Details for New Drug Application (NDA): 022051
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NDA 022051 describes FLONASE SENSIMIST ALLERGY RELIEF, which is a drug marketed by Haleon Us Holdings and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug. Additional details are available on the FLONASE SENSIMIST ALLERGY RELIEF profile page.
The generic ingredient in FLONASE SENSIMIST ALLERGY RELIEF is fluticasone furoate. There are twenty-nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the fluticasone furoate profile page.
The generic ingredient in FLONASE SENSIMIST ALLERGY RELIEF is fluticasone furoate. There are twenty-nine drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the fluticasone furoate profile page.
Summary for 022051
| Tradename: | FLONASE SENSIMIST ALLERGY RELIEF |
| Applicant: | Haleon Us Holdings |
| Ingredient: | fluticasone furoate |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 022051
Generic Entry Date for 022051*:
Constraining patent/regulatory exclusivity:
Dosage:
SPRAY, METERED;NASAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Pharmacology for NDA: 022051
| Mechanism of Action | Corticosteroid Hormone Receptor Agonists |
Suppliers and Packaging for NDA: 022051
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FLONASE SENSIMIST ALLERGY RELIEF | fluticasone furoate | SPRAY, METERED;NASAL | 022051 | NDA | Haleon US Holdings LLC | 0135-0615 | 0135-0615-01 | 1 BOTTLE in 1 CARTON (0135-0615-01) / 30 SPRAY, METERED in 1 BOTTLE |
| FLONASE SENSIMIST ALLERGY RELIEF | fluticasone furoate | SPRAY, METERED;NASAL | 022051 | NDA | Haleon US Holdings LLC | 0135-0615 | 0135-0615-02 | 1 BOTTLE in 1 PACKAGE (0135-0615-02) / 60 SPRAY, METERED in 1 BOTTLE |
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SPRAY, METERED;NASAL | Strength | 0.0275MG/SPRAY | ||||
| Approval Date: | Aug 2, 2016 | TE: | RLD: | Yes | |||||
| Patent: | 8,062,264 | Patent Expiration: | Apr 5, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 8,147,461 | Patent Expiration: | Oct 15, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 8,347,879 | Patent Expiration: | Jul 15, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 022051
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Haleon Us Holdings | FLONASE SENSIMIST ALLERGY RELIEF | fluticasone furoate | SPRAY, METERED;NASAL | 022051-002 | Aug 2, 2016 | 6,858,596 | ⤷ Subscribe |
| Haleon Us Holdings | FLONASE SENSIMIST ALLERGY RELIEF | fluticasone furoate | SPRAY, METERED;NASAL | 022051-002 | Aug 2, 2016 | 9,320,862 | ⤷ Subscribe |
| Haleon Us Holdings | FLONASE SENSIMIST ALLERGY RELIEF | fluticasone furoate | SPRAY, METERED;NASAL | 022051-002 | Aug 2, 2016 | 7,541,350 | ⤷ Subscribe |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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