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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

Dulera was eligible for patent challenges on December 31^st, 1968.

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

Annual sales in 2017 were $777mm indicating the motivation for generic entry (peak sales were $1.1bn in 2016).

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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:

INFORMATION ADDED TO THE CLINICAL TRIALS SECTION OF THE LABELING REGARDING A POSTMARKETING SAFETY AND EFFICACY STUDY EVALUATING THE RISK OF SERIOUS ASTHMA-RELATED EVENTS

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

Recent Litigation for DULERA

Identify potential future generic entrants

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 DULERA litigation

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

International Patents for DULERA

Country	Patent Number	Estimated Expiration
United Kingdom	9904919
Japan	2013067668
Germany	60003160
Hungary	229073

Supplementary Protection Certificates for DULERA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	CA 2019 00032	Denmark		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
2435025	PA2019014	Lithuania		PRODUCT NAME: GLIKOPIROLATO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, ENANTIOMERUS AR KITUS DARINIUS) IR FORMOTEROLIO (ISKAITANT BET KOKIAS JO FARMACINIU POZIURIU PRIIMTINAS DRUSKAS, ESTERIUS, ENANTIOMERUS AR KITUS DARINIUS) DERINYS; REGISTRATION NO/DATE: EU/1/18/1339 20181218
0613371	2002C/022	Belgium		PRODUCT NAME: BUDESONID. MICRONIS. AND FORMOTEROL. FUMARAS DIHYDR., NATL REGISTRATION NO/DATE: 624 IS 234 F 0 20010129; FIRST REGISTRATION: SE 16047 20000825