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Last Updated: December 4, 2024

Methylprednisolone sodium succinate - Generic Drug Details


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

Methylprednisolone sodium succinate is the generic ingredient in four branded drugs marketed by Abbott, Hospira, Hospira Inc, Elkins Sinn, Organon Usa Inc, Abraxis Pharm, Amneal, Bedford Labs, Eugia Pharma, Fresenius Kabi Usa, Hikma, Intl Medication, Sagent Pharms Inc, Teva Parenteral, Tianjin Kingyork, Watson Labs, and Pharmacia And Upjohn, and is included in forty-nine NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for methylprednisolone sodium succinate. Fourteen suppliers are listed for this compound.

Summary for methylprednisolone sodium succinate
US Patents:0
Tradenames:4
Applicants:17
NDAs:49
Drug Master File Entries: 2
Finished Product Suppliers / Packagers: 14
Raw Ingredient (Bulk) Api Vendors: 39
Clinical Trials: 34
Patent Applications: 6,657
What excipients (inactive ingredients) are in methylprednisolone sodium succinate?methylprednisolone sodium succinate excipients list
DailyMed Link:methylprednisolone sodium succinate at DailyMed
Recent Clinical Trials for methylprednisolone sodium succinate

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

SponsorPhase
Leiden University Medical CenterPhase 3
Maastricht University Medical CenterPhase 3
Gelre HospitalsPhase 3

See all methylprednisolone sodium succinate clinical trials

Pharmacology for methylprednisolone sodium succinate
Anatomical Therapeutic Chemical (ATC) Classes for methylprednisolone sodium succinate
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 sodium succinate

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 SODIUM SUCCINATE methylprednisolone sodium succinate INJECTABLE;INJECTION 040888-005 Jul 18, 2011 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Bedford Labs METHYLPREDNISOLONE SODIUM SUCCINATE methylprednisolone sodium succinate INJECTABLE;INJECTION 040641-002 Feb 21, 2007 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Eugia Pharma METHYLPREDNISOLONE SODIUM SUCCINATE methylprednisolone sodium succinate INJECTABLE;INJECTION 207667-003 Dec 15, 2015 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma METHYLPREDNISOLONE SODIUM SUCCINATE methylprednisolone sodium succinate INJECTABLE;INJECTION 203125-001 Sep 26, 2022 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pharmacia And Upjohn SOLU-MEDROL methylprednisolone sodium succinate INJECTABLE;INJECTION 011856-006 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  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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