DULERA Drug Patent Profile
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When do Dulera patents expire, and when can generic versions of Dulera launch?
Dulera is a drug marketed by Organon Llc 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. One supplier is listed for this compound. Additional details are available on the formoterol fumarate; mometasone furoate profile page.
Summary for DULERA
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product 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 |
What excipients (inactive ingredients) are in DULERA? | DULERA excipients list |
DailyMed Link: | DULERA at DailyMed |
Recent Clinical Trials for DULERA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Sanofi | Phase 2 |
Regeneron Pharmaceuticals | Phase 2 |
Asthma Management Systems | Phase 4 |
Pharmacology for DULERA
Drug Class | Corticosteroid beta2-Adrenergic Agonist |
Mechanism of Action | Adrenergic beta2-Agonists Corticosteroid Hormone Receptor Agonists |
Anatomical Therapeutic Chemical (ATC) Classes for DULERA
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Organon Llc | DULERA | formoterol fumarate; mometasone furoate | AEROSOL, METERED;INHALATION | 022518-003 | Aug 12, 2019 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Organon Llc | DULERA | formoterol fumarate; mometasone furoate | AEROSOL, METERED;INHALATION | 022518-001 | Jun 22, 2010 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Organon Llc | DULERA | formoterol fumarate; mometasone furoate | AEROSOL, METERED;INHALATION | 022518-002 | Jun 22, 2010 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 |
---|---|---|---|---|---|---|---|
Organon Llc | DULERA | formoterol fumarate; mometasone furoate | AEROSOL, METERED;INHALATION | 022518-001 | Jun 22, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon Llc | DULERA | formoterol fumarate; mometasone furoate | AEROSOL, METERED;INHALATION | 022518-002 | Jun 22, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon Llc | DULERA | formoterol fumarate; mometasone furoate | AEROSOL, METERED;INHALATION | 022518-001 | Jun 22, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon Llc | DULERA | formoterol fumarate; mometasone furoate | AEROSOL, METERED;INHALATION | 022518-002 | Jun 22, 2010 | ⤷ Try a Trial | ⤷ Try a Trial |
>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 |
---|---|---|---|
Israel | 112459 | Use of mometasone furoate in the manufacture of a medicament for treating airway passage and lung diseases | ⤷ Try a Trial |
Cyprus | 2616 | Use of mometasone furoate for treating airway passage and lung diseases | ⤷ Try a Trial |
Japan | 2002538110 | ⤷ Try a Trial | |
Japan | H09501700 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for DULERA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2435024 | 301102 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: COMBINATIE VAN FORMOTEROL (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN), GLYCOPYRROLAAT (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN) EN BUDESONIDE (MET INBEGRIP VAN DE FARMACEUTISCH AANVAARDBARE ZOUTEN, ESTERS, SOLVATEN OF ENANTIOMEREN ERVAN); REGISTRATION NO/DATE: EU/1/20/1498 20201210 |
2435025 | PA2019014,C2435025 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: GLIKOPIRONIO BROMIDAS/FORMOTEROLIS; REGISTRATION NO/DATE: EU/1/18/1339 20181218 |
2435024 | 2190014-7 | Sweden | ⤷ Try a Trial | PRODUCT NAME: A COMBINATION OF FORMOTEROL INCLUDING ANY PHARMACEUUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, GLYCOPYRROLATE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALTS, ESTERS, OR SOLVATES THEREOF, AND BUDESONIDE INCLUDING ANY PHARMACEUTICALLY ACCEPTABLE SALT, ESTERS ORSOLVATES THEREOF; REG. NO/DATE: EU/1/20/1498 20201210 |
2435024 | CR 2021 00014 | Denmark | ⤷ Try a Trial | PRODUCT NAME: KOMBINATION AF FORMOTEROL, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, SOLVATER ELLER ENANTIOMERE DERAF, GLYCOPYRROLAT, HERUNDER ALLE FARMACEUTISK ACCEPTABLE SALTE, ESTERE, SOLVATER ELLER ENANTIOMERE DERAF, OG BUDESONID, HERUNDER...; REG. NO/DATE: EU/1/20/1498 20201210 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |