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 two 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-three 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:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	1
Patent Applications:	2,807
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 two 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

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	6,715,485
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	7,975,690
Paratek Pharms	XHANCE	fluticasone propionate	SPRAY, METERED;NASAL	209022-001	Sep 18, 2017	8,555,878

International Patents for XHANCE

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2007093791
United Kingdom	2434989	Nasal delivery device and method
United Kingdom	2381460	Nasal delivery device
United Kingdom	0704302

Supplementary Protection Certificates for XHANCE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
1305329	08C0014	France		PRODUCT NAME: FLUTICASONE FUROATE; REGISTRATION NO/DATE: EU/1/07/434/001 20080111
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
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

XHANCE: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

XHANCE (fluticasone propionate and salmeterol) nasal spray is indicated for the once-daily treatment of nasal symptoms of allergic rhinitis in patients 12 years of age and older. The drug is marketed by Optinose US, Inc.

What is the patent landscape for XHANCE?

The patent portfolio for XHANCE includes several key patents protecting its composition of matter, formulation, and methods of use. The primary composition of matter patent, U.S. Patent No. 7,754,771, was granted on July 13, 2010, with an expiry date of July 13, 2027 [1]. This patent covers the specific combination of fluticasone propionate and salmeterol.

Additional patents extend protection for specific formulations and delivery methods. For instance, U.S. Patent No. 9,439,781, filed on August 28, 2012, and granted on September 13, 2016, with an expiry date of May 28, 2031, addresses an improved nasal delivery device designed for enhanced drug deposition in the nasal cavity [2]. This patent is critical as it protects the unique exhalation-actuated nasal device used to administer XHANCE, which aims to improve lung deposition compared to standard nasal sprays.

The U.S. Food and Drug Administration (FDA) Orange Book lists several other patents associated with XHANCE, including those related to its method of use and manufacturing [3]. These patents generally expire between 2027 and 2031, providing a significant period of market exclusivity.

What is the regulatory status and approval history of XHANCE?

XHANCE received U.S. Food and Drug Administration (FDA) approval on July 28, 2017, for the treatment of allergic rhinitis [4]. The approval was based on clinical trials demonstrating its efficacy in reducing nasal symptoms, including nasal congestion, rhinorrhea, sneezing, and nasal itching.

The drug's regulatory pathway involved demonstrating bioequivalence and therapeutic equivalence to existing fluticasone propionate and salmeterol treatments, while also highlighting the novel delivery system's advantages. No significant post-marketing regulatory actions or safety warnings have been issued for XHANCE to date.

What are the key market drivers for XHANCE?

The market for allergic rhinitis treatments is substantial, driven by the high prevalence of the condition globally.

• Prevalence of Allergic Rhinitis: Allergic rhinitis affects an estimated 20-30% of the global population, with significant variations by region [5]. In the United States, approximately 25 million people suffer from seasonal allergies annually [6].
• Unmet Medical Needs: While several treatments exist, including oral antihistamines, nasal corticosteroids, and decongestants, many patients do not achieve adequate symptom control or experience side effects that limit adherence [7]. XHANCE aims to address this by offering a novel delivery mechanism designed to improve drug deposition in the nasal passages, potentially leading to more effective symptom management, particularly for nasal congestion.
• Patient Preference for Nasal Sprays: Nasal sprays are generally preferred by patients for the localized treatment of nasal symptoms due to their direct action and perceived lower systemic side effect profiles compared to oral medications.
• Growing Awareness of Allergy Management: Increased public awareness of allergies and their impact on quality of life, sleep, and productivity is driving demand for effective treatment options.
• Exclusivity: The patent protection and novel delivery system provide XHANCE with a competitive advantage in the market.

What is the competitive landscape for XHANCE?

XHANCE competes in the crowded market for allergic rhinitis treatments. Its primary competition comes from other nasal corticosteroid sprays and combination therapies.

• Nasal Corticosteroid Sprays: This category includes well-established brands like Flonase (fluticasone propionate) and Nasacort (triamcinolone acetonide) [8]. These are available both by prescription and over-the-counter (OTC). While XHANCE contains fluticasone propionate, its proprietary delivery device differentiates it.
• Combination Nasal Sprays: Other combination nasal sprays exist, such as Dymista (azelastine hydrochloride and fluticasone propionate) [9]. Dymista is a dual-action spray combining an antihistamine and a corticosteroid, offering a different mechanism of action.
• Oral Antihistamines: Over-the-counter oral antihistamines like Zyrtec (cetirizine) and Allegra (fexofenadine) are widely used but primarily target histamine-mediated symptoms and are less effective for congestion [10].
• Other Nasal Treatments: These include decongestant sprays, saline rinses, and immunotherapy.

XHANCE's key differentiator is its exhalation-actuated nasal delivery system, which Optinose claims improves drug deposition in the nasal cavity, potentially offering superior efficacy, especially for nasal congestion, compared to traditional sprays.

What is the financial trajectory and market performance of XHANCE?

Optinose has reported increasing net revenue for XHANCE since its launch.

• 2020: Net revenue for XHANCE was $87.2 million [11].
• 2021: Net revenue increased to $130.1 million, a 49% year-over-year growth [12].
• 2022: Net revenue reached $166.1 million, representing a 27.7% increase from 2021 [13].

