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Last Updated: May 27, 2022

DULERA Drug Patent Profile


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

Dulera is a drug marketed by Organon and is included in one NDA.

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

Summary for DULERA
Drug patent expirations by year for DULERA
Drug Prices for DULERA

See drug prices for DULERA

Drug Sales Revenue Trends for DULERA

See drug sales revenues for DULERA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for DULERA
Generic Entry Date for DULERA*:
Constraining patent/regulatory exclusivity:
NEW STRENGTH
NDA:
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

SponsorPhase
SanofiPhase 2
Regeneron PharmaceuticalsPhase 2
West Penn Allegheny Health SystemPhase 4

See all DULERA clinical trials

US Patents and Regulatory Information for DULERA

DULERA is protected by zero US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of DULERA is See Plans and Pricing.

This potential generic entry date is based on NEW STRENGTH.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

FDA Regulatory Exclusivity protecting DULERA

NEW STRENGTH
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Organon DULERA formoterol fumarate; mometasone furoate AEROSOL, METERED;INHALATION 022518-003 Aug 12, 2019 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Organon DULERA formoterol fumarate; mometasone furoate AEROSOL, METERED;INHALATION 022518-002 Jun 22, 2010 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Organon DULERA formoterol fumarate; mometasone furoate AEROSOL, METERED;INHALATION 022518-003 Aug 12, 2019 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Organon DULERA formoterol fumarate; mometasone furoate AEROSOL, METERED;INHALATION 022518-001 Jun 22, 2010 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 DULERA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon DULERA formoterol fumarate; mometasone furoate AEROSOL, METERED;INHALATION 022518-002 Jun 22, 2010 See Plans and Pricing See Plans and Pricing
Organon DULERA formoterol fumarate; mometasone furoate AEROSOL, METERED;INHALATION 022518-001 Jun 22, 2010 See Plans and Pricing See Plans and Pricing
Organon DULERA formoterol fumarate; mometasone furoate AEROSOL, METERED;INHALATION 022518-001 Jun 22, 2010 See Plans and Pricing See Plans and Pricing
Organon DULERA formoterol fumarate; mometasone furoate AEROSOL, METERED;INHALATION 022518-002 Jun 22, 2010 See Plans and Pricing See Plans and Pricing
Organon DULERA formoterol fumarate; mometasone furoate AEROSOL, METERED;INHALATION 022518-002 Jun 22, 2010 See Plans and Pricing See Plans and Pricing
Organon DULERA formoterol fumarate; mometasone furoate AEROSOL, METERED;INHALATION 022518-001 Jun 22, 2010 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for DULERA

See the table below for patents covering DULERA around the world.

Country Patent Number Title Estimated Expiration
Denmark 1174138 See Plans and Pricing
European Patent Office 1192946 See Plans and Pricing
Denmark 2156840 See Plans and Pricing
Japan 5247265 See Plans and Pricing
European Patent Office 1174139 Utilisation du furoate de mometasone pour le traitement des affections pulmonaires et des voies respiratoires (Use of mometasone furoate for treating airway passage and lung diseases) See Plans and Pricing
Germany 69526425 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DULERA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2435025 2019026 Norway See Plans and Pricing PRODUCT NAME: KOMBINASJON AV GLYKOPYRROLAT (INKLUDERT EVENTUELLE FARMASOEYTISK AKSEPTABLE SALTER, ESTERE ELLER ENANTIOMERER DERAV) OG FORMOTEROL (INNBEFATTENDE HVILKE SOM HELST FARMASOEYTISK AKSEPTABLE SALTER, ESTERE ELLER ENANTIOMERER DERAV); REG. NO/DATE: EU/1/18/1339 20190104
2435024 C202130025 Spain See Plans and Pricing PRODUCT NAME: UNA COMBINACION DE FORMOTEROL ( INCLUIDAS SUS SALES, ESTERES, SOLVATOS O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES I, GLICOPIRROLATO ( INCLUIDAS SUS SALES, ESTERES, SOLVATOS O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES ) Y BUDESONIDA ( INCLUIDAS SUS SALES, ESTERES, SOLVATOS O ENANTIOMEROS FARMACEUTICAMENTE ACEPTABLES ).; NATIONAL AUTHORISATION NUMBER: EU/1/20/1498; DATE OF AUTHORISATION: 20201209; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1498; DATE OF FIRST AUTHORISATION IN EEA: 20201209
2435024 15/2021 Austria See Plans and Pricing PRODUCT NAME: FORMOTEROLFUMARAT-DIHYDRAT / GLYCOPYRRONIUMBROMID / BUDESONID; REGISTRATION NO/DATE: EU/1/20/1498 (MITTEILUNG) 20201210
2435024 122021000026 Germany See Plans and Pricing PRODUCT NAME: GLYCOPYRROLAT MIT FORMOTEROL MIT BUDESONID, ODER SALZE, ESTER, SOLVATE, ENANTIOMERE UND MISCHUNGEN VON ENANTIOMEREN DERSELBEN; REGISTRATION NO/DATE: EU/1/20/1498 20201209
2435025 300995 Netherlands See Plans and Pricing PRODUCT NAME: COMBINATIE VAN GLYCOPYRRONIUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER, IN HET BIJZONDER GLYCOPYRRONIUYM BROMIDE, EN FORMOTEROL, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF ESTER, IN HET BIJZONDER FORMOTEROL FUMARAAT DIHYDRAAT; REGISTRATION NO/DATE: EU/ 1/18/1339 20181220
2435025 36/2019 Austria See Plans and Pricing PRODUCT NAME: GLYCOPYRRONIUMBROMID / FORMOTEROL; REGISTRATION NO/DATE: EU/1/18/1339 (MITTEILUNG) 20181220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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