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MOMETASONE FUROATE - Generic Drug Details
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What are the generic drug 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 | ||||
| >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 |
| >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 |
| >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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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