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Formoterol fumarate; mometasone furoate - Generic Drug Details
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What are the generic drug sources for formoterol fumarate; mometasone furoate and what is the scope of freedom to operate?
Formoterol fumarate; mometasone furoate
is the generic ingredient in one branded drug marketed by Merck Sharp Dohme and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Formoterol fumarate; mometasone furoate has thirty-seven patent family members in twenty-six countries.
There are nineteen drug master file entries for formoterol fumarate; mometasone furoate. Two suppliers are listed for this compound.
Summary for formoterol fumarate; mometasone furoate
International Patents: | 37 |
US Patents: | 2 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 19 |
Suppliers / Packagers: | 2 |
Clinical Trials: | 15 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for formoterol fumarate; mometasone furoate |
DailyMed Link: | formoterol fumarate; mometasone furoate at DailyMed |
Recent Clinical Trials for formoterol fumarate; mometasone furoate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Merck Sharp & Dohme Corp. | Phase 4 |
Schering-Plough | Phase 2 |
Novartis | Phase 2 |
See all formoterol fumarate; mometasone furoate clinical trials
Recent Litigation for formoterol fumarate; mometasone furoate
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 |
Pharmacology for formoterol fumarate; mometasone furoate
Drug Class | Corticosteroid beta2-Adrenergic Agonist |
Mechanism of Action | Corticosteroid Hormone Receptor Agonists Adrenergic beta2-Agonists |
US Patents and Regulatory Information for formoterol fumarate; mometasone furoate
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 | 022518-001 | 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 formoterol fumarate; mometasone furoate
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 | 022518-002 | 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 | 022518-002 | Jun 22, 2010 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for formoterol fumarate; mometasone furoate
Country | Patent Number | Estimated Expiration |
---|---|---|
Hong Kong | 1043048 | Start Trial |
Poland | 212355 | Start Trial |
Japan | 5663046 | Start Trial |
European Patent Office | 1325765 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for formoterol fumarate; mometasone furoate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 | CA 2019 00032 | Denmark | Start Trial | 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 | 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 |
2435025 | 300995 | Netherlands | Start Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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