Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 17, 2019

DrugPatentWatch Database Preview

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. Two suppliers are listed for this compound. Additional details are available on the formoterol fumarate; mometasone furoate profile page.

Drug patent expirations by year for DULERA
Drug Prices for DULERA

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Drug Sales Revenue Trends for DULERA

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Generic Entry Opportunity Date for DULERA
Generic Entry Date for DULERA*:
Constraining patent/regulatory exclusivity:
PEDIATRIC EXCLUSIVITY
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
Asthma Management SystemsPhase 4

See all DULERA clinical trials

Recent Litigation for DULERA

Identify potential future generic entrants

District Court Litigation
Case NameDate
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

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   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 Y   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   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
>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
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
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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for DULERA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2435025 122019000068 Germany   Start Trial PRODUCT NAME: KOMBINATION VON GLYCOPYRROLAT, EINSCHLIESSLICH BELIEBIGER PHARMAZEUTISCH VERTRAEGLICHER SALZE, ESTER, ENANTIOMERE, ODER ANDERER DERIVATE DAVON, UND FORMOTEROL, EINSCHLIESSLICH BELIEBIGER PHARMAZEUTISCH VERTRAEGLICHER SALZE, ESTER, ENANTIOMERE, ODER ANDERER DERIVATE DAVON; REGISTRATION NO/DATE: EU/1/18/1339 20181218
0613371 SPC/GB02/033 United Kingdom   Start Trial 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 PA2019014 Lithuania   Start Trial 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
2435025 300995 Netherlands   Start Trial PRODUCT NAME: EEN COMBINATIE VAN GLYCOPYRROLAAT (MET INBEGRIP VAN ALLE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, ENANTIOMEREN OF ANDERE DERIVATEN DAARVAN) EN FORMOTEROL (MET INBEGRIP VAN ALLE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, ENANTIOMEREN OF ANDERE DERIVATEN DAARVAN); REGISTRATION 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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