BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE - Generic Drug Details

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What are the generic drug sources for betamethasone dipropionate; clotrimazole and what is the scope of patent protection?

Betamethasone dipropionate; clotrimazole is the generic ingredient in two branded drugs marketed by Actavis Mid Atlantic, Fougera Pharms, Glenmark Speclt, Taro, Organon, and Merck Sharp Dohme, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

Seventeen suppliers are listed for this compound.

Summary for BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	8
Finished Product Suppliers / Packagers:	17
Clinical Trials:	1
DailyMed Link:	BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE at DailyMed

Recent Clinical Trials for BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE

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

Sponsor	Phase
Ache Laboratorios Farmaceuticos S.A.	Phase 3

See all BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE clinical trials

Pharmacology for BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE

Drug Class	Azole Antifungal Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE

A01AB	Antiinfectives and antiseptics 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

D01AC	Imidazole and triazole derivatives
D01A	ANTIFUNGALS FOR TOPICAL USE
D01	ANTIFUNGALS FOR DERMATOLOGICAL USE
D	Dermatologicals

D07AC	Corticosteroids, potent (group III)
D07A	CORTICOSTEROIDS, PLAIN
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

D07XC	Corticosteroids, potent, other combinations
D07X	CORTICOSTEROIDS, OTHER COMBINATIONS
D07	CORTICOSTEROIDS, DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

G01AF	Imidazole derivatives
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

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

R03BA	Glucocorticoids
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
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 BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fougera Pharms	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	betamethasone dipropionate; clotrimazole	LOTION;TOPICAL	076516-001	Jun 16, 2005	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Merck Sharp Dohme	LOTRISONE	betamethasone dipropionate; clotrimazole	LOTION;TOPICAL	020010-001	Dec 8, 2000		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fougera Pharms	CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE	betamethasone dipropionate; clotrimazole	CREAM;TOPICAL	075502-001	Jun 5, 2001	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	LOTRISONE	betamethasone dipropionate; clotrimazole	CREAM;TOPICAL	018827-001	Jul 10, 1984	⤷ Sign Up	⤷ Sign Up
Organon	LOTRISONE	betamethasone dipropionate; clotrimazole	CREAM;TOPICAL	018827-001	Jul 10, 1984	⤷ Sign Up	⤷ Sign Up
Organon	LOTRISONE	betamethasone dipropionate; clotrimazole	CREAM;TOPICAL	018827-001	Jul 10, 1984	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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