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Last Updated: June 19, 2021

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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 freedom to operate?

Methylprednisolone acetate is the generic ingredient in six branded drugs marketed by Pharmacia And Upjohn, Pfizer, 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
Fayoum University HospitalPhase 4
Tel-Aviv Sourasky Medical CenterN/A
Mercy Health OhioN/A

See all methylprednisolone acetate clinical trials

Pharmacology for methylprednisolone acetate
ATC Classes for methylprednisolone acetate
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
Sandoz Inc METHYLPREDNISOLONE ACETATE methylprednisolone acetate INJECTABLE;INJECTION 040794-001 Mar 5, 2009 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Watson Labs METHYLPREDNISOLONE ACETATE methylprednisolone acetate INJECTABLE;INJECTION 086507-001 Approved Prior to Jan 1, 1982 DISCN No No   Get Started Free   Get Started Free   Get Started Free
Sandoz Inc METHYLPREDNISOLONE ACETATE methylprednisolone acetate INJECTABLE;INJECTION 040719-002 Jan 29, 2009 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Watson Labs METHYLPREDNISOLONE ACETATE methylprednisolone acetate INJECTABLE;INJECTION 085374-001 Approved Prior to Jan 1, 1982 DISCN No No   Get Started Free   Get Started Free   Get Started Free
Teva Pharms Usa METHYLPREDNISOLONE ACETATE methylprednisolone acetate INJECTABLE;INJECTION 040557-002 Feb 23, 2005 AB RX No No   Get Started Free   Get Started Free   Get Started Free
Teva Pharms Usa METHYLPREDNISOLONE ACETATE methylprednisolone acetate INJECTABLE;INJECTION 040620-002 Oct 27, 2006 AB RX No No   Get Started Free   Get Started Free   Get Started Free
>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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