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Last Updated: March 29, 2024

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 five 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.
Summary for 022051
Tradename:FLONASE SENSIMIST ALLERGY RELIEF
Applicant:Haleon Us Holdings
Ingredient:fluticasone furoate
Patents:5
Formulation / Manufacturing:see details
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
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:OTCDosage:SPRAY, METERED;NASALStrength0.0275MG/SPRAY
Approval Date:Aug 2, 2016TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Apr 5, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Oct 15, 2028Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Try a TrialPatent Expiration:Jul 15, 2028Product Flag?YSubstance 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 ⤷  Try a Trial ⤷  Try a Trial
Haleon Us Holdings FLONASE SENSIMIST ALLERGY RELIEF fluticasone furoate SPRAY, METERED;NASAL 022051-002 Aug 2, 2016 ⤷  Try a Trial ⤷  Try a Trial
Haleon Us Holdings FLONASE SENSIMIST ALLERGY RELIEF fluticasone furoate SPRAY, METERED;NASAL 022051-002 Aug 2, 2016 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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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.