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Last Updated: November 2, 2024

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.

Drug Prices for mometasone furoate

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Drug Sales Revenue Trends for mometasone furoate

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Recent Clinical Trials for mometasone furoate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Zheng LiuN/A
MEDA Pharma GmbH & Co. KGPhase 2
Morten Hostrup, PhDN/A

See all mometasone furoate clinical trials

Generic filers with tentative approvals for MOMETASONE FUROATE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up0.05MG/SPRAYSPRAY, 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
Medical Subject Heading (MeSH) Categories 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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