XHANCE Drug Patent Profile

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

Xhance is a drug marketed by Optinose Us Inc and is included in one NDA. There are fifteen patents protecting this drug.

This drug has three hundred and thirty-four patent family members in twenty-nine countries.

The generic ingredient in XHANCE is fluticasone propionate. There are twenty-nine drug master file entries for this compound. Seventy-two 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 FOUGERA PHARMS on May 14^th, 2004.

Summary for XHANCE

International Patents:	334
US Patents:	15
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	1
Patent Applications:	5,455
Drug Prices:	Drug price information 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 fifteen 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
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017		RX	Yes	Yes
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017		RX	Yes	Yes
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017		RX	Yes	Yes			Y
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017		RX	Yes	Yes			Y
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017		RX	Yes	Yes			Y
Optinose Us Inc	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
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017
Optinose Us Inc	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017

International Patents for XHANCE

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

Country	Patent Number	Title	Estimated Expiration
United Kingdom	201018442
South Korea	20150138286	코 투여 (NASAL ADMINISTRATION)
United Kingdom	2405800	Nasal devices
World Intellectual Property Organization (WIPO)	2007083073
Austria	427130
European Patent Office	3799909	DISPOSITIFS D'ADMINISTRATION NASALE (NASAL DELIVERY DEVICES)

Supplementary Protection Certificates for XHANCE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2506844	18C1022	France		PRODUCT NAME: COMBINAISON COMPRENANT UN SEL PHARMACEUTIQUEMENT ACCEPTABLE D'UMECLIDINIUM (EN PARTICULIER LE BROMURE D'UMECLIDINIUM), DU VILANTEROL OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (EN PARTICULIER LE TRIFENATATE DE VILANTEROL), ET DU FUROATE DE FLUTICASONE; REGISTRATION NO/DATE: EU/1/17/1236 20171117
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
1519731	132013902182575	Italy		PRODUCT NAME: AZELASTINA CLORIDRATO/FLUTICASONE PROPIONATO(DYMISTA); AUTHORISATION NUMBER(S) AND DATE(S): 2011/07125-REG, 20111024;041808015/M-027/M-039/M-041/M, 20130527
2506844	SPC/GB18/020	United Kingdom		PRODUCT NAME: A PHARMACEUTICAL COMBINATION PRODUCT COMPRISING A PHARMACEUTICALLY ACCEPTABLE SALT OF UMECLIDINIUM (E.G. UMECLIDINIUM BROMIDE), VILANTEROL OR A PHARMACEUTICALLY ACCETPABLE SALT THEREOF (E.G. VILANTEROL TRIFENATATE), AND FLUTICASONE FUROATE; REGISTERED: UK EU/1/17/1236/001(NI) 20171117; UK EU/1/17/1236/002(NI) 20171117; UK EU/1/17/1236/003(NI) 20171117; UK PLGB 19494/0287 20171117
1305329	08C0014	France		PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
2506844	132018000000341	Italy		PRODUCT NAME: UN PRODOTTO DI COMBINAZIONE FARMACEUTICA COMPRENDENTE UN SALE FARMACEUTICAMENTE ACCETTABILE DI UMECLIDINIO (AD ESEMPIO BROMURO DI UMECLIDINIO), VILANTEROLO O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE (AD ESEMPIO VILANTEROLO TRIFENATATO) E UN FUROATO(TRELEGY ELLIPTA - FLUTICASONE FUROATO/UMECLIDINIO/VILANTEROLO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1236, 20171117

XHANCE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for XHANCE

Introduction

XHANCE, developed by Optinose, is a significant player in the pharmaceutical market, particularly in the treatment of nasal polyps and chronic sinusitis. Here, we will delve into the market dynamics and financial trajectory of XHANCE, highlighting key milestones, financial performance, and future outlook.

Market Need and Indications

XHANCE, a fluticasone propionate nasal spray, has been approved for the treatment of nasal polyps and, more recently, for chronic rhinosinusitis without nasal polyps in patients 18 years of age and older. This approval addresses a critical market need, as chronic sinusitis is one of the most common diagnoses in adult outpatient medicine, yet it had no FDA-approved prescription treatment until XHANCE[3].

Financial Performance: 2022

In 2022, Optinose reported $76.3 million in net revenue from XHANCE sales, a 4% increase from the $73.7 million in 2021. However, the fourth quarter of 2022 saw a 7% decrease in net revenue compared to the same period in 2021, primarily due to a decline in prescription volumes[1].

Financial Performance: 2023

For the full year 2023, Optinose expected XHANCE net revenues to be between $62.0 to $68.0 million. This guidance did not include potential revenues from the treatment of chronic sinusitis, as the label expansion was still pending at the time[1].

