METHYLPREDNISOLONE SODIUM SUCCINATE - Generic Drug Details

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:	6,333
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

Sponsor	Phase
Gelre Hospitals	Phase 3
ZonMw: The Netherlands Organisation for Health Research and Development	Phase 3
Maasstad Hospital	Phase 3

See all METHYLPREDNISOLONE SODIUM SUCCINATE clinical trials

Pharmacology for METHYLPREDNISOLONE SODIUM SUCCINATE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

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
Hospira	A-METHAPRED	methylprednisolone sodium succinate	INJECTABLE;INJECTION	085855-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Fresenius Kabi Usa	METHYLPREDNISOLONE SODIUM SUCCINATE	methylprednisolone sodium succinate	INJECTABLE;INJECTION	040612-001	Aug 12, 2004	AP	RX	No	No
Eugia Pharma	METHYLPREDNISOLONE SODIUM SUCCINATE	methylprednisolone sodium succinate	INJECTABLE;INJECTION	207667-003	Dec 15, 2015		DISCN	No	No
Sagent Pharms Inc	METHYLPREDNISOLONE SODIUM SUCCINATE	methylprednisolone sodium succinate	INJECTABLE;INJECTION	040888-004	Jul 18, 2011	AP	RX	No	No
Hospira	A-METHAPRED	methylprednisolone sodium succinate	INJECTABLE;INJECTION	040665-001	Dec 20, 2005		DISCN	No	No
Hikma	METHYLPREDNISOLONE SODIUM SUCCINATE	methylprednisolone sodium succinate	INJECTABLE;INJECTION	203125-002	Sep 26, 2022	AP	RX	No	No
Tianjin Kingyork	METHYLPREDNISOLONE SODIUM SUCCINATE	methylprednisolone sodium succinate	INJECTABLE;INJECTION	212396-003	Apr 20, 2021	AP	RX	No	No