start Trial
European Patent Office 1202739   Start Trial
South Korea 20050084589   Start Trial
European Patent Office 1542660   Start Trial
World Intellectual Property Organization (WIPO) 2004028509   Start Trial
Cyprus 1112335   Start Trial
>Country >Patent Number >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 verifification 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.

 
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