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Last Updated: August 8, 2020

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METHYLPREDNISOLONE ACETATE - Generic Drug Details

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What are the generic drug sources for methylprednisolone acetate and what is the scope of patent protection?

Methylprednisolone acetate is the generic ingredient in six branded drugs marketed by Pharmacia And Upjohn, Bel Mar, Akorn, Amneal, Sagent Pharms Inc, Sandoz Inc, Teva Pharms Usa, and Watson Labs, and is included in nineteen NDAs. Additional information is available in the individual branded drug profile pages.

There are forty drug master file entries for methylprednisolone acetate. Nine suppliers are listed for this compound.

Drug Sales Revenue Trends for METHYLPREDNISOLONE ACETATE

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Recent Clinical Trials for METHYLPREDNISOLONE ACETATE

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

SponsorPhase
Hadassah Medical OrganizationPhase 2
Northwestern UniversityPhase 4
The University of Texas Medical Branch, GalvestonPhase 2

See all METHYLPREDNISOLONE ACETATE clinical trials

Pharmacology for METHYLPREDNISOLONE ACETATE

US Patents and Regulatory Information for METHYLPREDNISOLONE ACETATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sagent Pharms Inc METHYLPREDNISOLONE ACETATE methylprednisolone acetate INJECTABLE;INJECTION 201835-002 Jun 27, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Sandoz Inc METHYLPREDNISOLONE ACETATE methylprednisolone acetate INJECTABLE;INJECTION 040794-001 Mar 5, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
Amneal METHYLPREDNISOLONE ACETATE methylprednisolone acetate INJECTABLE;INJECTION 210043-002 May 20, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Bel Mar M-PREDROL methylprednisolone acetate INJECTABLE;INJECTION 087135-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Pharmacia And Upjohn MEDROL methylprednisolone acetate ENEMA;RECTAL 018102-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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