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Last Updated: May 17, 2024

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, Am Therap, Amneal, Amneal Pharms Ny, Aurobindo Pharma Ltd, Bundy, Chartwell Molecular, Chartwell Rx, Contract Pharmacal, Duramed Pharms Barr, Elkins Sinn, 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, Vintage Pharms, 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:	1,993
Patent Applications:	7,518
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

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Recent Clinical Trials for PREDNISONE

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

Sponsor	Phase
MacroGenics	Phase 2
Philippe Armand, MD, PhD	Phase 2
Liaoning Tumor Hospital & Institute	Phase 2

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

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
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-002	Jul 26, 2012	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Amneal	PREDNISONE	prednisone	TABLET;ORAL	213385-002	Jun 16, 2020	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Ferndale Labs	FERNISONE	prednisone	TABLET;ORAL	083364-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Aurobindo Pharma Ltd	PREDNISONE	prednisone	TABLET;ORAL	215671-001	Nov 16, 2021	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Pharmacia And Upjohn	DELTASONE	prednisone	TABLET;ORAL	009986-005	Approved Prior to Jan 1, 1982		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Granulation Tech	PREDNISONE	prednisone	TABLET;ORAL	212629-002	Dec 5, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>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	202020-003	Jul 26, 2012	⤷ Try a Trial	⤷ Try a Trial
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-002	Jul 26, 2012	⤷ Try a Trial	⤷ Try a Trial
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-001	Jul 26, 2012	⤷ Try a Trial	⤷ Try a Trial
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-002	Jul 26, 2012	⤷ Try a Trial	⤷ Try a Trial
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-001	Jul 26, 2012	⤷ Try a Trial	⤷ Try a Trial
Horizon	RAYOS	prednisone	TABLET, DELAYED RELEASE;ORAL	202020-002	Jul 26, 2012	⤷ Try a Trial	⤷ Try a Trial
>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
Spain	2368066		⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2004093843		⤷ Try a Trial
Ukraine	96457	ЛЕЧЕНИЕ РЕВМАТОИДНОГО АРТРИТА ГЛЮКОКОРТИКОИДАМИ С ОТСРОЧЕННЫМ ВЫСВОБОЖДЕНИЕМ;ЛІКУВАННЯ РЕВМАТОЇДНОГО АРТРИТУ ГЛЮКОКОРТИКОЇДАМИ З ВІДСТРОЧЕНИМ ВИВІЛЬНЕННЯМ (DELAYED-RELEASE GLUCOCORTICOID TREATMENT OF RHEUMATOID DISEASE)	⤷ Try a Trial
Cyprus	1111835		⤷ Try a Trial
Japan	2009545546		⤷ Try a Trial
Malaysia	149863	DELAYED-RELEASE GLUCOCORTICOID TREATMENT OF RHEUMATOID DISEASE	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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