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Last Updated: July 14, 2020

DrugPatentWatch Database Preview

ORASONE Drug Profile


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Which patents cover Orasone, and when can generic versions of Orasone launch?

Orasone is a drug marketed by Solvay and is included in two NDAs.

The generic ingredient in ORASONE is prednisone. There are sixteen drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the prednisone profile page.

US ANDA Litigation and Generic Entry Outlook for Orasone

A generic version of ORASONE was approved as prednisone by WATSON LABS on December 31st, 1969.

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Summary for ORASONE
Drug patent expirations by year for ORASONE
Recent Clinical Trials for ORASONE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Mayo ClinicPhase 1
OHSU Knight Cancer InstitutePhase 2
Oregon Health and Science UniversityPhase 2

See all ORASONE clinical trials

US Patents and Regulatory Information for ORASONE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Solvay ORASONE prednisone TABLET;ORAL 083009-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Solvay ORASONE prednisone TABLET;ORAL 083009-004 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Solvay ORASONE prednisone TABLET;ORAL 083009-002 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Solvay ORASONE prednisone TABLET;ORAL 083009-003 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Solvay ORASONE prednisone TABLET;ORAL 085999-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Merck
McKesson
Moodys
AstraZeneca
Boehringer Ingelheim
Johnson and Johnson

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