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Mometasone furoate - Generic Drug Details
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What are the generic sources for mometasone furoate and what is the scope of patent protection?
Mometasone furoate
is the generic ingredient in six branded drugs marketed by Merck Sharp Dohme, Anda Repository, Cosette, Fougera Pharms, Glenmark Generics, Taro, Intersect Ent Inc, Perrigo Israel, Perrigo New York, Torrent, Amneal Pharms, and Apotex Inc, and is included in twenty-seven NDAs. There are thirteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Mometasone furoate has forty-seven patent family members in twelve countries.
There are thirty drug master file entries for mometasone furoate. Eighteen suppliers are listed for this compound.
Summary for mometasone furoate
International Patents: | 47 |
US Patents: | 13 |
Tradenames: | 6 |
Applicants: | 12 |
NDAs: | 27 |
Drug Master File Entries: | 30 |
Suppliers / Packagers: | 18 |
Bulk Api Vendors: | 67 |
Clinical Trials: | 109 |
Patent Applications: | 7,259 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for mometasone furoate |
Drug Sales Revenues: | Drug sales revenues for mometasone furoate |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for mometasone furoate |
What excipients (inactive ingredients) are in mometasone furoate? | mometasone furoate excipients list |
DailyMed Link: | mometasone furoate at DailyMed |
Recent Clinical Trials for mometasone furoate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
EMS | Phase 3 |
Suzhou Connect Biopharmaceuticals, Ltd. | Phase 2 |
Seanergy Dermatology Ltd. | Phase 1 |
Pharmacology for mometasone furoate
Drug Class | Corticosteroid |
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for mometasone furoate
Paragraph IV (Patent) Challenges for MOMETASONE FUROATE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
NASONEX | SPRAY, METERED;NASAL | mometasone furoate | 020762 | 2009-08-07 |
ELOCON | LOTION;TOPICAL | mometasone furoate | 019796 | 2004-06-10 |
ELOCON | CREAM;TOPICAL | mometasone furoate | 019625 |
US Patents and Regulatory Information for mometasone furoate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Taro | MOMETASONE FUROATE | mometasone furoate | CREAM;TOPICAL | 076679-001 | Dec 21, 2004 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Perrigo New York | MOMETASONE FUROATE | mometasone furoate | OINTMENT;TOPICAL | 076067-001 | Mar 18, 2002 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Glenmark Generics | MOMETASONE FUROATE | mometasone furoate | LOTION;TOPICAL | 090506-001 | Aug 9, 2010 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Intersect Ent Inc | SINUVA | mometasone furoate | IMPLANT;IMPLANTATION | 209310-001 | Dec 8, 2017 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Perrigo Israel | MOMETASONE FUROATE | mometasone furoate | LOTION;TOPICAL | 077180-001 | Apr 6, 2005 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Intersect Ent Inc | SINUVA | mometasone furoate | IMPLANT;IMPLANTATION | 209310-001 | Dec 8, 2017 | RX | Yes | No | 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 mometasone furoate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Merck Sharp Dohme | ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641-001 | Apr 25, 2014 | Start Trial | Start Trial |
Merck Sharp Dohme | ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641-001 | Apr 25, 2014 | Start Trial | Start Trial |
Merck Sharp Dohme | ASMANEX TWISTHALER | mometasone furoate | POWDER;INHALATION | 021067-002 | Feb 1, 2008 | Start Trial | Start Trial |
Merck Sharp Dohme | ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641-002 | Apr 25, 2014 | Start Trial | Start Trial |
Merck Sharp Dohme | ASMANEX TWISTHALER | mometasone furoate | POWDER;INHALATION | 021067-002 | Feb 1, 2008 | Start Trial | Start Trial |
Merck Sharp Dohme | NASONEX | mometasone furoate | SPRAY, METERED;NASAL | 020762-001 | Oct 1, 1997 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for mometasone furoate
Country | Patent Number | Estimated Expiration |
---|---|---|
European Patent Office | 2298318 | Start Trial |
Japan | 5247428 | Start Trial |
European Patent Office | 2298317 | Start Trial |
Australia | 2004222340 | Start Trial |
Japan | 2006520786 | Start Trial |
World Intellectual Property Organization (WIPO) | 2004082525 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for mometasone furoate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0112669 | 96C0002 | Belgium | Start Trial | PRODUCT NAME: MOMETASONE FUROATE; NAT. REGISTRATION NO/DATE: NL 19601 19950919; FIRST REGISTRATION: GR - 10681/89 19900622 |
0548114 | SPC/GB97/064 | United Kingdom | Start Trial | PRODUCT NAME: MOMETASONE FUROATE MONOHYDRATE; REGISTERED: FR AMM 343012.6 19970219; UK 00201/0216 19970410 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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