Formoterol fumarate; mometasone furoate - Generic Drug Details

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What are the generic drug sources for formoterol fumarate; mometasone furoate and what is the scope of patent protection?

Formoterol fumarate; mometasone furoate is the generic ingredient in one branded drug marketed by Organon Llc and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for formoterol fumarate; mometasone furoate

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	15
DailyMed Link:	formoterol fumarate; mometasone furoate at DailyMed

Recent Clinical Trials for formoterol fumarate; mometasone furoate

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

Sponsor	Phase
Merck Sharp & Dohme Corp.	Phase 4
Schering-Plough	Phase 2
Novartis	Phase 2

See all formoterol fumarate; mometasone furoate clinical trials

Pharmacology for formoterol fumarate; mometasone furoate

Drug Class	Corticosteroid beta2-Adrenergic Agonist
Mechanism of Action	Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for formoterol fumarate; mometasone furoate

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

R01AD	Corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03AC	Selective beta-2-adrenoreceptor agonists
R03A	ADRENERGICS, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

R03BA	Glucocorticoids
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

R03CC	Selective beta-2-adrenoreceptor agonists
R03C	ADRENERGICS FOR SYSTEMIC USE
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

US Patents and Regulatory Information for formoterol fumarate; mometasone furoate

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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
Organon Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-001	Jun 22, 2010		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Organon Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-002	Jun 22, 2010		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Organon Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-003	Aug 12, 2019		RX	Yes	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 formoterol fumarate; mometasone furoate

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-001	Jun 22, 2010	⤷ Sign Up	⤷ Sign Up
Organon Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-001	Jun 22, 2010	⤷ Sign Up	⤷ Sign Up
Organon Llc	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-002	Jun 22, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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