FDA Orange Book ยท active-ingredient family
Mometasone furoate
Mometasone furoate: 8 brands, 25 generics; first approved Apr 30, 1987; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 25 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
8
Generics (ANDA)
25
Listed patents
7
Next patent expiry
Apr 04, 2026
7 mo ago
Brand (NDA) products
Originator applications
- PERRIGO PHARMA INTLNDA 2157122022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05MG/SPRAY SPRAY, METERED NASAL OTC - - ORGANON LLCNDA 20564120193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.10MG/INH AEROSOL, METERED INHALATION Rx - 0.20MG/INH AEROSOL, METERED INHALATION Rx - 0.05MG/INH AEROSOL, METERED INHALATION Rx - - INTERSECT ENT INCNDA 2093102017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1.35MG IMPLANT IMPLANTATION Rx - - ELOCONRLDORGANONNDA 01962520132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% CREAM TOPICAL Discontinued - 0.1% CREAM TOPICAL Discontinued - - ORGANON LLCNDA 02106720082 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.22MG/INH POWDER INHALATION Rx - 0.11MG/INH POWDER INHALATION Rx - - NASONEXRLDORGANON LLCNDA 0207621997
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05MG/SPRAY SPRAY, METERED NASAL Discontinued - - ELOCONRLDORGANONNDA 0197961989
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% LOTION TOPICAL Discontinued - - ELOCONRLDORGANONNDA 0195431987
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% OINTMENT TOPICAL Discontinued -
Generic (ANDA) products (25)
Abbreviated applications
- MOMETASONE FUROATENASPRESSANDA 2117062025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05MG/SPRAY SPRAY, METERED NASAL Rx AB - MOMETASONE FUROATEAUROBINDO PHARMAANDA 2174982024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05MG/SPRAY SPRAY, METERED NASAL Discontinued - - MOMETASONE FUROATEAPOTEXANDA 2174382024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05MG/SPRAY SPRAY, METERED NASAL Discontinued - - MOMETASONE FUROATEAUROBINDO PHARMAANDA 2158782024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05MG/SPRAY SPRAY, METERED NASAL Rx AB - MOMETASONE FUROATEAMNEALANDA 2174602023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05MG/SPRAY SPRAY, METERED NASAL Discontinued - - MOMETASONE FUROATETORRENTANDA 2078992018
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% OINTMENT TOPICAL Rx AB - MOMETASONE FUROATEAMNEAL PHARMSANDA 2079892017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05MG/SPRAY SPRAY, METERED NASAL Rx AB - MOMETASONE FUROATERSAPOTEXANDA 0911612016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.05MG/SPRAY SPRAY, METERED NASAL Rx AB - MOMETASONE FUROATEGLENMARK PHARMS LTDANDA 0905062010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% LOTION TOPICAL Discontinued - - MOMETASONE FUROATEGLENMARK PHARMSANDA 0785412008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% CREAM TOPICAL Discontinued - - MOMETASONE FUROATEGLENMARK PHARMSANDA 0785712008
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% OINTMENT TOPICAL Discontinued - - MOMETASONE FUROATEFOUGERA PHARMSANDA 0759192007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% LOTION TOPICAL Rx AB - MOMETASONE FUROATECOSETTE PHARMS NCANDA 0776782007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% LOTION TOPICAL Discontinued - - MOMETASONE FUROATEENCUBEANDA 0764992007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% LOTION TOPICAL Rx AB - MOMETASONE FUROATECHARTWELL MOLECULARANDA 0765912007
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% CREAM TOPICAL Discontinued - - MOMETASONE FUROATECOSETTE PHARMS NCANDA 0774012006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% OINTMENT TOPICAL Rx AB - MOMETASONE FUROATERSCOSETTE PHARMS NCANDA 0774472006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% CREAM TOPICAL Rx AB - MOMETASONE FUROATESUN PHARMA CANADAANDA 0767882006
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% LOTION TOPICAL Discontinued - - MOMETASONE FUROATEFOUGERA PHARMSANDA 0761712005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% CREAM TOPICAL Discontinued - - MOMETASONE FUROATERSPADAGIS ISRAELANDA 0771802005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% LOTION TOPICAL Rx AB - MOMETASONE FUROATEFOUGERA PHARMSANDA 0770612005
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% OINTMENT TOPICAL Rx AB - MOMETASONE FUROATESUN PHARMA CANADAANDA 0766792004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% CREAM TOPICAL Rx AB - MOMETASONE FUROATESUN PHARMA CANADAANDA 0766242004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% OINTMENT TOPICAL Discontinued - - MOMETASONE FUROATEENCUBEANDA 0764812003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% OINTMENT TOPICAL Rx AB - MOMETASONE FUROATERSPADAGIS USANDA 0760672002
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1% OINTMENT TOPICAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9585681 | 7 mo ago | U-2272 | |
| 7544192 | in 1 mo | U-2272 | |
| 8025635 | in 8 mo | ProductU-2272 | |
| 10357640 | in 5 yr | U-2272 | |
| 8763222 | in 5 yr 5 mo | Product | |
| 10406332 | in 7 yr 6 mo | Product | |
| 10232152 | in 8 yr 3 mo | ProductU-2272 |
Approval history
FDA approval span
First approval
40 yr 1 mo ago
Most recent approval
1 yr 6 mo ago
Approvals span 1987โ2025 across 33 FDA applications.
Brand (NDA) 824%
Generic (ANDA) 2576%
Mometasone furoate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
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