HYDROCORTISONE SODIUM SUCCINATE - Generic Drug Details

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

Hydrocortisone sodium succinate is the generic ingredient in three branded drugs marketed by Abbott, Hospira, Abraxis Pharm, Apotex, Baxter Hlthcare, Cipla, Intl Medication, Watson Labs, Zydus Pharms, and Pharmacia And Upjohn, and is included in twenty-eight NDAs. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for hydrocortisone sodium succinate. Eight suppliers are listed for this compound.

Summary for HYDROCORTISONE SODIUM SUCCINATE

US Patents:	0
Tradenames:	3
Applicants:	10
NDAs:	28
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	29
Patent Applications:	2,720
What excipients (inactive ingredients) are in HYDROCORTISONE SODIUM SUCCINATE?	HYDROCORTISONE SODIUM SUCCINATE excipients list
DailyMed Link:	HYDROCORTISONE SODIUM SUCCINATE at DailyMed

Recent Clinical Trials for HYDROCORTISONE SODIUM SUCCINATE

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

Sponsor	Phase
Second Affiliated Hospital of Wenzhou Medical University	PHASE1
National Cancer Institute (NCI)	PHASE1
Geron Corporation	PHASE1

See all HYDROCORTISONE SODIUM SUCCINATE clinical trials

Pharmacology for HYDROCORTISONE SODIUM SUCCINATE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for HYDROCORTISONE 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

D07XA	Corticosteroids, weak, other combinations
D07X	CORTICOSTEROIDS, OTHER COMBINATIONS
D07	CORTICOSTEROIDS, DERMATOLOGICAL 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

S01BA	Corticosteroids, plain
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

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

US Patents and Regulatory Information for HYDROCORTISONE SODIUM SUCCINATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pharmacia And Upjohn	SOLU-CORTEF	hydrocortisone sodium succinate	INJECTABLE;INJECTION	009866-002	Approved Prior to Jan 1, 1982		RX	Yes	Yes
Watson Labs	HYDROCORTISONE SODIUM SUCCINATE	hydrocortisone sodium succinate	INJECTABLE;INJECTION	084737-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Intl Medication	HYDROCORTISONE SODIUM SUCCINATE	hydrocortisone sodium succinate	INJECTABLE;INJECTION	087532-001	Mar 19, 1982		DISCN	No	No
Baxter Hlthcare	HYDROCORTISONE SODIUM SUCCINATE	hydrocortisone sodium succinate	INJECTABLE;INJECTION	086619-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Baxter Hlthcare	HYDROCORTISONE SODIUM SUCCINATE	hydrocortisone sodium succinate	INJECTABLE;INJECTION	087569-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Hospira	A-HYDROCORT	hydrocortisone sodium succinate	INJECTABLE;INJECTION	085930-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Baxter Hlthcare	HYDROCORTISONE SODIUM SUCCINATE	hydrocortisone sodium succinate	INJECTABLE;INJECTION	087567-001	Approved Prior to Jan 1, 1982		DISCN	No	No