Methylprednisolone acetate - Generic Drug Details

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What are the generic drug sources for methylprednisolone acetate and what is the scope of freedom to operate?

Methylprednisolone acetate is the generic ingredient in six branded drugs marketed by Pharmacia And Upjohn, Pfizer, Bel Mar, Amneal, Endo Operations, Epic Pharma Llc, Eugia Pharma, Hong Kong, Sagent Pharms Inc, Sandoz, Teva Pharms Usa, Watson Labs, and Wilshire Pharms Inc, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for methylprednisolone acetate. Twelve suppliers are listed for this compound.

Sponsor	Phase
Menoufia University	N/A
Centre hospitalier de l'Université de Montréal (CHUM)	Phase 4
Yale University	Phase 2

Sponsor

Phase

Menoufia University

N/A

Centre hospitalier de l'Université de Montréal (CHUM)

Phase 4

Yale University

Phase 2

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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
Amneal	METHYLPREDNISOLONE ACETATE	methylprednisolone acetate	INJECTABLE;INJECTION	216502-002	Nov 3, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal	METHYLPREDNISOLONE ACETATE	methylprednisolone acetate	INJECTABLE;INJECTION	210043-002	May 20, 2019	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bel Mar	M-PREDROL	methylprednisolone acetate	INJECTABLE;INJECTION	087135-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal	METHYLPREDNISOLONE ACETATE	methylprednisolone acetate	INJECTABLE;INJECTION	216502-001	Nov 3, 2023	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

US Patents:	0
Tradenames:	6
Applicants:	13
NDAs:	23
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	38
Patent Applications:	6,855
Drug Prices:	Drug price trends for methylprednisolone acetate
What excipients (inactive ingredients) are in methylprednisolone acetate?	methylprednisolone acetate excipients list
DailyMed Link:	methylprednisolone acetate at DailyMed

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists