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DULERA Drug Profile

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When do Dulera patents expire, and what generic alternatives are available?

Dulera is a drug marketed by Merck Sharp Dohme and is included in one NDA. There are two patents protecting this drug.

This drug has thirty-seven patent family members in twenty-six countries.

The generic ingredient in DULERA is formoterol fumarate; mometasone furoate. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the formoterol fumarate; mometasone furoate profile page.

US ANDA Litigation and Generic Entry Outlook for Dulera

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 20, 2020. This may change due to patent challenges or generic licensing.

Annual sales in 2018 were $867mm indicating the motivation for generic entry (peak sales were $1.1bn in 2016).

Indicators of Generic Entry

Summary for DULERA

International Patents:	37
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Clinical Trials:	4
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for DULERA
Drug Sales Revenues:	Drug sales revenues for DULERA
DailyMed Link:	DULERA at DailyMed

See drug prices for DULERA

See drug sales revenues for DULERA

Generic Entry Opportunity Date for DULERA

Constraining patent/regulatory exclusivity:

NDA:

022518

Dosage:

AEROSOL, METERED;INHALATION

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for DULERA

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

Sponsor	Phase
Sanofi	Phase 2
Regeneron Pharmaceuticals	Phase 2
West Penn Allegheny Health System	Phase 4

See all DULERA clinical trials

Pharmacology for DULERA

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

US Patents and Regulatory Information for DULERA

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	022518-003	Aug 12, 2019		RX	Yes	No
Merck Sharp Dohme	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-002	Jun 22, 2010		RX	Yes	Yes					Y
Merck Sharp Dohme	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-001	Jun 22, 2010		RX	Yes	Yes
Merck Sharp Dohme	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-002	Jun 22, 2010		RX	Yes	Yes

Expired US Patents for DULERA

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
Merck Sharp Dohme	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-002	Jun 22, 2010
Merck Sharp Dohme	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-001	Jun 22, 2010
Merck Sharp Dohme	DULERA	formoterol fumarate; mometasone furoate	AEROSOL, METERED;INHALATION	022518-002	Jun 22, 2010

International Patents for DULERA

Country	Patent Number	Estimated Expiration
New Zealand	279979
European Patent Office	1192946
Japan	2012036222
China	101164542

Supplementary Protection Certificates for DULERA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2435025	19C1040	France		PRODUCT NAME: COMBINAISON DE GLYCOPYRROLATE (Y COMPRIS TOUS SELS, ESTERS, ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI) ET DE FORMOTEROL (Y COMPRIS TOUS SELS, ESTERS, ENANTIOMERES PHARMACEUTIQUEMENT ACCEPTABLES DE CELUI-CI); NAT. REGISTRATION NO/DATE: EU/1/18/1339 20181220; FIRST REGISTRATION: - EU/1/18/1339 20181220
0613371	SPC/GB02/033	United Kingdom		PRODUCT NAME: FORMOTEROL (OPTIONALLY IN THE FORM OF THE FREE BASE OR A PHYSIOLOGICALLY ACCEPTABLE SALT THEREOF, OR A SOLVATE OF SUCH FREE BASE OR SALT ESPECIALLY AS FORMOTEROL FUMARATE DIHYDRATE) AND BUDESONIDE; REGISTERED: SE SE16047, 16048 20000825; UK PL17901/0091 20010515; UK PL17901/0092 20010515
2435025	C201930043	Spain		PRODUCT NAME: UNA COMBINACION DE GLICOPIRROLATO (INCLUYENDO CUALQUIERA DE SUS SALES, ESTERES O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES) Y FORMOTEROL (INCLUYENDO CUALQUIERA DE SUS SALES, ESTERES O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES).; NATIONAL AUTHORISATION NUMBER: EU/1/18/1339; DATE OF AUTHORISATION: 20181218; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1339; DATE OF FIRST AUTHORISATION IN EEA: 20181218
2435025	LUC00124	Luxembourg		PRODUCT NAME: UNE COMBINAISON DE GLYCOPYRROLATE (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES) ET DE FORMOTEROL (Y COMPRIS SES SELS, ESTERS, ENANTIOMERES OU AUTRES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES); AUTHORISATION NUMBER AND DATE: EU/1/18/1339 20181220