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Last Updated: November 2, 2024

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.

Summary for methylprednisolone acetate
Drug Prices for methylprednisolone acetate

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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
Menoufia UniversityN/A
Centre hospitalier de l'Université de Montréal (CHUM)Phase 4
Yale UniversityPhase 2

See all methylprednisolone acetate clinical trials

Pharmacology for methylprednisolone acetate
Anatomical Therapeutic Chemical (ATC) Classes for methylprednisolone acetate
A01AC Corticosteroids for local oral treatment
A01A STOMATOLOGICAL PREPARATIONS
A01 STOMATOLOGICAL PREPARATIONS
A Alimentary tract and metabolism
A07EA Corticosteroids acting locally
A07E INTESTINAL ANTIINFLAMMATORY AGENTS
A07 ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A Alimentary tract and metabolism
C05AA Corticosteroids
C05A AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05 VASOPROTECTIVES
C Cardiovascular system
D07AA Corticosteroids, weak (group I)
D07A CORTICOSTEROIDS, PLAIN
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D07AA Corticosteroids, weak (group I)
D07A CORTICOSTEROIDS, PLAIN
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D07XA Corticosteroids, weak, other combinations
D07X CORTICOSTEROIDS, OTHER COMBINATIONS
D07 CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D Dermatologicals
D10AA Corticosteroids, combinations for treatment of acne
D10A ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10 ANTI-ACNE PREPARATIONS
D Dermatologicals
H02AB Glucocorticoids
H02A CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02 CORTICOSTEROIDS FOR SYSTEMIC USE
H Systemic hormonal preparations, excluding sex hormones and insulins
H02AB Glucocorticoids
H02A CORTICOSTEROIDS FOR SYSTEMIC USE, PLAIN
H02 CORTICOSTEROIDS FOR SYSTEMIC USE
H Systemic hormonal preparations, excluding sex hormones and insulins
R01AD Corticosteroids
R01A DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01 NASAL PREPARATIONS
R Respiratory system
S01BA Corticosteroids, plain
S01B ANTIINFLAMMATORY AGENTS
S01 OPHTHALMOLOGICALS
S Sensory organs
S01CB Corticosteroids/antiinfectives/mydriatics in combination
S01C ANTIINFLAMMATORY AGENTS AND ANTIINFECTIVES IN COMBINATION
S01 OPHTHALMOLOGICALS
S Sensory organs
S02BA Corticosteroids
S02B CORTICOSTEROIDS
S02 OTOLOGICALS
S Sensory organs
S03BA Corticosteroids
S03B CORTICOSTEROIDS
S03 OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S Sensory organs

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
Epic Pharma Llc METHYLPREDNISOLONE ACETATE methylprednisolone acetate INJECTABLE;INJECTION 086903-002 Oct 20, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eugia Pharma METHYLPREDNISOLONE ACETATE methylprednisolone acetate INJECTABLE;INJECTION 211930-002 Apr 13, 2023 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Watson Labs METHYLPREDNISOLONE ACETATE methylprednisolone acetate INJECTABLE;INJECTION 086507-001 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

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