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 Merck Sharp Dohme and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Formoterol fumarate; mometasone furoate has thirty-seven patent family members in twenty-six countries.

There are nineteen drug master file entries for formoterol fumarate; mometasone furoate. One supplier is listed for this compound.

Summary for formoterol fumarate; mometasone furoate

International Patents:	37
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	19
Suppliers / Packagers:	1
Clinical Trials:	15
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for formoterol fumarate; mometasone furoate
DailyMed Link:	formoterol fumarate; mometasone furoate at DailyMed

Recent Clinical Trials for formoterol fumarate; mometasone furoate

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

See all formoterol fumarate; mometasone furoate clinical trials

Recent Litigation for formoterol fumarate; mometasone furoate

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District Court Litigation

Case Name	Date
Meda Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc.	2015-09-08
MERCK SHARP & DOHME CORP. v. APOTEX INC.	2009-12-18

See all formoterol fumarate; mometasone furoate litigation

Pharmacology for formoterol fumarate; mometasone furoate

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

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
Merck Sharp Dohme	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-002	Jun 22, 2010		RX	Yes	Yes	Start Trial	Start Trial			Y	Start Trial
Merck Sharp Dohme	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-002	Jun 22, 2010		RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Merck Sharp Dohme	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-002	Jun 22, 2010		RX	Yes	Yes	Start Trial	Start Trial				Start Trial
Merck Sharp Dohme	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-001	Jun 22, 2010		RX	Yes	Yes	Start Trial	Start Trial			Y	Start Trial
Merck Sharp Dohme	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-002	Jun 22, 2010		RX	Yes	Yes	Start Trial	Start Trial			Y	Start Trial
>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
Merck Sharp Dohme	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-001	Jun 22, 2010	Start Trial	Start Trial
Merck Sharp Dohme	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-001	Jun 22, 2010	Start Trial	Start Trial
Merck Sharp Dohme	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-002	Jun 22, 2010	Start Trial	Start Trial
Merck Sharp Dohme	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-002	Jun 22, 2010	Start Trial	Start Trial
Merck Sharp Dohme	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-001	Jun 22, 2010	Start Trial	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for formoterol fumarate; mometasone furoate

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Country	Patent Number	Estimated Expiration
Germany	60003160	Start Trial
Portugal	1156790	Start Trial
Hungary	229073	Start Trial
New Zealand	513742	Start Trial
Norway	20013988	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for formoterol fumarate; mometasone furoate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435025	2019C/532	Belgium	Start Trial	PRODUCT NAME: UNE COMBINAISON DE GLYCOPYRROLATE (INCLUANT LES SELS ACCEPTABLES PHARMACEUTIQUEMENT, LES ESTERS, LES ENANTIOMERES OU LES AUTRES DERIVES DE CECI) ET DE FORMOTEROL (INCLUANT LES SELS ACCEPTABLES PHARMACEUTIQUEMENT, LES ESTERS, LES ENANTIOMERES OU LES AUTRES DERIVES DE CECI); AUTHORISATION NUMBER AND DATE: EU/1/18/1339 20181220
2435025	36/2019	Austria	Start Trial	PRODUCT NAME: GLYCOPYRRONIUMBROMID / FORMOTEROL; REGISTRATION NO/DATE: EU/1/18/1339 (MITTEILUNG) 20181220
2435025	CA 2019 00032	Denmark	Start Trial	PRODUCT NAME: KOMBINATION AF GLYCOPYRROLAT, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERER ELLER ANDRE DERIVATER DERAF, OG FORMOTEROL, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, ENANTIOMERER ELLER ANDRE DERIVATER DERAF; REG. NO/DATE: EU/1/18/1339 20181220
0613371	2002C/022	Belgium	Start Trial	PRODUCT NAME: BUDESONID. MICRONIS. AND FORMOTEROL. FUMARAS DIHYDR., NATL REGISTRATION NO/DATE: 624 IS 234 F 0 20010129; FIRST REGISTRATION: SE 16047 20000825
2435025	132019000000087	Italy	Start Trial	PRODUCT NAME: UNA COMBINAZIONE DI GLICOPIRROLATO (INCLUSI SUOI SALI, ESTERI, ENANTIOMERI O ALTRI DERIVATI FARMACEUTICAMENTE ACCETTABILI) E FORMOTEROLO (INCLUSI SUOI SALI, ESTERI, ENANTIOMERI O ALTRI DERIVATI FARMACEUTICAMENTE ACCETTABILI)(BEVESPI AEROSPHERE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1339, 20181220
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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