Details for New Drug Application (NDA): 202020

NDA 202020 describes RAYOS, which is a drug marketed by Horizon and is included in one NDA. It is available from one supplier. There are two 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-eight suppliers are listed for this compound. Additional details are available on the prednisone profile page.

Summary for 202020

Tradename:	RAYOS
Applicant:	Horizon
Ingredient:	prednisone
Patents:	2

Pharmacology for NDA: 202020

Mechanism of Action

Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for 202020

Anti-Inflammatory Agents

Antineoplastic Agents, Hormonal

Glucocorticoids

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 Therapeutics USA, 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 Therapeutics USA, Inc.	75987-020	75987-020-02	1 BOTTLE in 1 CARTON (75987-020-02) / 100 TABLET, DELAYED RELEASE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	1MG
Approval Date:	Jul 26, 2012	TE:		RLD:	Yes
Patent:	9,504,699	Patent Expiration:	Aug 3, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF DISEASES OR CONDITIONS BY THE USE OF A DELAYED-RELEASE 1,2, OR 5MG PREDNISONE TABLET

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	2MG
Approval Date:	Jul 26, 2012	TE:		RLD:	Yes
Patent:	9,504,699	Patent Expiration:	Aug 3, 2027	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF DISEASES OR CONDITIONS BY THE USE OF A DELAYED-RELEASE 1,2, OR 5MG PREDNISONE TABLET

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	5MG
Approval Date:	Jul 26, 2012	TE:		RLD:	Yes
Patent:	8,168,218	Patent Expiration:	Jan 7, 2028	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF RHEUMATOLOGIC, ALLERGIC, PULMONARY,GASTROINTESTINAL,DERMATOLOGIC DISEASES OR CONDITIONS BY THE USE OF A DELAYED RELEASE 5MG PREDNISONE TABLET

Expired US Patents for NDA 202020

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-002	Jul 26, 2012	6,677,326
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-001	Jul 26, 2012	6,488,960
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-003	Jul 26, 2012	9,186,332
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-001	Jul 26, 2012	9,040,085
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-003	Jul 26, 2012	9,040,085
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-003	Jul 26, 2012	8,394,407
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-001	Jul 26, 2012	9,186,332

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