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Last Updated: January 17, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202020

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NDA 202020 describes RAYOS, which is a drug marketed by Horizon Pharma Usa and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug and one Paragraph IV challenge. Additional details are available on the RAYOS profile page.

The generic ingredient in RAYOS is prednisone. There are sixteen drug master file entries for this compound. Forty-two suppliers are listed for this compound. Additional details are available on the prednisone profile page.
Summary for 202020
Tradename:RAYOS
Applicant:Horizon Pharma Usa
Ingredient:prednisone
Patents:8
Formulation / Manufacturing:see details
Pharmacology for NDA: 202020
Medical Subject Heading (MeSH) Categories for 202020
Suppliers and Packaging for NDA: 202020
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
RAYOS prednisone TABLET, DELAYED RELEASE;ORAL 202020 NDA Horizon Pharma Inc. 75987-020 75987-020-01 1 BOTTLE in 1 CARTON (75987-020-01) > 30 TABLET, DELAYED RELEASE in 1 BOTTLE
RAYOS prednisone TABLET, DELAYED RELEASE;ORAL 202020 NDA Horizon Pharma Inc. 75987-020 75987-020-02 1 BOTTLE in 1 CARTON (75987-020-02) > 100 TABLET, DELAYED RELEASE in 1 BOTTLE
Paragraph IV (Patent) Challenges for 202020
Tradename Dosage Ingredient NDA Submissiondate
RAYOS TABLET, DELAYED RELEASE;ORAL prednisone 202020 2012-11-26

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength1MG
Approval Date:Jul 26, 2012TE:ABRLD:Yes
Patent:  Start TrialPatent Expiration:Mar 14, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF RHEUMATOID ARTHRITIS BY DELAYED RELEASE FORMULATION OF 1MG OR 2MG OF PREDNISONE
Patent:  Start TrialPatent Expiration:Mar 14, 2020Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF PULMONARY, GASTROINTESTINAL AND/OR RHEUMATOLOGICAL DISEASES OR CONDITIONS BY USE OF DELAYED RELEASE FORMULATIONS OF 1MG OR 2MG PREDNISONE
Patent:  Start TrialPatent Expiration:Apr 23, 2024Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF DISEASES OR CONDITIONS BY THE USE OF A DELAYED RELEASE 1, 2, OR 5 MG PREDNISONE TABLET

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Serving leading biopharmaceutical companies globally:

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