HYDROCORTISONE SODIUM SUCCINATE Drug Patent Profile

Which patents cover Hydrocortisone Sodium Succinate, and what generic alternatives are available?

Hydrocortisone Sodium Succinate is a drug marketed by Abraxis Pharm, Apotex, Baxter Hlthcare, Cipla, Intl Medication, Watson Labs, and Zydus Pharms. and is included in seventeen NDAs.

The generic ingredient in HYDROCORTISONE SODIUM SUCCINATE is hydrocortisone sodium succinate. There are sixty-seven drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the hydrocortisone sodium succinate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Hydrocortisone Sodium Succinate

A generic version of HYDROCORTISONE SODIUM SUCCINATE was approved as hydrocortisone sodium succinate by CIPLA on September 5^th, 2024.

Summary for HYDROCORTISONE SODIUM SUCCINATE

US Patents:	0
Applicants:	7
NDAs:	17
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	29
Patent Applications:	1,797
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
Children's Oncology Group	PHASE1
National Cancer Institute (NCI)	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
Abraxis Pharm	HYDROCORTISONE SODIUM SUCCINATE	hydrocortisone sodium succinate	INJECTABLE;INJECTION	088670-001	Jun 8, 1984		DISCN	No	No
Zydus Pharms	HYDROCORTISONE SODIUM SUCCINATE	hydrocortisone sodium succinate	INJECTABLE;INJECTION	217191-001	May 7, 2026	AP	RX	No	No
Baxter Hlthcare	HYDROCORTISONE SODIUM SUCCINATE	hydrocortisone sodium succinate	INJECTABLE;INJECTION	087569-001	Approved Prior to Jan 1, 1982		DISCN	No	No