PREDNISONE - Generic Drug Details

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What are the generic sources for prednisone and what is the scope of freedom to operate?

Prednisone is the generic ingredient in thirteen branded drugs marketed by Hikma, Xttrium Labs Inc, Muro, Actavis Labs Fl Inc, Horizon, Halsey, Bayer Pharms, Pharmacia And Upjohn, Ferndale Labs, Schering, Solvay, Parke Davis, Schwarz Pharma, Allied, Am Therap, Amneal, Amneal Pharms Ny, Aurobindo Pharma Ltd, Bundy, Chartwell Molecular, Chartwell Rx, Contract Pharmacal, Duramed Pharms Barr, Elkins Sinn, Endo Operations, Everylife, Ferrante, Geneyork Pharms, Heather, Hikma Pharms, Impax Labs, Inwood Labs, Ivax Sub Teva Pharms, Jubilant Cadista, Kv Pharm, Lederle, Marshall Pharma, Mutual Pharm, Mylan, Novitium Pharma, Nylos, Panray, Pharmavite, Phoenix Labs Ny, Purepac Pharm, Pvt Form, Rexall, Rising, Roxane, Sandoz, Scherer Labs, Sperti, Strides Pharma, Sun Pharm Industries, Superpharm, Teva, UDL, Upsher Smith, Valeant Pharm Intl, Vangard, Vitarine, Watson Labs, and Whiteworth Town Plsn, and is included in one hundred and twenty-eight NDAs. There are six patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Prednisone has fifty-three patent family members in twenty-nine countries.

There are sixteen drug master file entries for prednisone. Fifty suppliers are listed for this compound.

Summary for PREDNISONE

International Patents:	53
US Patents:	6
Tradenames:	13
Applicants:	63
NDAs:	128
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	50
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	2,021
Patent Applications:	7,466
Drug Prices:	Drug price trends for PREDNISONE
Drug Sales Revenues:	Drug sales revenues for PREDNISONE
What excipients (inactive ingredients) are in PREDNISONE?	PREDNISONE excipients list
DailyMed Link:	PREDNISONE at DailyMed

See drug prices for PREDNISONE

Drug Sales Revenue Trends for PREDNISONE

See drug sales revenues for PREDNISONE

Recent Clinical Trials for PREDNISONE

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

Sponsor	Phase
Zhejiang University	Phase 3
Orion Corporation, Orion Pharma	Phase 3
Merck Sharp & Dohme LLC	Phase 3

See all PREDNISONE clinical trials

Pharmacology for PREDNISONE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for PREDNISONE

Anti-Inflammatory Agents
Antineoplastic Agents, Hormonal
Glucocorticoids

Anatomical Therapeutic Chemical (ATC) Classes for PREDNISONE

A07EA	Corticosteroids acting locally
A07E	INTESTINAL ANTIINFLAMMATORY AGENTS
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

H02AB	Glucocorticoids
H02A	CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02	CORTICOSTEROIDS FOR SYSTEMIC USE
H	Systemic hormonal preparations, excluding sex hormones and insulins

Paragraph IV (Patent) Challenges for PREDNISONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RAYOS	Delayed-release Tablets	prednisone	5 mg	202020	1	2012-11-26

US Patents and Regulatory Information for PREDNISONE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novitium Pharma	PREDNISONE	prednisone	TABLET;ORAL	211575-005	Nov 15, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Strides Pharma	PREDNISONE	prednisone	TABLET;ORAL	208412-005	Nov 20, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs	PREDNISONE	prednisone	TABLET;ORAL	085161-001	Approved Prior to Jan 1, 1982	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-001	Jul 26, 2012	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Everylife	PREDNISONE	prednisone	TABLET;ORAL	084440-002	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs	PREDNISONE	prednisone	TABLET;ORAL	085084-002	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for PREDNISONE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-002	Jul 26, 2012	⤷ Sign Up	⤷ Sign Up
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-001	Jul 26, 2012	⤷ Sign Up	⤷ Sign Up
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-002	Jul 26, 2012	⤷ Sign Up	⤷ Sign Up
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-001	Jul 26, 2012	⤷ Sign Up	⤷ Sign Up
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-001	Jul 26, 2012	⤷ Sign Up	⤷ Sign Up
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-002	Jul 26, 2012	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for PREDNISONE

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Country	Patent Number	Title	Estimated Expiration
Cyprus	1111835		⤷ Sign Up
Hong Kong	1130423	類風濕病的延遲釋放糖皮質激素治療 (DELAYED-RELEASE GLUCOCORTICOID TREATMENT OF RHEUMATOID DISEASE)	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2008015018		⤷ Sign Up
China	1777412	Delayed release tablet with defined core geometry	⤷ Sign Up
Australia	2004231362	Delayed release tablet with defined core geometry	⤷ Sign Up
South Korea	20060015528	DELAYED RELEASE TABLET WITH DEFINED CORE GEOMETRY	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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