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Serving leading biopharmaceutical companies globally:

Teva
Express Scripts
Mallinckrodt
Daiichi Sankyo
UBS
Fish and Richardson
Moodys
Novartis
Cantor Fitzgerald
US Army

Generated: October 22, 2017

DrugPatentWatch Database Preview

Amphetamine - Generic Drug Details

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What are the generic drug sources for amphetamine and what is the scope of amphetamine patent protection?

Amphetamine
is the generic ingredient in twenty-five branded drugs marketed by Neos Theraps Inc, Neos Theraps, Tris Pharma Inc, Teva, 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, Alvogen Malta, Ucb Inc, Lannett, and Arbor Pharms Llc, and is included in twenty-six NDAs. There are nineteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Amphetamine has twenty-three patent family members in fourteen countries.

There are fifty-three drug master file entries for amphetamine. Two suppliers are listed for this compound.

Summary for Generic Name: amphetamine

US Patents:19
Tradenames:25
Applicants:22
NDAs:26
Drug Master File Entries: see list53
Suppliers / Packagers: see list2
Bulk Api Vendors: see list25
Clinical Trials: see list127
Patent Applications: see list8,731
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:amphetamine at DailyMed

Pharmacology for Ingredient: amphetamine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Tris Pharma Inc
DYANAVEL XR
amphetamine
SUSPENSION, EXTENDED RELEASE;ORAL208147-001Oct 19, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Mallinckrodt Inc
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate
TABLET;ORAL040440-003Oct 7, 2003ABRXNoNo► Subscribe► Subscribe► Subscribe
Tris Pharma Inc
DYANAVEL XR
amphetamine
SUSPENSION, EXTENDED RELEASE;ORAL208147-001Oct 19, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Barr
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate
TABLET;ORAL040422-006Mar 19, 2003ABRXNoNo► Subscribe► Subscribe► Subscribe
Alvogen Malta
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate
TABLET;ORAL207388-004Jul 28, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Sandoz
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate
TABLET;ORAL040439-001Jun 14, 2002ABRXNoNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate
TABLET;ORAL040480-002Sep 9, 2003ABRXNoNo► Subscribe► Subscribe► Subscribe
Neos Theraps
ADZENYS XR-ODT
amphetamine
TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL204326-002Jan 27, 2016RXYesNo► Subscribe► SubscribeY ► Subscribe
Shire
ADDERALL XR 10
amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate
CAPSULE, EXTENDED RELEASE;ORAL021303-001Oct 11, 2001ABRXYesNo► Subscribe► SubscribeY► Subscribe
Teva Womens
ADDERALL 12.5
amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate
TABLET;ORAL011522-012Aug 31, 2000DISCNYesNo► Subscribe► SubscribeY► Subscribe
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Non-Orange Book Patents for Generic Ingredient: amphetamine

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,072,680Compositions comprising methylphenidate complexed with ion-exchange resin particles► Subscribe
9,198,864Modified release formulations containing drug-ion exchange resin complexes► Subscribe
8,337,890Modified release formulations containing drug-ion exchange resin complexes► Subscribe
9,549,989Modified release formulations containing drug-ion exchange resin complexes► Subscribe
9,675,704Modified release formulations containing drug-ion exchange resin complexes► Subscribe
8,491,935Modified release formulations containing drug-ion exchange resin complexes► Subscribe
8,790,700Modified release formulations containing drug-ion exchange resin complexes► Subscribe
8,202,537Modified release formulations containing drug-ion exchange resin complexes► Subscribe
9,089,496Compositions comprising methylphenidate complexed with ion-exchange resin particles► Subscribe
9,522,191Modified release formulations containing drug--ion exchange resin complexes► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: amphetamine

Country Document Number Estimated Expiration
Denmark2018160► Subscribe
Canada2645855► Subscribe
Russian Federation2435569► Subscribe
South Korea101495146► Subscribe
Australia2007227569► Subscribe
World Intellectual Property Organization (WIPO)2013003622► Subscribe
Japan2009530298► Subscribe
Taiwan200812649► Subscribe
World Intellectual Property Organization (WIPO)2007109104► Subscribe
Israel194042► 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:

Daiichi Sankyo
Cantor Fitzgerald
QuintilesIMS
Medtronic
UBS
Johnson and Johnson
AstraZeneca
Federal Trade Commission
Harvard Business School
Mallinckrodt

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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