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 Pharms Inc, Taro, Intersect Ent Inc, Encube, Glenmark Pharms Ltd, Padagis Israel, Padagis Us, Torrent, Amneal, Amneal Pharms, Apotex, Aurobindo Pharma, Perrigo Pharma Intl, and Glenmark Speclt, and is included in thirty-two 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: | 19 |
NDAs: | 32 |
Drug Master File Entries: | 27 |
Finished Product Suppliers / Packagers: | 23 |
Raw Ingredient (Bulk) Api Vendors: | 79 |
Clinical Trials: | 143 |
Patent Applications: | 7,036 |
Drug Prices: | Drug price trends 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 |
---|---|
Zheng Liu | N/A |
MEDA Pharma GmbH & Co. KG | Phase 2 |
Morten Hostrup, PhD | N/A |
Generic filers with tentative approvals for MOMETASONE FUROATE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Intersect Ent Inc | SINUVA | mometasone furoate | IMPLANT;IMPLANTATION | 209310-001 | Dec 8, 2017 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Intersect Ent Inc | SINUVA | mometasone furoate | IMPLANT;IMPLANTATION | 209310-001 | Dec 8, 2017 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Encube | MOMETASONE FUROATE | mometasone furoate | OINTMENT;TOPICAL | 076481-001 | Nov 14, 2003 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Taro | MOMETASONE FUROATE | mometasone furoate | OINTMENT;TOPICAL | 076624-001 | Dec 3, 2004 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Intersect Ent Inc | SINUVA | mometasone furoate | IMPLANT;IMPLANTATION | 209310-001 | Dec 8, 2017 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Organon Llc | ASMANEX TWISTHALER | mometasone furoate | POWDER;INHALATION | 021067-001 | Mar 30, 2005 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Glenmark Speclt | RYALTRIS | mometasone furoate; olopatadine hydrochloride | SPRAY, METERED;NASAL | 211746-001 | Jan 13, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 | ELOCON | mometasone furoate | LOTION;TOPICAL | 019796-001 | Mar 30, 1989 | ⤷ Sign Up | ⤷ Sign Up |
Organon Llc | NASONEX | mometasone furoate | SPRAY, METERED;NASAL | 020762-001 | Oct 1, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Organon Llc | ASMANEX HFA | mometasone furoate | AEROSOL, METERED;INHALATION | 205641-001 | Apr 25, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Organon Llc | ASMANEX TWISTHALER | mometasone furoate | POWDER;INHALATION | 021067-001 | Mar 30, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Organon Llc | NASONEX | mometasone furoate | SPRAY, METERED;NASAL | 020762-001 | Oct 1, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Organon Llc | ASMANEX TWISTHALER | mometasone furoate | POWDER;INHALATION | 021067-001 | Mar 30, 2005 | ⤷ Sign Up | ⤷ Sign Up |
Organon Llc | ASMANEX TWISTHALER | mometasone furoate | POWDER;INHALATION | 021067-001 | Mar 30, 2005 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for mometasone furoate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 20080005939 | DEVICE AND METHODS FOR TREATING PARANASAL SINUS CONDITIONS | ⤷ Sign Up |
Australia | 2006231506 | Device and methods for treating paranasal sinus conditions | ⤷ Sign Up |
European Patent Office | 3636227 | SYSTÈMES ET DISPOSITIFS DE TRAITEMENT D'UNE AFFECTION SINUSALE (SYSTEMS AND DEVICES FOR TREATING A SINUS CONDITION) | ⤷ Sign Up |
Japan | 2018114313 | 副鼻腔状態を処置するためのシステム、デバイスおよび方法 (SYSTEMS, DEVICES AND METHODS FOR TREATING SINUS CONDITION) | ⤷ Sign Up |
European Patent Office | 3103502 | DISPOSITIFS EXPANSIBLES ET PROCÉDÉS ASSOCIÉS (EXPANDABLE DEVICES AND METHODS THEREFOR) | ⤷ Sign Up |
European Patent Office | 2298318 | Dispositifs et procédés de traitement des affections sinus paranasaux (Device and methods for treating paranasal sinus conditions) | ⤷ Sign Up |
European Patent Office | 2298319 | Dispositifs et procédés de traitement des affections sinus paranasaux (Device and methods for treating paranasal sinus conditions) | ⤷ Sign Up |
>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 | ⤷ Sign Up | PRODUCT NAME: MOMETASONE FUROATE MONOHYDRATE; REGISTERED: FR AMM 343012.6 19970219; UK 00201/0216 19970410 |
3043773 | 2190041-0 | Sweden | ⤷ Sign Up | PRODUCT NAME: MOMETASONE OR A SALT THEREOF AND OLOPATADINE OR A SALT THEREOF; NAT. REG. NO/DATE: MT NR 60226 20210519; FIRST REG.: AT APPROVAL NR 140638 20210426 |
3043773 | 132021000000191 | Italy | ⤷ Sign Up | 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 |
0112669 | 96C0002 | Belgium | ⤷ Sign Up | PRODUCT NAME: MOMETASONE FUROATE; NAT. REGISTRATION NO/DATE: NL 19601 19950919; FIRST REGISTRATION: GR - 10681/89 19900622 |
3043773 | 21C1057 | France | ⤷ Sign Up | 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 |
3043773 | 2022C/520 | Belgium | ⤷ Sign Up | PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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