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Details for Patent: 7,879,349

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Patent 7,879,349 protects NASCOBAL and is included in one NDA.

Summary for Patent: 7,879,349

Title:Cyanocobalamin low viscosity aqueous formulations for intranasal delivery
Abstract: A stable pharmaceutical mercury-free aqueous solution of cyanocobalamin comprised of cyanocobalamin and water wherein said solution of cyanocobalamin is suitable for intranasal administration, has a viscosity less than about 1000 cPs, and wherein said solution of cyanocobalamin has a bioavailability of cyanocobalamin when administered intranasally of at least about 7% relative to an intramuscular injection of cyanocobalamin with the proviso that the solution is essentially free of mercury and mercury-containing compounds. The present invention is also directed towards a method for elevating the vitamin B12 levels in the cerebral spinal fluid (CSF) comprising administering intranasally a sufficient amount of a mercury-free cyanocobalamin solution so as to increase the average ratio of vitamin B12 in the CSF to that in the blood serum (B12 CSF/B12 Serum.times.100) to at least about 1.1 comprising intranasally administering an aqueous solution of a cyanocobalamin, wherein said solution of cyanocobalamin has a bioavailability of at least 7% relative to an intramuscular injection of a cyanocobalamin.
Inventor(s): Quay; Steven C. (Edmonds, WA), Aprile; Peter C. (East Northport, NY), Go; Zenaida O. (Clifton, NJ), Sileno; Anthony P. (Brookhaven Hamlet, NY)
Assignee: Par Pharmaceutical, Inc. (Woodcliff Lake, NJ)
Application Number:12/079,875
Patent Claim Types:
see list of patent claims
Formulation; Compound; Use;
Patent Metrics:
Source: PatentQuant.com
Field: Medical technology
Back Citations: 37th percentile
Forward Citations: 0th percentile

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Endo Pharms Inc
NASCOBAL
cyanocobalamin
SPRAY, METERED;NASAL021642-001Jan 31, 2005RXYes7,879,349► subscribeY CYANOCOBALAMIN ADMINISTRATION THROUGH NASAL INFUSION
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Non-Orange Book Patents for Patent: 7,879,349

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
8,940,714Cyanocobalamin low viscosity aqueous formulations for intranasal delivery► subscribe
7,229,636Cyanocobalamin low viscosity aqueous formulations for intranasal delivery► subscribe
7,404,489Cyanocobalamin low viscosity aqueous formulations for intranasal delivery► 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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