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 eight branded drugs marketed by Organon Llc, Organon, Anda Repository, Cosette, Fougera Pharms, Glenmark Generics, Taro, Intersect Ent Inc, Encube, Padagis Israel, Padagis Us, Torrent, Amneal, Amneal Pharms, Apotex, Perrigo Pharma Intl, and Glenmark Specialty, and is included in thirty NDAs. There are twenty-seven 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 twenty-seven drug master file entries for mometasone furoate. Twenty-three suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for mometasone furoate
International Patents: | 47 |
US Patents: | 27 |
Tradenames: | 8 |
Applicants: | 17 |
NDAs: | 30 |
Drug Master File Entries: | 27 |
Finished Product Suppliers / Packagers: | 23 |
Raw Ingredient (Bulk) Api Vendors: | 79 |
Clinical Trials: | 140 |
Patent Applications: | 7,358 |
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 |
---|---|
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. | Phase 2 |
Centre hospitalier de l'Université de Montréal (CHUM) | Phase 4 |
Sandoz | Phase 1 |
Generic filers with tentative approvals for MOMETASONE FUROATE
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 0.05MG/SPRAY | SPRAY, METERED;NASAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for mometasone furoate
Drug Class | Corticosteroid |
Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Medical Subject Heading (MeSH) Categories for mometasone furoate
Anatomical Therapeutic Chemical (ATC) Classes for mometasone furoate
Paragraph IV (Patent) Challenges for MOMETASONE FUROATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
NASONEX | Nasal Spray | mometasone furoate | 50 mcg/ Spray | 020762 | 1 | 2009-08-07 |
ELOCON | Topical Solution (Lotion) | mometasone furoate | 0.1% | 019796 | 1 | 2004-06-10 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Glenmark Specialty | RYALTRIS | mometasone furoate; olopatadine hydrochloride | SPRAY, METERED;NASAL | 211746-001 | Jan 13, 2022 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Cosette | MOMETASONE FUROATE | mometasone furoate | LOTION;TOPICAL | 077678-001 | Nov 21, 2007 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Fougera Pharms | MOMETASONE FUROATE | mometasone furoate | OINTMENT;TOPICAL | 077061-001 | Mar 28, 2005 | AB | RX | No | No | ⤷ 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 mometasone furoate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Organon Llc | ASMANEX TWISTHALER | mometasone furoate | POWDER;INHALATION | 021067-001 | Mar 30, 2005 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon Llc | ASMANEX TWISTHALER | mometasone furoate | POWDER;INHALATION | 021067-002 | Feb 1, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon Llc | NASONEX | mometasone furoate | SPRAY, METERED;NASAL | 020762-001 | Oct 1, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for mometasone furoate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Canada | 3001814 | DISPOSITIFS EXPANSIBLES ET PROCEDES POUR LES UTILISER (EXPANDABLE DEVICES AND METHODS THEREFOR) | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2006107957 | ⤷ Try a Trial | |
European Patent Office | 1871383 | DISPOSITIFS ET PROCEDES DE TRAITEMENT DES AFFECTIONS SINUS PARANASAUX (DEVICE AND METHODS FOR TREATING PARANASAL SINUS CONDITIONS) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for mometasone furoate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0548114 | SPC/GB97/064 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: MOMETASONE FUROATE MONOHYDRATE; REGISTERED: FR AMM 343012.6 19970219; UK 00201/0216 19970410 |
3043773 | 132021000000191 | Italy | ⤷ Try a Trial | PRODUCT NAME: MOMETASONE O UN SUO SALE E OLOPATADINA O UN SUO SALE(RYALTRIS); AUTHORISATION NUMBER(S) AND DATE(S): 048499014, 048499026, 048499038, 20210726;140638, 20210426 |
3043773 | 21C1057 | France | ⤷ Try a Trial | PRODUCT NAME: MOMETASONE OU L'UN DE SES SELS AVEC OLOPATADINE OU L'UN DE SES SELS; NAT. REGISTRATION NO/DATE: NL52121 20211026; FIRST REGISTRATION: AT - 140638 20210426 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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