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Generated: November 18, 2017

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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 amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate freedom to operate?

Amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate
is the generic ingredient in sixteen branded drugs marketed by Actavis Elizabeth, Shire, Mylan Pharms Inc, Teva Womens, Barr, Aurolife Pharma Llc, Barr Labs Inc, Sandoz, Mallinckrodt Inc, Epic Pharma Llc, Impax Labs, Shire Dev Llc, Teva Pharms, Sun Pharm Inds, Teva, and Alvogen Malta, and is included in eighteen NDAs. There are ten 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-three drug master file entries for amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate. Twenty-one suppliers are listed for this compound.

Summary for AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE

Pharmacology 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
Actavis Elizabeth
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate
TABLET;ORAL040456-004May 6, 2003ABRXNoNo► Subscribe► Subscribe► Subscribe
Shire Dev Llc
MYDAYIS
amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate
CAPSULE, EXTENDED RELEASE;ORAL022063-004Jun 20, 2017RXYesNo► Subscribe► SubscribeY ► Subscribe
Shire
ADDERALL XR 20
amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate
CAPSULE, EXTENDED RELEASE;ORAL021303-002Oct 11, 2001ABRXYesNo► Subscribe► Subscribe ► Subscribe
Actavis Elizabeth
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate
TABLET;ORAL206340-003Feb 5, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Shire
ADDERALL XR 25
amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate
CAPSULE, EXTENDED RELEASE;ORAL021303-004May 22, 2002ABRXYesNo► Subscribe► Subscribe ► Subscribe
Mallinckrodt Inc
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate
TABLET;ORAL040440-006Oct 7, 2003ABRXNoNo► Subscribe► Subscribe► Subscribe
Shire Dev Llc
MYDAYIS
amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate
CAPSULE, EXTENDED RELEASE;ORAL022063-003Jun 20, 2017RXYesNo► Subscribe► SubscribeY ► Subscribe
Shire
ADDERALL XR 20
amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate
CAPSULE, EXTENDED RELEASE;ORAL021303-002Oct 11, 2001ABRXYesNo► Subscribe► Subscribe ► Subscribe
Teva Womens
ADDERALL 20
amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate
TABLET;ORAL011522-008Feb 13, 1996DISCNYesNo► Subscribe► SubscribeY► Subscribe
Sun Pharm Inds
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate
TABLET;ORAL040480-004Sep 9, 2003ABRXNoNo► Subscribe► Subscribe► Subscribe
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International Patent Family for Ingredient: amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate

Country Document Number Estimated Expiration
Ukraine87812► Subscribe
European Patent Office1202739► Subscribe
Canada2499546► Subscribe
Australia1214500► Subscribe
European Patent Office1123087► Subscribe
Canada2348090► Subscribe
World Intellectual Property Organization (WIPO)2004028509► Subscribe
Cyprus1112335► Subscribe
African Intellectual Property Organization (OAPI)13075► Subscribe
European Patent Office1977736► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

Queensland Health
Federal Trade Commission
Boehringer Ingelheim
US Army
Baxter
Chinese Patent Office
Fuji
Dow
Covington
Cipla

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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