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Serving leading biopharmaceutical companies globally:

Merck
Cantor Fitzgerald
Harvard Business School
Fuji
Chubb
Covington
Colorcon
Mallinckrodt
US Department of Justice
Farmers Insurance

Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for Patent: 8,236,285

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Which drugs does patent 8,236,285 protect, and when does it expire?

Patent 8,236,285 protects ZOLPIMIST and is included in one NDA.

This patent has eighty-eight patent family members in ten countries.

This patent has expired prematurely due to non-payment of maintenance fees. See details below.
Summary for Patent: 8,236,285
Title:Buccal, polar and non-polar spray containing zolpidem
Abstract: Buccal aerosol sprays or capsules using polar and non-polar solvents have now been developed which provide zolpidem for rapid absorption through the oral mucosa, resulting in fast onset of effect. The buccal polar compositions of the invention comprise formulation I: aqueous polar solvent, zolpidem, and optional flavoring agent; formulation II: aqueous polar solvent, zolpidem, optionally flavoring agent, and propellant; formulation III: non-polar solvent, zolpidem, and optional flavoring agent; formulation IV: non-polar solvent, zolpidem, optional flavoring agent, and propellant; formulation V: a mixture of a polar solvent and a non-polar solvent, zolpidem, and optional flavoring agent; formulation VI: a mixture of a polar solvent and a non-polar solvent, zolpidem, optional flavoring agent, and propellant.
Inventor(s): Dugger, III; Harry A. (Flemington, NJ), Abd El-Shafy; Mohammed (Hauppauge, NY)
Assignee: Novadel Pharma Inc. (Flemington, NJ)
Application Number:12/576,457
Patent Claim Types:
see list of patent claims
Use; Composition;

Drugs Protected by US Patent 8,236,285

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
Magna Pharms ZOLPIMIST zolpidem tartrate SPRAY, METERED;ORAL 022196-001 Dec 19, 2008 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y TREATMENT OF TRANSIENT INSOMNIA ➤ Sign Up
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

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Non-Orange Book US Patents Family Members for Patent 8,236,285

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
6,676,931 Buccal, polar and non-polar spray or capsule ➤ Sign Up
6,998,110 Buccal, polar and non-polar spray or capsule ➤ Sign Up
7,632,517 Buccal, polar and non-polar spray containing zolpidem ➤ Sign Up
9,078,816 Buccal, polar and non-polar spray containing ondansetron ➤ Sign Up
6,969,508 Buccal, polar and non-polar spray or capsule containing drugs for treating pain ➤ Sign Up
6,977,070 Buccal, polar and non-polar spray or capsule containing drugs for treating disorders of the central nervous system ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents Family Members for US Patent 8,236,285

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2003262916 ➤ Sign Up
Australia 2003262917 ➤ Sign Up
Australia 2003270014 ➤ Sign Up
Australia 2003270016 ➤ Sign Up
Australia 2003270017 ➤ Sign Up
Australia 2003270018 ➤ Sign Up
Australia 2003272242 ➤ Sign Up
Australia 2003296899 ➤ Sign Up
Australia 2003298564 ➤ Sign Up
Australia 4894697 ➤ Sign Up
Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Accenture
Johnson and Johnson
Queensland Health
Farmers Insurance
US Department of Justice
AstraZeneca
Cerilliant
Boehringer Ingelheim

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