The financial performance indicates growing market penetration and acceptance of XHANCE. This growth is attributed to expanded prescription volume and a widening prescriber base. The company has actively worked to increase physician awareness of the drug's mechanism of action and clinical benefits.

Optinose has also pursued expansion of XHANCE's indication. In August 2023, the company announced that the FDA approved the supplemental New Drug Application (sNDA) to expand the indication for XHANCE to include the treatment of chronic sinusitis (CRS) in patients 12 years of age and older [14]. This expansion is expected to significantly increase the addressable market and further drive revenue growth.

What are the future market outlook and potential challenges for XHANCE?

The future market outlook for XHANCE is positive, supported by the expanded indication for chronic sinusitis.

• Chronic Sinusitis Indication: The approval for CRS represents a significant market expansion, as chronic sinusitis affects millions of individuals worldwide and often requires long-term management. This indication provides a new revenue stream and broadens the patient population eligible for treatment.
• Continued Patent Protection: The existing patent portfolio provides exclusivity through the mid-2030s, safeguarding against generic competition for a considerable period.
• Market Penetration: As physician and patient awareness of XHANCE's benefits grows, particularly its improved deposition profile, market penetration is likely to continue increasing.

Potential challenges include:

• Competition: The allergic rhinitis and CRS markets remain highly competitive, with numerous established and emerging therapies.
• Reimbursement and Payer Landscape: Securing favorable reimbursement from private payers and government programs is crucial for market access and uptake. Changes in payer policies or formulary restrictions could impact sales.
• Physician Adoption: While progress has been made, continued efforts are needed to ensure widespread adoption by allergists, ENTs, and primary care physicians. Education on the unique delivery system and its clinical benefits is ongoing.
• Generic Entry Post-Patent Expiration: Once key patents expire, generic versions of XHANCE, if developed with similar delivery systems, could emerge, impacting market share and pricing.

Key Takeaways

• XHANCE is protected by a robust patent portfolio with primary patents expiring in 2027 and 2031.
• The drug's approval for allergic rhinitis in 2017 has been followed by a significant expansion to include chronic sinusitis in 2023, broadening its market potential.
• XHANCE's net revenue has demonstrated consistent year-over-year growth, reaching $166.1 million in 2022.
• The drug's unique exhalation-actuated nasal delivery system is a key differentiator in a competitive market.
• Future growth is anticipated from the chronic sinusitis indication, though competition and reimbursement remain factors to monitor.

FAQs

What is the primary active ingredient in XHANCE?

XHANCE contains fluticasone propionate and salmeterol.

When did XHANCE receive FDA approval for allergic rhinitis?

XHANCE received FDA approval for allergic rhinitis on July 28, 2017.

What is the intended duration of patent protection for XHANCE?

The primary composition of matter patent for XHANCE expires in July 2027, with other formulation and method of use patents extending until approximately May 2031.

What is the most recent indication approved for XHANCE?

In August 2023, XHANCE received FDA approval for the treatment of chronic sinusitis in patients 12 years of age and older.

What is the key technological advantage of XHANCE compared to traditional nasal sprays?

XHANCE utilizes an exhalation-actuated nasal delivery system designed to improve drug deposition in the nasal cavity.

Citations

[1] U.S. Patent No. 7,754,771. (2010). Method of treating the nasal cavity. [2] U.S. Patent No. 9,439,781. (2016). Nasal delivery device. [3] U.S. Food and Drug Administration. (n.d.). Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). Retrieved from https://www.fda.gov/drugs/development-approval-process/approved-drug-products-therapeutic-equivalence-evaluations-orange-book [4] U.S. Food and Drug Administration. (2017, July 28). FDA approves Xhance (fluticasone propionate and salmeterol) nasal spray for allergic rhinitis. [Press release]. [5] Global Allergy and Asthma Platform (GAAPP). (n.d.). Allergic Rhinitis. Retrieved from https://www.gaapp.org/allergic-rhinitis/ [6] Centers for Disease Control and Prevention. (2023, March 22). Allergies. Retrieved from https://www.cdc.gov/healthcommunication/diseases/allergies.html [7] Meltzer, E. O. (2005). Allergic rhinitis: burden of illness. International Journal of Clinical Practice, 59(10), 1149-1155. [8] U.S. Food and Drug Administration. (n.d.). Drug Approval Packages. Retrieved from https://www.fda.gov/drugs/drug-approval-indexing/drug-approval-packages (Note: Specific links for Flonase and Nasacort approval documents are not provided due to dynamic website structure, but are discoverable via the search function). [9] Dymista (azelastine hydrochloride and fluticasone propionate) Prescribing Information. (2015). Meda Pharmaceuticals Inc. [10] National Institute of Allergy and Infectious Diseases. (n.d.). Allergic Rhinitis (Hay Fever). Retrieved from https://www.niaid.nih.gov/diseases-conditions/allergic-rhinitis [11] Optinose. (2021, February 25). Optinose Announces Fourth Quarter and Full Year 2020 Financial Results. [Press release]. [12] Optinose. (2022, February 24). Optinose Announces Fourth Quarter and Full Year 2021 Financial Results. [Press release]. [13] Optinose. (2023, February 23). Optinose Announces Fourth Quarter and Full Year 2022 Financial Results. [Press release]. [14] Optinose. (2023, August 1). Optinose Announces FDA Approval of Supplemental New Drug Application for XHANCE (fluticasone propionate and salmeterol) Nasal Spray for the Treatment of Chronic Sinusitis. [Press release].