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Chinese Patent Office
Medtronic
UBS
Baxter
Daiichi Sankyo
Deloitte
Farmers Insurance
Dow
Citi
Boehringer Ingelheim

Generated: October 18, 2017

DrugPatentWatch Database Preview

Details for Patent: 6,228,398

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Which drugs does patent 6,228,398 protect, and when does it expire?


Patent 6,228,398 protects FOCALIN XR, ZOHYDRO ER, and RITALIN LA, and is included in three NDAs. There have been zero Paragraph IV challenges on Focalin XR, , and .

This patent has one hundred and forty patent family members in thirty-three countries.

Summary for Patent: 6,228,398

Title: Multiparticulate modified release composition
Abstract:The invention relates to a multiparticulate modified release composition that in operation delivers an active ingredient in a pulsed or bimodal manner. The multiparticulate modified release composition comprises an immediate release component and a modified release component; the immediate release component comprising a first population of active ingredient containing particles and the modified release component compnsimg a second population of active ingredient containing particles coated with a controlled release coating; wherein the combination of the immediate release and modified release components in operation deliver the active ingredient in a pulsed or a bimodal manner. The invention also relates to a solid oral dosage form containing such a multiparticulate modified release composition. The plasma profile achieved by the multiparticulate modified release composition is advantageous in reducing patient tolerance to the active ingredient and in increasing patient compliance by reducing dosage frequency.
Inventor(s): Devane; John G. (Athlone, IE), Stark; Paul (Athlone, IE), Fanning; Niall M. M. (Athlone, IE)
Assignee: Elan Corporation, PLC (Dublin, IE)
Application Number:09/566,636
Patent Claim Types:
see list of patent claims
Composition; Delivery; Formulation; Dosage form; Use;

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-001May 26, 2005ABRXYesNo► Subscribe► SubscribeY METHOD OF TREATING ATTENTION DEFICIT DISORDER USING ORAL ADMINISTRATION OF A BI-MODAL OR PULSATILE RELEASE COMPOSITION
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-002May 26, 2005ABRXYesNo► Subscribe► SubscribeY METHOD OF TREATING ATTENTION DEFICIT DISORDER USING ORAL ADMINISTRATION OF A BI-MODAL OR PULSATILE RELEASE COMPOSITION
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-004Aug 1, 2006ABRXYesNo► Subscribe► SubscribeY METHOD OF TREATING ATTENTION DEFICIT DISORDER USING ORAL ADMINISTRATION OF A BI-MODAL OR PULSATILE RELEASE COMPOSITION
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-003May 26, 2005ABRXYesNo► Subscribe► SubscribeY METHOD OF TREATING ATTENTION DEFICIT DISORDER USING ORAL ADMINISTRATION OF A BI-MODAL OR PULSATILE RELEASE COMPOSITION
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-008Apr 21, 2011ABRXYesNo► Subscribe► SubscribeY METHOD OF TREATING ATTENTION DEFICIT DISORDER USING ORAL ADMINISTRATION OF A BI-MODAL OR PULSATILE RELEASE COMPOSITION
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-005Oct 23, 2009ABRXYesNo► Subscribe► SubscribeY METHOD OF TREATING ATTENTION DEFICIT DISORDER USING ORAL ADMINISTRATION OF A BI-MODAL OR PULSATILE RELEASE COMPOSITION
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-007Apr 21, 2011ABRXYesNo► Subscribe► SubscribeY METHOD OF TREATING ATTENTION DEFICIT DISORDER USING ORAL ADMINISTRATION OF A BI-MODAL OR PULSATILE RELEASE COMPOSITION
Novartis
FOCALIN XR
dexmethylphenidate hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL021802-006Aug 11, 2010ABRXYesYes► Subscribe► SubscribeY METHOD OF TREATING ATTENTION DEFICIT DISORDER USING ORAL ADMINISTRATION OF A BI-MODAL OR PULSATILE RELEASE COMPOSITION
Pernix Ireland Pain
ZOHYDRO ER
hydrocodone bitartrate
CAPSULE, EXTENDED RELEASE;ORAL202880-001Oct 25, 2013RXYesYes► Subscribe► SubscribeY
Pernix Ireland Pain
ZOHYDRO ER
hydrocodone bitartrate
CAPSULE, EXTENDED RELEASE;ORAL202880-002Oct 25, 2013RXYesNo► Subscribe► SubscribeY
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Non-Orange Book Patents for Patent: 6,228,398

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
8,119,163Nanoparticulate and controlled release compositions comprising cefditoren► Subscribe
6,730,325 Multiparticulate modified release composition► Subscribe
6,902,742 Multiparticulate modified release composition► Subscribe
7,580,712Wireless high-speed data network planning tool► Subscribe
6,793,936 Multiparticulate modified release composition► 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: 6,228,398

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Germany112006001606► Subscribe
Denmark1126826► Subscribe
Eurasian Patent Organization200701195► Subscribe
Eurasian Patent Organization200702595► Subscribe
Eurasian Patent Organization200800092► Subscribe
European Patent Office1126826► Subscribe
European Patent Office1889501► Subscribe
European Patent Office1901718► Subscribe
Turkey200101216► Subscribe
Slovakia287674► 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:

Federal Trade Commission
Chubb
AstraZeneca
Covington
Cantor Fitzgerald
Farmers Insurance
McKesson
Fuji
US Department of Justice
Boehringer Ingelheim

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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