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Generated: December 12, 2017

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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, Tris Pharma Inc, Neos Theraps, Teva, Shire, Actavis Elizabeth, Impax Labs, Barr Labs Inc, Shire Dev Llc, Teva Womens, Alvogen Malta, Aurolife Pharma Llc, Barr, Epic Pharma Llc, Mallinckrodt Inc, Mylan Pharms Inc, Nesher Pharms, Sandoz, Sun Pharm Industries, Teva Pharms, Ucb Inc, Lannett, and Arbor Pharms Llc, and is included in twenty-seven 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.

Pharmacology for amphetamine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Alvogen MaltaDEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEamphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateTABLET;ORAL207388-007Jul 28, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
ShireADDERALL XR 20amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateCAPSULE, EXTENDED RELEASE;ORAL021303-002Oct 11, 2001ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Shire Dev LlcMYDAYISamphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateCAPSULE, EXTENDED RELEASE;ORAL022063-002Jun 20, 2017RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
BarrDEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEamphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateTABLET;ORAL040422-005Mar 19, 2003ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Alvogen MaltaDEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEamphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateTABLET;ORAL207388-005Jul 28, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Tris Pharma IncDYANAVEL XRamphetamineSUSPENSION, EXTENDED RELEASE;ORAL208147-001Oct 19, 2015RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Shire Dev LlcMYDAYISamphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateCAPSULE, EXTENDED RELEASE;ORAL022063-003Jun 20, 2017RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Actavis ElizabethDEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEamphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateTABLET;ORAL206340-001Feb 5, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Aurolife Pharma LlcDEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEamphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateTABLET;ORAL202424-004Nov 27, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Neos TherapsADZENYS XR-ODTamphetamineTABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL204326-004Jan 27, 2016RXYesNo► Subscribe► 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
8,202,537Modified release formulations containing drug-ion exchange resin complexes► Subscribe
9,522,191Modified release formulations containing drug--ion exchange resin complexes► Subscribe
9,072,680Compositions comprising methylphenidate complexed with ion-exchange resin particles► 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
8,491,935Modified release formulations containing drug-ion exchange resin complexes► Subscribe
8,790,700Modified release formulations containing drug-ion exchange resin complexes► Subscribe
9,198,864Modified release formulations containing drug-ion exchange resin complexes► Subscribe
9,089,496Compositions comprising methylphenidate complexed with ion-exchange resin particles► Subscribe
9,675,704Modified 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
South Korea101495146► Subscribe
Australia2007227569► Subscribe
World Intellectual Property Organization (WIPO)2007109104► Subscribe
China102488652► Subscribe
Taiwan200812649► Subscribe
European Patent Office2018160► Subscribe
Japan5479086► Subscribe
Denmark2428205► Subscribe
South Korea20080108520► Subscribe
Austria536867► 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:

Boehringer Ingelheim
Baxter
US Department of Justice
Argus Health
Johnson and Johnson
Daiichi Sankyo
Queensland Health
Fuji
Novartis
Cerilliant

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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