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Serving leading biopharmaceutical companies globally:

Accenture
Queensland Health
Healthtrust
Harvard Business School
Boehringer Ingelheim
Express Scripts
Merck
Cantor Fitzgerald
Fuji
Cipla

Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for Patent: RE42096

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Which drugs does patent RE42096 protect, and when does it expire?


Patent RE42096 protects MYDAYIS, ADDERALL XR 10, ADDERALL XR 15, ADDERALL XR 20, ADDERALL XR 25, ADDERALL XR 30, and ADDERALL XR 5, and is included in two NDAs. There have been two Paragraph IV challenges on Mydayis.

Protection for ADDERALL XR 10 has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has ten patent family members in eight countries.

Summary for Patent: RE42096

Title:Oral pulsed dose drug delivery system
Abstract: A multiple pulsed dose drug delivery system for pharmaceutically active amphetamine salts, comprising an immediate-release component and an enteric delayed-release component wherein (1) the enteric release coating has a defined minimum thickness and/or (2) there is a protective layer between the pharmaceutically active amphetamine salt and the enteric release coating and/or (3) there is a protective layer over the enteric release coating. The product can be composed of either one of a number of beads in a dosage form, including either capsule, tablet, or sachet method for administering the beads.
Inventor(s): Burnside; Beth A. (Bethesda, MD), Guo; Xiaodi (Apex, NC), Fiske; Kimberly (Downingtow, PA), Couch; Richard A. (Bryn Mawr, PA), Chang; Rong-Kun (Rockville, MD), Treacy; Donald J. (Woodbine, MD), McGuiness; Charlotte M. (Bethesda, MD), Rudnic; Edward M. (North Potomac, MD)
Assignee: Shire LLC, USA (N/A)
Application Number:11/091,011
Patent Claim Types:
see list of patent claims
Composition; Delivery;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Patent Submitted
Shire Dev LlcMYDAYISamphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateCAPSULE, EXTENDED RELEASE;ORAL022063-001Jun 20, 2017RXYesNo► Subscribe► SubscribeY► Subscribe
Shire Dev LlcMYDAYISamphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateCAPSULE, EXTENDED RELEASE;ORAL022063-002Jun 20, 2017RXYesNo► Subscribe► SubscribeY► Subscribe
Shire Dev LlcMYDAYISamphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateCAPSULE, EXTENDED RELEASE;ORAL022063-003Jun 20, 2017RXYesNo► Subscribe► SubscribeY► Subscribe
Shire Dev LlcMYDAYISamphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateCAPSULE, EXTENDED RELEASE;ORAL022063-004Jun 20, 2017RXYesNo► Subscribe► SubscribeY► Subscribe
ShireADDERALL XR 10amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateCAPSULE, EXTENDED RELEASE;ORAL021303-001Oct 11, 2001ABRXYesNo► Subscribe► SubscribeY► Subscribe
ShireADDERALL XR 15amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateCAPSULE, EXTENDED RELEASE;ORAL021303-006May 22, 2002ABRXYesNo► Subscribe► SubscribeY► Subscribe
ShireADDERALL XR 20amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateCAPSULE, EXTENDED RELEASE;ORAL021303-002Oct 11, 2001ABRXYesNo► Subscribe► SubscribeY► Subscribe
ShireADDERALL XR 25amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateCAPSULE, EXTENDED RELEASE;ORAL021303-004May 22, 2002ABRXYesNo► Subscribe► SubscribeY► Subscribe
ShireADDERALL XR 30amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateCAPSULE, EXTENDED RELEASE;ORAL021303-003Oct 11, 2001ABRXYesYes► Subscribe► SubscribeY► Subscribe
ShireADDERALL XR 5amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfateCAPSULE, EXTENDED RELEASE;ORAL021303-005May 22, 2002ABRXYesNo► Subscribe► SubscribeY► Subscribe
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Non-Orange Book Patents for Patent: RE42096

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
6,322,819 Oral pulsed dose drug delivery system► Subscribe
RE41148Oral pulsed dose drug delivery system► Subscribe
6,605,300 Oral pulsed dose drug delivery system► 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 Patent: RE42096

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria427101► Subscribe
Australia1214500► Subscribe
Canada2348090► Subscribe
Germany69940673► Subscribe
European Patent Office1123087► Subscribe
European Patent Office1977736► Subscribe
Spain2323910► Subscribe
Japan2002527468► Subscribe
Japan2008303223► Subscribe
World Intellectual Property Organization (WIPO)0023055► 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:

Healthtrust
QuintilesIMS
US Department of Justice
Citi
Julphar
Cipla
Deloitte
Moodys
Merck
Fish and Richardson

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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