SINUVA Drug Patent Profile

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

Sinuva is a drug marketed by Intersect Ent Inc and is included in one NDA. There are thirteen patents protecting this drug.

This drug has forty-seven patent family members in twelve countries.

The generic ingredient in SINUVA is mometasone furoate. There are thirty drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the mometasone furoate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Sinuva

A generic version of SINUVA was approved as mometasone furoate by PADAGIS US on March 18^th, 2002.

Summary for SINUVA

International Patents:	47
US Patents:	13
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	80
Patent Applications:	4,474
Drug Prices:	Drug price information for SINUVA
What excipients (inactive ingredients) are in SINUVA?	SINUVA excipients list
DailyMed Link:	SINUVA at DailyMed

See drug prices for SINUVA

Pharmacology for SINUVA

Drug Class	Corticosteroid
Mechanism of Action	Corticosteroid Hormone Receptor Agonists

US Patents and Regulatory Information for SINUVA

SINUVA is protected by thirteen US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017		RX	Yes	No	8,109,918
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017		RX	Yes	No	10,357,640
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017		RX	Yes	No	8,025,635		Y
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017		RX	Yes	No	10,406,332		Y
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017		RX	Yes	No	7,662,141
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017		RX	Yes	No	7,951,131

Expired US Patents for SINUVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017	7,662,141
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017	8,109,918
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017	7,951,133
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017	7,951,131
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017	7,713,255
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017	7,951,130

International Patents for SINUVA

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2010014834
Canada	2903848	SYSTEMES, DISPOSITIFS ET METHODE DE TRAITEMENT D'UNE AFFECTION SINUSALE (SYSTEMS, DEVICES, AND METHOD FOR TREATING A SINUS CONDITION)
South Korea	20080005939	DEVICE AND METHODS FOR TREATING PARANASAL SINUS CONDITIONS
Hong Kong	1201125	可展開裝置 (EXPANDABLE DEVICES)
European Patent Office	2320832	PROCÉDÉS ET DISPOSITIFS POUR SERTIR DES DISPOSITIFS AUTO-DILATABLES (METHODS AND DEVICES FOR CRIMPING SELF-EXPANDING DEVICES)
China	105188831	Systems, devices, and methods for treating a sinus condition

Supplementary Protection Certificates for SINUVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3043773	21C1057	France		PRODUCT NAME: MOMETASONE OU L'UN DE SES SELS AVEC OLOPATADINE OU L'UN DE SES SELS; NAT. REGISTRATION NO/DATE: NL52121 20211026; FIRST REGISTRATION: AT - 140638 20210426
3043773	SPC/GB21/077	United Kingdom		PRODUCT NAME: MOMETASONE OR A SALT THEREOF AND OLOPATADINE OR A SALT THEREOF; REGISTERED: AT 140638 20210426; UK PL 25258/0331 - 0001 20210511
3043773	2190041-0	Sweden		PRODUCT NAME: MOMETASONE OR A SALT THEREOF AND OLOPATADINE OR A SALT THEREOF; NAT. REG. NO/DATE: MT NR 60226 20210519; FIRST REG.: AT APPROVAL NR 140638 20210426
0548114	SPC/GB97/064	United Kingdom		PRODUCT NAME: MOMETASONE FUROATE MONOHYDRATE; REGISTERED: FR AMM 343012.6 19970219; UK 00201/0216 19970410
3043773	2022C/520	Belgium		PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203
0112669	96C0002	Belgium		PRODUCT NAME: MOMETASONE FUROATE; NAT. REGISTRATION NO/DATE: NL 19601 19950919; FIRST REGISTRATION: GR - 10681/89 19900622

SINUVA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SINUVA

Introduction to SINUVA

SINUVA is a sinus implant developed by Intersect ENT, designed to treat nasal polyps in patients who have undergone previous ethmoid sinus surgery. The implant releases the corticosteroid mometasone furoate, which helps reduce inflammation and the size of nasal polyps.

Market Position and Dominance

Intersect ENT holds a significant market position with its SINUVA implant, particularly in the drug-eluting stent market. The company's monopoly in this niche allows it to maintain higher selling prices, contributing to the market's growth. The global drug-eluting stent market, which includes SINUVA, was valued at $105.6 million in 2022 and is projected to grow at a CAGR of 1.8% to reach $119.6 million by 2029[1].

Revenue and Growth

The financial performance of Intersect ENT, particularly driven by SINUVA and the Propel family of products, has shown notable growth. In 2018, total revenue grew to $108.5 million, up 13% from $96.3 million in 2017. SINUVA contributed 3% of the revenue, or $2.8 million, in its initial year of commercialization[2].

In the second quarter of 2021, Intersect ENT reported a significant increase in revenue, partly due to the strong performance of SINUVA. The revenue for the second quarter of 2021 was $27.3 million, a 180% increase compared to $9.8 million in the second quarter of 2020. This surge was largely attributed to the record quarterly sales of SINUVA[5].

