METHYLPREDNISOLONE ACETATE - Generic Drug Details

What are the generic drug sources for methylprednisolone acetate and what is the scope of patent protection?

Methylprednisolone acetate is the generic ingredient in six branded drugs marketed by Pharmacia And Upjohn, Pfizer, Bel Mar, Amneal, Endo Operations, Epic Pharma Llc, Eugia Pharma, Hong Kong, Sagent Pharms Inc, Sandoz, Teva Pharms Usa, Watson Labs, and Wilshire Pharms Inc, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for methylprednisolone acetate. Twelve suppliers are listed for this compound.

Summary for METHYLPREDNISOLONE ACETATE

US Patents:	0
Tradenames:	6
Applicants:	13
NDAs:	23
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	38
Patent Applications:	6,855
Drug Prices:	Drug price trends for METHYLPREDNISOLONE ACETATE
What excipients (inactive ingredients) are in METHYLPREDNISOLONE ACETATE?	METHYLPREDNISOLONE ACETATE excipients list
DailyMed Link:	METHYLPREDNISOLONE ACETATE at DailyMed

See drug prices for METHYLPREDNISOLONE ACETATE

See drug sales revenues for METHYLPREDNISOLONE ACETATE

Recent Clinical Trials for METHYLPREDNISOLONE ACETATE

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

Sponsor	Phase
Menoufia University	N/A
Centre hospitalier de l'Université de Montréal (CHUM)	Phase 4
Yale University	Phase 2

See all METHYLPREDNISOLONE ACETATE clinical trials

Pharmacology for METHYLPREDNISOLONE ACETATE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for METHYLPREDNISOLONE ACETATE

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 ACETATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal	METHYLPREDNISOLONE ACETATE	methylprednisolone acetate	INJECTABLE;INJECTION	216502-002	Nov 3, 2023	AB	RX	No	No
Amneal	METHYLPREDNISOLONE ACETATE	methylprednisolone acetate	INJECTABLE;INJECTION	210043-002	May 20, 2019	AB	RX	No	Yes
Bel Mar	M-PREDROL	methylprednisolone acetate	INJECTABLE;INJECTION	087135-001	Approved Prior to Jan 1, 1982		DISCN	No	No