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Details for Patent: 9,326,966

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Patent 9,326,966 protects RAVICTI and is included in one NDA. There has been one Paragraph IV challenge on Ravicti.

This patent has eleven patent family members in eleven countries.

Summary for Patent: 9,326,966

Title:Methods of therapeutic monitoring of nitrogen scavenging drugs
Abstract: The present disclosure provides methods for evaluating daily ammonia exposure based on a single fasting ammonia blood level measurement, as well as methods that utilize this technique to adjust the dosage of a nitrogen scavenging drug, determine whether to administer a nitrogen scavenging drug, and treat nitrogen retention disorders.
Inventor(s): Scharschmidt; Bruce (San Francisco, CA), Mokhtarani; Masoud (Walnut Creek, CA)
Assignee: Horizon Therapeutics, Inc. (Lake Forest, IL)
Application Number:14/958,259
Patent Claim Types:
see list of patent claims
Use; Delivery;

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Horizon Theraps Inc
RAVICTI
glycerol phenylbutyrate
LIQUID;ORAL203284-001Feb 1, 2013RXYes9,326,966► subscribe TREATMENT OF A UREA CYCLE DISORDER
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Non-Orange Book Patents for Patent: 9,326,966

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
8,404,215Methods of therapeutic monitoring of nitrogen scavenging► subscribe
9,254,278Methods of therapeutic monitoring of nitrogen scavenging drugs► subscribe
9,095,559Methods of therapeutic monitoring of nitrogen scavenging drugs► 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: 9,326,966

Country Document Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Singapore11201400781T► subscribe
Mexico2014003854► subscribe
South Korea20140094517► 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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