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Last Updated: September 22, 2020

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Details for Patent: 10,314,788

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Summary for Patent: 10,314,788
Title:Pharmaceutical compositions configured to deter dosage form splitting
Abstract: An oral pharmaceutical composition comprising a drug and one or more pharmaceutically acceptable excipients in a monolithic dosage form, wherein the dosage form is configured such that when the dosage form is divided into more than one piece and at least one of the pieces is administered to a subject the Cmax, AUC, and/or rate of drug released after administration is substantially the same or lower and the Tmax is higher than the Cmax, AUC, rate of drug released, and/or Tmax after administration of: (1) a comparable composition in intact dosage form of equal drug dosage of the administered at least one piece; (2) a bioequivalent drug composition in an intact dosage form of equal drug dosage to the administered at least one piece; and (3) a divided piece of a bioequivalent drug composition, wherein the divided piece comprises a drug dosage equal to the dosage of the administered piece of the oral composition. Methods of making the same and methods of using the same are also provided.
Inventor(s): Shah; Manish S. (Valley Cottage, NY), Difalco; Ray J. (Valley Cottage, NY)
Assignee: INSPIRION DELIVERY SCIENCES LLC (Basking Ridge, NJ)
Application Number:13/058,757
Patent Claim Types:
see list of patent claims
Composition; Dosage form;

Drugs Protected by US Patent 10,314,788

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Daiichi Sankyo Inc MORPHABOND ER morphine sulfate TABLET, EXTENDED RELEASE;ORAL 206544-001 Oct 2, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
Daiichi Sankyo Inc MORPHABOND ER morphine sulfate TABLET, EXTENDED RELEASE;ORAL 206544-002 Oct 2, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
Daiichi Sankyo Inc MORPHABOND ER morphine sulfate TABLET, EXTENDED RELEASE;ORAL 206544-003 Oct 2, 2015 RX Yes No   Start Trial   Start Trial Y   Start Trial
Daiichi Sankyo Inc MORPHABOND ER morphine sulfate TABLET, EXTENDED RELEASE;ORAL 206544-004 Oct 2, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Ohemo Life ROXYBOND oxycodone hydrochloride TABLET;ORAL 209777-001 Apr 20, 2017 DISCN No No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

Foreign Priority and PCT Information for Patent: 10,314,788

PCT Information
PCT FiledFebruary 12, 2009PCT Application Number:PCT/US2009/033919
PCT Publication Date:February 18, 2010PCT Publication Number: WO2010/019279

International Family Members for US Patent 10,314,788

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2008286914   Start Trial
Australia 2009282376   Start Trial
Australia 2015200009   Start Trial
Australia 2017200414   Start Trial
Australia 2019200895   Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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