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Details for Patent: 6,605,300

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Patent 6,605,300 protects ADDERALL XR 10, ADDERALL XR 15, ADDERALL XR 20, ADDERALL XR 25, ADDERALL XR 30, and ADDERALL XR 5, and is included in one NDA.

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: 6,605,300

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 or a number of beads in a dosage form, including either capsule, tablet, or sachet method for administering the beads.
Inventor(s): Burnside; Beth A. (Silver Spring, MD), Guo; Xiaodi (Derwood, MD), Fiske; Kimberly (Alexandria, VA), Couch; Richard A. (Bethesda, MD), Treacy; Donald J. (Arnold, MD), Chang; Rong-Kun (Hockessin, DE), McGuinness; Charlotte M. (Bethesda, MD), Rudnic; Edward M. (North Potomac, MD)
Assignee: Shire Laboratories, Inc. (Rockville, MD)
Application Number:09/807,462
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Dosage form; Delivery;
Patent Metrics:
Source: PatentQuant.com
Field: Pharmaceuticals
Back Citations: 30th percentile
Forward Citations: 3rd percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Shire
ADDERALL XR 10
amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate
CAPSULE, EXTENDED RELEASE;ORAL021303-001Oct 11, 2001RXNo6,605,300*PED► subscribeY
Shire
ADDERALL XR 15
amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate
CAPSULE, EXTENDED RELEASE;ORAL021303-006May 22, 2002RXNo6,605,300*PED► subscribeY
Shire
ADDERALL XR 20
amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate
CAPSULE, EXTENDED RELEASE;ORAL021303-002Oct 11, 2001RXNo6,605,300*PED► subscribeY
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Foreign Priority and PCT Information for Patent: 6,605,300

PCT Information
PCT FiledOctober 20, 1999PCT Application Number:PCT/US99/24554
PCT Publication Date:April 27, 2000PCT Publication Number: WO00/23055

Non-Orange Book Patents for Patent: 6,605,300

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
RE41148Oral pulsed dose drug delivery system► subscribe
6,322,819 Oral pulsed dose drug delivery system► subscribe
RE42096Oral 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: 6,605,300

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Austria427101► subscribe
Australia1214500► subscribe
Canada2348090► 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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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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