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Serving leading biopharmaceutical companies globally:

Citi
Julphar
Moodys
AstraZeneca
QuintilesIMS
Baxter
Express Scripts
Harvard Business School
Cerilliant
US Department of Justice

Generated: February 19, 2018

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, 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, Mylan Pharms Inc, Nesher Pharms, Sandoz, Specgx Llc, Sun Pharm Industries, Sunrise Pharm Inc, Teva Pharms, Ucb Inc, Lannett, and Arbor Pharms Llc, and is included in twenty-eight 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 amphetamine

US Patents and Regulatory Information for amphetamine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 077488-003 Apr 29, 2013 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Barr DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 040422-002 Feb 11, 2002 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sandoz DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 040439-004 Sep 27, 2002 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Teva DELCOBESE amphetamine adipate; amphetamine sulfate; dextroamphetamine adipate; dextroamphetamine sulfate TABLET;ORAL 083563-003 Approved Prior to Jan 1, 1982 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Teva DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 077488-004 Apr 29, 2013 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Neos Theraps ADZENYS XR-ODT amphetamine TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL 204326-004 Jan 27, 2016 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Tris Pharma Inc DYANAVEL XR amphetamine SUSPENSION, EXTENDED RELEASE;ORAL 208147-001 Oct 19, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Sun Pharm Industries DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 040480-005 Sep 9, 2003 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Barr Labs Inc DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate CAPSULE, EXTENDED RELEASE;ORAL 076536-005 Feb 12, 2013 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Barr DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate TABLET;ORAL 040422-001 Feb 11, 2002 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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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Non-Orange Book US Patents for 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
9,198,864 Modified release formulations containing drug-ion exchange resin complexes ➤ Sign Up
9,072,680 Compositions comprising methylphenidate complexed with ion-exchange resin particles ➤ Sign Up
8,790,700 Modified release formulations containing drug-ion exchange resin complexes ➤ Sign Up
8,202,537 Modified release formulations containing drug-ion exchange resin complexes ➤ Sign Up
9,549,989 Modified release formulations containing drug-ion exchange resin complexes ➤ Sign Up
9,089,496 Compositions comprising methylphenidate complexed with ion-exchange resin particles ➤ Sign Up
8,491,935 Modified release formulations containing drug-ion exchange resin complexes ➤ Sign Up
9,522,191 Modified release formulations containing drug--ion exchange resin complexes ➤ Sign Up
9,675,704 Modified release formulations containing drug-ion exchange resin complexes ➤ Sign Up
9,839,619 Method for treating ADD or ADHD comprising administering amphetamine complexed with ion-exchange resin particles ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for amphetamine

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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Chubb
Federal Trade Commission
Citi
Johnson and Johnson
Julphar
Fish and Richardson
Mallinckrodt
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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