PREDNISONE - Generic Drug Details

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What are the generic drug 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, 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, Granulation Tech, 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-nine 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. Forty-nine suppliers are listed for this compound.

Summary for PREDNISONE

International Patents:	53
US Patents:	6
Tradenames:	13
Applicants:	63
NDAs:	129
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	49
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	2,021
Patent Applications:	5,734
Formulation / Manufacturing:	see details
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
Merck Sharp & Dohme LLC	Phase 3
Orion Corporation, Orion Pharma	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
Kv Pharm	PREDNISONE	prednisone	TABLET;ORAL	084236-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma Ltd	PREDNISONE	prednisone	TABLET;ORAL	215672-005	Mar 28, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Panray	PREDNISONE	prednisone	TABLET;ORAL	080350-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Whiteworth Town Plsn	PREDNISONE	prednisone	TABLET;ORAL	089028-001	Jul 24, 1986		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rising	PREDNISONE	prednisone	TABLET;ORAL	089983-001	Jan 12, 1989		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Jubilant Cadista	PREDNISONE	prednisone	TABLET;ORAL	040362-003	Jun 29, 2005	AB	RX	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	202020-001	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	202020-002	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	1113915		⤷ Sign Up
Portugal	1631251		⤷ Sign Up
South Africa	200509477	Delayed release tablet with defined core geometry	⤷ Sign Up
European Patent Office	2049123	TRAITEMENT GLUCOCORTICOÏDIQUE À LIBÉRATION RETARDÉE DE MALADIE RHUMATOÏDE (DELAYED-RELEASE GLUCOCORTICOID TREATMENT OF RHEUMATOID DISEASE)	⤷ Sign Up
Singapore	174026	DELAYED-RELEASE GLUCOCORTICOID TREATMENT OF RHEUMATOID DISEASE	⤷ Sign Up
Norway	20090958		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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