You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Moodys
McKinsey
Harvard Business School
Dow
Johnson and Johnson
Medtronic

Last Updated: March 29, 2020

DrugPatentWatch Database Preview

Amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate - Generic Drug Details

» See Plans and Pricing

« Back to Dashboard

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.

Summary for amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate
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

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 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 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 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
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

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
Shire ADDERALL XR 25 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 021303-004 May 22, 2002 AB RX Yes No   Start Trial   Start Trial   Start Trial
Amerigen Pharms Ltd DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 205401-003 Jan 22, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Nuvo Pharm DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 209799-001 Dec 28, 2017 AB RX 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 211352-003 Dec 7, 2018 AB RX No No   Start Trial   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 AB RX Yes Yes   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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Moodys
McKinsey
Harvard Business School
Dow
Johnson and Johnson
Medtronic

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.