FDA Orange Book · active-ingredient family
Mometasone furoate
Mometasone furoate is approved as 8 brand and 25 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:NASONEX 24HR ALLERGY · NDA 215712
8
Brand (NDA)
25
Generics (ANDA)
7
Listed patents
0
Exclusivity periods
Brand (NDA) products · aerosol, metered, cream, implant, lotion, ointment, powder, spray, metered
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NASONEX 24HR ALLERGYRLD | PERRIGO PHARMA INTL | NDA 215712 | — | Mar 17, 2022 | |
| ASMANEX HFARLD×3 | ORGANON LLC | NDA 205641 | — | Aug 12, 2019 | |
| SINUVARLD | INTERSECT ENT INC | NDA 209310 | — | Dec 08, 2017 | |
| ELOCONRLD×2 | ORGANON | NDA 019625 | — | Apr 19, 2013 | |
| ASMANEX TWISTHALERRLD×2 | ORGANON LLC | NDA 021067 | — | Feb 01, 2008 | |
| NASONEXRLD | ORGANON LLC | NDA 020762 | — | Oct 01, 1997 | |
| ELOCONRLD | ORGANON | NDA 019796 | — | Mar 30, 1989 | |
| ELOCONRLD | ORGANON | NDA 019543 | — | Apr 30, 1987 |
Generic (ANDA) products (25)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MOMETASONE FUROATE | NASPRESS | ANDA 211706 | — | May 15, 2025 | |
| MOMETASONE FUROATE | AUROBINDO PHARMA | ANDA 217498 | — | Nov 22, 2024 | |
| MOMETASONE FUROATE | APOTEX | ANDA 217438 | — | Apr 23, 2024 | |
| MOMETASONE FUROATE | AUROBINDO PHARMA | ANDA 215878 | AB | Mar 18, 2024 | |
| MOMETASONE FUROATE | AMNEAL | ANDA 217460 | — | Jun 14, 2023 | |
| MOMETASONE FUROATE | TORRENT | ANDA 207899 | AB | Jul 13, 2018 | |
| MOMETASONE FUROATE | AMNEAL PHARMS | ANDA 207989 | AB | Apr 03, 2017 | |
| MOMETASONE FUROATE | APOTEX | ANDA 091161 | AB | Mar 22, 2016 | |
| MOMETASONE FUROATE | GLENMARK PHARMS LTD | ANDA 090506 | — | Aug 09, 2010 | |
| MOMETASONE FUROATE | GLENMARK PHARMS | ANDA 078541 | — | May 28, 2008 | |
| MOMETASONE FUROATE | GLENMARK PHARMS | ANDA 078571 | — | May 28, 2008 | |
| MOMETASONE FUROATE | FOUGERA PHARMS | ANDA 075919 | AB | Nov 29, 2007 | |
| MOMETASONE FUROATE | COSETTE | ANDA 077678 | — | Nov 21, 2007 | |
| MOMETASONE FUROATE | ENCUBE | ANDA 076499 | AB | Nov 21, 2007 | |
| MOMETASONE FUROATE | CHARTWELL MOLECULAR | ANDA 076591 | — | Apr 18, 2007 | |
| MOMETASONE FUROATE | COSETTE PHARMS NC | ANDA 077401 | AB | Jun 20, 2006 | |
| MOMETASONE FUROATE | COSETTE PHARMS NC | ANDA 077447 | AB | May 22, 2006 | |
| MOMETASONE FUROATE | SUN PHARMA CANADA | ANDA 076788 | — | Mar 15, 2006 | |
| MOMETASONE FUROATE | FOUGERA PHARMS | ANDA 076171 | — | Apr 08, 2005 | |
| MOMETASONE FUROATE | PADAGIS ISRAEL | ANDA 077180 | AB | Apr 06, 2005 | |
| MOMETASONE FUROATE | FOUGERA PHARMS | ANDA 077061 | AB | Mar 28, 2005 | |
| MOMETASONE FUROATE | SUN PHARMA CANADA | ANDA 076679 | AB | Dec 21, 2004 | |
| MOMETASONE FUROATE | SUN PHARMA CANADA | ANDA 076624 | — | Dec 03, 2004 | |
| MOMETASONE FUROATE | ENCUBE | ANDA 076481 | AB | Nov 14, 2003 | |
| MOMETASONE FUROATE | PADAGIS US | ANDA 076067 | AB | Mar 18, 2002 |
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9585681 | Apr 04, 2026 | 3 mo ago | U-2272 |
| 7544192 | Nov 29, 2026 | in 5 mo | U-2272 |
| 8025635 | Jun 12, 2027 | in 1 yr | ProductU-2272 |
| 10357640 | Oct 03, 2031 | in 5 yr 4 mo | U-2272 |
| 8763222 | Feb 08, 2032 | in 5 yr 9 mo | Product |
| 10406332 | Mar 13, 2034 | in 7 yr 10 mo | Product |
| 10232152 | Nov 24, 2034 | in 8 yr 7 mo | ProductU-2272 |
Mometasone furoate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
