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Last Updated: October 6, 2022

Details for Patent: 8,731,963


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Which drugs does patent 8,731,963 protect, and when does it expire?

Patent 8,731,963 protects XYREM and XYWAV and is included in two NDAs.

Protection for XYREM has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

Summary for Patent: 8,731,963
Title:Sensitive drug distribution system and method
Abstract: A drug distribution system and method utilizes a central pharmacy and database to track all prescriptions for a sensitive drug. Information is kept in the database regarding all physicians allowed to prescribe the sensitive drug, and all patients receiving the drug. Abuses are identified by monitoring data in the database for prescription patterns by physicians and prescriptions obtained by patients. Further verification is made that the physician is eligible to prescribe the drug by consulting a separate database, and optionally whether any actions are taken against the physician. Multiple controls beyond those for normal drugs are imposed on the distribution depending on the sensitivity of the drug.
Inventor(s): Reardan; Dayton T. (Shorewood, MN), Engel; Patti A. (Eagan, MN), Gagne; Bob (St. Paul, MN)
Assignee: Jazz Pharmaceuticals, Inc. (Palo Alto, CA)
Application Number:13/592,202
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,731,963
Patent Claim Types:
see list of patent claims
Use; Process;

Drugs Protected by US Patent 8,731,963

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Jazz Pharms XYREM sodium oxybate SOLUTION;ORAL 021196-001 Jul 17, 2002 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Jazz XYWAV calcium oxybate; magnesium oxybate; potassium oxybate; sodium oxybate SOLUTION;ORAL 212690-001 Jul 21, 2020 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Merck
Express Scripts
Mallinckrodt
Harvard Business School
Moodys

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