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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Teva
Julphar
Argus Health
Cantor Fitzgerald
Dow
Healthtrust
Harvard Business School
QuintilesIMS
Accenture

Generated: December 14, 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, RITALIN LA, and ZOHYDRO ER, 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 Patent Submitted Product Substance Delist Req. Patented / Exclusive Use
NovartisFOCALIN XRdexmethylphenidate hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL021802-001May 26, 2005ABRXYesNo► Subscribe► Subscribe► SubscribeYMETHOD OF TREATING ATTENTION DEFICIT DISORDER USING ORAL ADMINISTRATION OF A BI-MODAL OR PULSATILE RELEASE COMPOSITION
NovartisFOCALIN XRdexmethylphenidate hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL021802-002May 26, 2005ABRXYesNo► Subscribe► Subscribe► SubscribeYMETHOD OF TREATING ATTENTION DEFICIT DISORDER USING ORAL ADMINISTRATION OF A BI-MODAL OR PULSATILE RELEASE COMPOSITION
NovartisFOCALIN XRdexmethylphenidate hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL021802-004Aug 1, 2006ABRXYesNo► Subscribe► Subscribe► SubscribeYMETHOD OF TREATING ATTENTION DEFICIT DISORDER USING ORAL ADMINISTRATION OF A BI-MODAL OR PULSATILE RELEASE COMPOSITION
NovartisFOCALIN XRdexmethylphenidate hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL021802-003May 26, 2005ABRXYesNo► Subscribe► Subscribe► SubscribeYMETHOD OF TREATING ATTENTION DEFICIT DISORDER USING ORAL ADMINISTRATION OF A BI-MODAL OR PULSATILE RELEASE COMPOSITION
NovartisFOCALIN XRdexmethylphenidate hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL021802-008Apr 21, 2011ABRXYesNo► Subscribe► Subscribe► SubscribeYMETHOD OF TREATING ATTENTION DEFICIT DISORDER USING ORAL ADMINISTRATION OF A BI-MODAL OR PULSATILE RELEASE COMPOSITION
NovartisFOCALIN XRdexmethylphenidate hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL021802-005Oct 23, 2009ABRXYesNo► Subscribe► Subscribe► SubscribeYMETHOD OF TREATING ATTENTION DEFICIT DISORDER USING ORAL ADMINISTRATION OF A BI-MODAL OR PULSATILE RELEASE COMPOSITION
NovartisFOCALIN XRdexmethylphenidate hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL021802-007Apr 21, 2011ABRXYesNo► Subscribe► Subscribe► SubscribeYMETHOD OF TREATING ATTENTION DEFICIT DISORDER USING ORAL ADMINISTRATION OF A BI-MODAL OR PULSATILE RELEASE COMPOSITION
NovartisFOCALIN XRdexmethylphenidate hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL021802-006Aug 11, 2010ABRXYesYes► Subscribe► Subscribe► SubscribeYMETHOD OF TREATING ATTENTION DEFICIT DISORDER USING ORAL ADMINISTRATION OF A BI-MODAL OR PULSATILE RELEASE COMPOSITION
NovartisRITALIN LAmethylphenidate hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL021284-004Apr 10, 2004AB1RXYesNo► Subscribe► Subscribe► SubscribeYTREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER USING METHYLPHENIDATE BI-MODAL RELEASE PROFILE EXTENDED-RELEASE CAPSULES
NovartisRITALIN LAmethylphenidate hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL021284-001Jun 5, 2002AB1RXYesNo► Subscribe► Subscribe► SubscribeYTREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER USING METHYLPHENIDATE BI-MODAL RELEASE PROFILE EXTENDED-RELEASE CAPSULES
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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
6,730,325 Multiparticulate modified release composition► Subscribe
7,580,712Wireless high-speed data network planning tool► Subscribe
8,119,163Nanoparticulate and controlled release compositions comprising cefditoren► Subscribe
6,902,742 Multiparticulate modified release composition► 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
Mexico2008016115► Subscribe
Japan2009541360► Subscribe
Japan2009541359► Subscribe
Japan2009517485► Subscribe
Japan2009516636► Subscribe
Japan2009514989► Subscribe
Japan2008546781► Subscribe
Japan2008545808► Subscribe
China101484169► Subscribe
China101484170► 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:

Julphar
Queensland Health
Medtronic
Accenture
McKinsey
Federal Trade Commission
Argus Health
Mallinckrodt
Boehringer Ingelheim
Dow

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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