Financial Performance: 2024

First Quarter 2024

The first quarter of 2024 saw a significant increase in XHANCE net revenue, with $14.9 million reported, a 26% increase compared to the first quarter of 2023. This growth was attributed to the recent FDA approval for the treatment of chronic rhinosinusitis without nasal polyps[2][3].

Third Quarter 2024

Despite a positive inflection in new prescriptions starting in September 2024, the third quarter revenue growth was only 3% year-over-year, reaching $20.4 million. This led to a downward revision in the full-year 2024 revenue guidance from $85-90 million to $75-79 million[5].

Revenue Guidance and Projections

Full-Year 2024 Guidance

Optinose has revised its full-year 2024 XHANCE net revenue guidance to be between $75.0 to $79.0 million, reflecting the slower-than-expected growth in the third quarter. However, the company expects the average net revenue per prescription to be approximately $270, an increase from previous expectations[5].

Peak Year Projections

The company is optimistic about long-term growth, projecting peak year XHANCE net revenues of at least $300 million from the current specialist-focused prescriber audience[3].

Operating Expenses

To align with the revised revenue guidance, Optinose has reduced its operating expenses. For 2023, the company aimed to reduce total GAAP operating expenses by approximately $30.0 million or 25% compared to 2022. For 2024, the expected total GAAP operating expenses are between $90.0 to $93.0 million, with stock-based compensation estimated at around $6.0 million[1][5].

Cash Position and Financial Health

As of March 31, 2024, Optinose had $51.6 million in cash and cash equivalents, which does not include the approximately $55 million in net proceeds from a registered direct offering that closed on May 10, 2024. However, the company faces potential non-compliance with financial covenants and has expressed substantial doubt about its ability to continue as a going concern[2][5].

Market Strategy and Launch

Following the FDA approval for chronic sinusitis, Optinose has optimized its sales alignment towards a chronic sinusitis call target universe and partnered with a specialty pharmacy hub to enhance patient and physician experience. This strategy aims to leverage the existing commercial infrastructure with minimal incremental spend[4].

Regulatory Milestones

• sNDA Submission: Optinose submitted a supplemental New Drug Application (sNDA) for XHANCE label expansion in February 2023[1].
• FDA Approval: XHANCE was approved by the FDA in March 2024 for the treatment of chronic rhinosinusitis without nasal polyps[3].

Industry Impact and Expert Insights

"The recent FDA approval of XHANCE as the first and only approved drug treatment for chronic sinusitis (CS) is a landmark achievement," said Ramy Mahmoud, MD, MPH, CEO of Optinose. This approval highlights the significant impact XHANCE can have on a large patient population previously without an approved prescription treatment[4].

Challenges and Future Outlook

Despite the positive developments, Optinose faces challenges such as slower-than-expected revenue growth and potential compliance issues with financial covenants. However, the company remains optimistic about achieving positive income from operations (GAAP) for the full year 2025[5].

Key Takeaways

• Revenue Growth: XHANCE has shown growth, particularly in the first quarter of 2024, but faced a downward revision in full-year 2024 guidance.
• Market Expansion: The FDA approval for chronic sinusitis has significantly expanded the potential market for XHANCE.
• Operational Efficiency: Optinose has reduced operating expenses to align with revised revenue guidance.
• Financial Health: The company faces financial challenges but maintains a strong cash position.
• Future Projections: Peak year revenues are projected to be at least $300 million.

FAQs

What is XHANCE used for?

XHANCE is a fluticasone propionate nasal spray used for the treatment of nasal polyps and chronic rhinosinusitis without nasal polyps in patients 18 years of age and older.

What was the revenue from XHANCE in 2022?

In 2022, Optinose reported $76.3 million in net revenue from XHANCE sales.

What is the revised full-year 2024 revenue guidance for XHANCE?

The revised full-year 2024 XHANCE net revenue guidance is between $75.0 to $79.0 million.

How has the FDA approval impacted XHANCE?

The FDA approval for chronic sinusitis has significantly expanded the potential market for XHANCE, addressing a large population previously without an approved prescription treatment.

What are the peak year revenue projections for XHANCE?

Optinose projects peak year XHANCE net revenues of at least $300 million from the current specialist-focused prescriber audience.

Sources

1. Optinose Reports Fourth Quarter and Full Year 2022 Financial Results and Recent Operational Highlights. Biospace.
2. Optinose Reports First Quarter 2024 Financial Results and Recent Operational Highlights. Biospace.
3. Optinose Reports First Quarter 2024 Financial Results and Recent Operational Highlights. Optinose Investor Relations.
4. Optinose Provides Corporate Update on XHANCE Launch and Outlook and Announces Preliminary First Quarter 2024 XHANCE Net Revenue of $14.9 million. Optinose Investor Relations.
5. Optinose Slashes 2024 Revenue Guidance Despite Q3 Growth. Stock Titan.