FLUOROMETHOLONE - Generic Drug Details

What are the generic sources for fluorometholone and what is the scope of freedom to operate?

Fluorometholone is the generic ingredient in eight branded drugs marketed by Pharmacia And Upjohn, Allergan, Novartis, Amneal, Abbvie, and Harrow Eye, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for fluorometholone. Three suppliers are listed for this compound.

Summary for FLUOROMETHOLONE

US Patents:	0
Tradenames:	8
Applicants:	6
NDAs:	9
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	22
Patent Applications:	6,752
Drug Prices:	Drug price trends for FLUOROMETHOLONE
What excipients (inactive ingredients) are in FLUOROMETHOLONE?	FLUOROMETHOLONE excipients list
DailyMed Link:	FLUOROMETHOLONE at DailyMed

See drug prices for FLUOROMETHOLONE

Recent Clinical Trials for FLUOROMETHOLONE

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

Sponsor	Phase
Maastricht University Medical Center	Phase 4
Navy Medical Center San Diego	Phase 4
Benha University	Phase 1

See all FLUOROMETHOLONE clinical trials

Pharmacology for FLUOROMETHOLONE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Medical Subject Heading (MeSH) Categories for FLUOROMETHOLONE

Anti-Allergic Agents

Anti-Inflammatory Agents

Glucocorticoids

Anatomical Therapeutic Chemical (ATC) Classes for FLUOROMETHOLONE

C05AA	Corticosteroids
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

D07AB	Corticosteroids, moderately potent (group II)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

D07XB	Corticosteroids, moderately potent, 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

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

US Patents and Regulatory Information for FLUOROMETHOLONE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal	FLUOROMETHOLONE	fluorometholone	SUSPENSION/DROPS;OPHTHALMIC	216348-001	Jan 9, 2024	AB	RX	No	No
Allergan	FML-S	fluorometholone; sulfacetamide sodium	SUSPENSION/DROPS;OPHTHALMIC	019525-001	Sep 29, 1989		DISCN	No	No
Abbvie	FML FORTE	fluorometholone	SUSPENSION/DROPS;OPHTHALMIC	019216-001	Apr 23, 1986		RX	Yes	Yes
Allergan	FML	fluorometholone	OINTMENT;OPHTHALMIC	017760-001	Sep 4, 1985		DISCN	Yes	No
Novartis	FLUOR-OP	fluorometholone	SUSPENSION/DROPS;OPHTHALMIC	070185-001	Feb 27, 1986		DISCN	No	No
Pharmacia And Upjohn	OXYLONE	fluorometholone	CREAM;TOPICAL	011748-001	Approved Prior to Jan 1, 1982		DISCN	No	No