Gross Profit and Margin

The gross profit and margin for Intersect ENT have been influenced by the introduction and sales of SINUVA. In 2018, the gross profit was $85.9 million with a gross margin of 79%, slightly lower than the 84% in 2017 due to increased overhead and inefficiencies associated with the commercialization of SINUVA[2].

For the second quarter of 2021, the gross profit was $19.0 million, with a gross margin of 69.5%, indicating a significant improvement from the 24.8% in the same period of 2020. This improvement reflects the positive impact of SINUVA on the company's financials[5].

Operating Expenses

The operating expenses for Intersect ENT have increased with the expansion of SINUVA commercial and market access activities. In 2018, operating expenses rose to $110.9 million, a 13% increase from $98.4 million in 2017. This increase was driven by higher headcount, marketing, and consulting expenses related to SINUVA's commercialization[2].

For the second quarter of 2021, operating expenses were $35.1 million, with selling, general, and administrative (SG&A) expenses and research and development (R&D) expenses contributing significantly to this total. The SG&A expenses increased to $28.7 million, and R&D expenses rose to $6.4 million, reflecting ongoing investments in SINUVA and other products[5].

Market Drivers and Barriers

Market Drivers:

• Monopoly in the Market: Intersect ENT's dominance in the drug-eluting stent market, including SINUVA, allows for higher selling prices and contributes to market growth[1].
• Increasing Adoption: The growing adoption of SINUVA and other steroid-releasing implants has driven revenue growth for Intersect ENT[2].
• Clinical Efficacy: The effectiveness of SINUVA in reducing nasal polyps and alleviating symptoms has been a key driver of its market success.

Market Barriers:

• Regulatory Challenges: Any changes in regulatory environments or approval processes can impact the market trajectory of SINUVA.
• Competition from Emerging Therapies: The introduction of new biologic therapies for nasal polyps, such as Fasenra and Tezepelumab, could potentially reduce the demand for surgical interventions like SINUVA[4].

Competitive Landscape

Intersect ENT faces competition from other companies involved in nasal polyps treatment, although it remains the sole competitor in the drug-eluting stent market for sinus implants. Key players in the broader nasal polyps treatment market include GlaxoSmithKline, Optinose US Inc., Sanofi, Regeneron Pharmaceuticals, and AstraZeneca, among others[4].

Future Outlook

The future outlook for SINUVA is positive, given its established market presence and the growing demand for effective treatments for nasal polyps. As the global sinus therapeutic drug market grows at a CAGR of 3.7% from 2024 to 2033, SINUVA is likely to continue contributing significantly to Intersect ENT's revenue and market share[3].

Key Takeaways

• Market Dominance: Intersect ENT's monopoly in the drug-eluting stent market drives higher selling prices and market growth.
• Revenue Growth: SINUVA has contributed significantly to Intersect ENT's revenue growth, particularly in recent quarters.
• Gross Profit and Margin: The introduction of SINUVA has impacted gross profit and margin, with improvements seen in recent periods.
• Operating Expenses: Increased expenses related to SINUVA's commercialization have been a factor in overall operating costs.
• Market Drivers and Barriers: Monopoly, increasing adoption, and clinical efficacy drive the market, while regulatory challenges and emerging therapies pose potential barriers.

FAQs

1. What is SINUVA used for? SINUVA is a sinus implant used to treat nasal polyps in patients who have undergone previous ethmoid sinus surgery.

2. Who is the primary manufacturer of SINUVA? Intersect ENT is the primary manufacturer of SINUVA.

3. What is the projected market size for the global drug-eluting stent market by 2029? The global drug-eluting stent market is projected to reach $119.6 million by 2029, growing at a CAGR of 1.8% from 2022[1].

4. How has SINUVA impacted Intersect ENT's revenue? SINUVA has significantly contributed to Intersect ENT's revenue growth, with notable increases in recent quarters, such as a 180% increase in the second quarter of 2021 compared to the same period in 2020[5].

5. What are the potential market barriers for SINUVA? Potential market barriers include regulatory challenges and the emergence of new biologic therapies for nasal polyps, which could reduce the demand for surgical interventions like SINUVA[4].

Cited Sources:

1. ResearchAndMarkets.com, "Global Drug-Eluting Stent Market Size, Share, & COVID-19 Impact Analysis 2023-2029 - MedCore"[1].
2. Biospace, "Intersect ENT Reports Fourth Quarter and Full Year 2018 Results"[2].
3. Market.us, "Sinus Therapeutic Drug Market Segment, Market | CAGR of 3.7%"[3].
4. PR Newswire, "The Nasal Polyposis Treatment Market Size is Anticipated to Increase at a Significant CAGR of 9 in the 7MM as per DelveInsight"[4].
5. Business Wire, "Intersect ENT Reports Second Quarter 2021 Financial Results"[5].