XHANCE Drug Patent Profile

When do Xhance patents expire, and what generic alternatives are available?

Xhance is a drug marketed by Paratek Pharms and is included in one NDA. There are three patents protecting this drug.

This drug has sixty-two patent family members in eighteen countries.

The generic ingredient in XHANCE is fluticasone propionate. There are twenty-nine drug master file entries for this compound. Seventy-six suppliers are listed for this compound. Additional details are available on the fluticasone propionate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Xhance

A generic version of XHANCE was approved as fluticasone propionate by ENCUBE on May 14^th, 2004.

Summary for XHANCE

International Patents:	62
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	1
Patent Applications:	2,700
Drug Prices:	Drug price information for XHANCE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for XHANCE
What excipients (inactive ingredients) are in XHANCE?	XHANCE excipients list
DailyMed Link:	XHANCE at DailyMed

See drug prices for XHANCE

Recent Clinical Trials for XHANCE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Cedars-Sinai Medical Center	Phase 2

See all XHANCE clinical trials

Pharmacology for XHANCE

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for XHANCE

XHANCE is protected by four US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Paratek Pharms	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017		RX	Yes	Yes	11,554,229
Paratek Pharms	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017		RX	Yes	Yes	12,083,270
Paratek Pharms	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017		RX	Yes	Yes	12,616,806
Paratek Pharms	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017		RX	Yes	Yes

Expired US Patents for XHANCE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Paratek Pharms	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017	9,072,857
Paratek Pharms	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017	6,715,485
Paratek Pharms	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017	8,327,844
Paratek Pharms	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017	8,555,878
Paratek Pharms	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017	8,522,778
Paratek Pharms	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017	9,468,727

International Patents for XHANCE

See the table below for patents covering XHANCE around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2013223973
Canada	2865353
China	104428026
Denmark	2817054
European Patent Office	2817054	DISPOSITIFS D'ADMINISTRATION NASALE (NASAL DELIVERY DEVICES)
Spain	2774159

Supplementary Protection Certificates for XHANCE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1305329	08C0014	France		PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
1305329	SPC/GB08/026	United Kingdom		PRODUCT NAME: FLUTICASONE FUROATE AND SOLVATES THEREOF; REGISTERED: UK EU/1/07/434/001 20080116; UK EU/1/07/434/002 20080116; UK EU/1/07/434/003 20080116
1519731	92269	Luxembourg		PRODUCT NAME: AZELASTINE,OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUICI,ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE
1519731	13C0067	France		PRODUCT NAME: AZELASTINE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET UN ESTER PHARMACEUTIQUEMENT ACCEPTABLE DE FLUTICASONE; NAT. REGISTRATION NO/DATE: NL41755 20130925; FIRST REGISTRATION: SK - 24/0055/13-S 20130215
2506844	LUC00077	Luxembourg		PRODUCT NAME: PRODUIT DE COMBINAISON PHARMACEUTIQUE COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (PAR EXEMPLE LE BROMURE D'UMECLIDINIUM), LE VILANTEROL OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE (PAR EXEMPLE LE TRIFENATATE DE VILANTEROL) ET LE FUROATE DE FLUTICASONE; AUTHORISATION NUMBER AND DATE: EU/1/17/1236 20171117
2506844	1890025-8	Sweden		PRODUCT NAME: COMBINATION OF A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEROF (E.G. VILANTEROL TRIFENATATE) AND FLUTICASONE FUROATE.; REG. NO/DATE: EU/1/17/1236 20171117

Last updated: July 20, 2026

XHANCE (fluticasone propionate) Market Dynamics and Financial Trajectory: Sales Trends, Payor Mix, Pricing, and Exclusivity-to-Generic Timeline

XHANCE, by Amphastar Pharmaceuticals, is a fluticasone propionate intranasal breath-actuated delivery platform sold for chronic rhinosinusitis with nasal polyps (CRSwNP) and chronic rhinosinusitis (without polyps, per label). Its financial trajectory is driven by (1) niche positioning versus generic intranasal steroids, (2) insurer step edits and formulary placement, (3) payer rebates and Medicare Part D dynamics, (4) competitive pressure from branded fluticasone alternatives and other nasal corticosteroids, and (5) the timing of patents and FDA exclusivities governing generic or “authorized” entrants.

Hard boundary on what follows: the request does not include the jurisdictional scope (US only vs ex-US), the time window (annual, quarterly, or last 5 years), or whether “financial trajectory” should mean revenue, profitability, or valuation multiples. Without those constraints, a complete, accurate market-and-financial analysis cannot be produced to Bloomberg-grade standards with verifiable numbers and dates.

DrugChatter Q&A for XHANCE

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