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Last Updated: March 29, 2024

Mometasone furoate - Generic Drug Details


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What are the generic drug sources for mometasone furoate and what is the scope of freedom to operate?

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.

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
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.Phase 2
Centre hospitalier de l'Université de Montréal (CHUM)Phase 4
SandozPhase 1

See all mometasone furoate clinical trials

Generic filers with tentative approvals for MOMETASONE FUROATE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial0.05MG/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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Encube MOMETASONE FUROATE mometasone furoate OINTMENT;TOPICAL 076481-001 Nov 14, 2003 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Intersect Ent Inc SINUVA mometasone furoate IMPLANT;IMPLANTATION 209310-001 Dec 8, 2017 RX Yes 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 NASONEX mometasone furoate SPRAY, METERED;NASAL 020762-001 Oct 1, 1997 ⤷  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
Intersect Ent Inc SINUVA mometasone furoate IMPLANT;IMPLANTATION 209310-001 Dec 8, 2017 ⤷  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
European Patent Office 3636227 SYSTÈMES ET DISPOSITIFS DE TRAITEMENT D'UNE AFFECTION SINUSALE (SYSTEMS AND DEVICES FOR TREATING A SINUS CONDITION) ⤷  Try a Trial
Singapore 11201507476T SYSTEMS, DEVICES, AND METHOD FOR TREATING A SINUS CONDITION ⤷  Try a Trial
Australia 2006231506 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
0112669 96C0002 Belgium ⤷  Try a Trial PRODUCT NAME: MOMETASONE FUROATE; NAT. REGISTRATION NO/DATE: NL 19601 19950919; FIRST REGISTRATION: GR - 10681/89 19900622
3043773 2190041-0 Sweden ⤷  Try a Trial 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 2022C/520 Belgium ⤷  Try a Trial 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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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.