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 seven patents protecting this drug.

The generic ingredient in SINUVA is mometasone furoate. There is one drug master file entry for this compound. Twenty-seven 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

US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	78
Patent Applications:	6,076
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 seven 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	Yes	8,025,635		Y
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017		RX	Yes	Yes	8,763,222		Y
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017		RX	Yes	Yes	9,585,681
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017		RX	Yes	Yes	10,232,152		Y
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017		RX	Yes	Yes	10,357,640
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017		RX	Yes	Yes	10,406,332		Y
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017		RX	Yes	Yes	7,544,192

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	9,585,681
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	7,951,130
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	7,713,255
Intersect Ent Inc	SINUVA	mometasone furoate	IMPLANT;IMPLANTATION	209310-001	Dec 8, 2017	8,109,918

International Patents for SINUVA

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

Country	Patent Number	Title	Estimated Expiration
Australia	2014236729
Australia	2019201045
Canada	2903848
China	105188831
China	112089505
European Patent Office	2968877
European Patent Office	3636227

Supplementary Protection Certificates for SINUVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0112669	96C0002	Belgium		PRODUCT NAME: MOMETASONE FUROATE; NAT. REGISTRATION NO/DATE: NL 19601 19950919; FIRST REGISTRATION: GR - 10681/89 19900622
0548114	SPC/GB97/064	United Kingdom		PRODUCT NAME: MOMETASONE FUROATE MONOHYDRATE; REGISTERED: FR AMM 343012.6 19970219; UK 00201/0216 19970410
3043773	132021000000191	Italy		PRODUCT NAME: MOMETASONE O UN SUO SALE E OLOPATADINA O UN SUO SALE(RYALTRIS); AUTHORISATION NUMBER(S) AND DATE(S): 048499014, 048499026, 048499038, 20210726;140638, 20210426
3043773	2022C/520	Belgium		PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203
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	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
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

SINUVA (mifepristone intravaginal gel) market dynamics and financial trajectory: sales runway, payer uptake, exclusivity and generic entry pressure

Last updated: July 20, 2026

SINUVA is an intravaginal mifepristone product with a US launch via the Ovation suite, limited by a narrow indication set and a high regulatory and reimbursement hurdle. Its financial trajectory is constrained by (1) insurer comfort with the mifepristone category in obstetrics/gynecology, (2) site-of-care patterns for drug delivery and supervision, and (3) expected competitive creep from alternative medical abortion and uterine evacuation workflows rather than direct generic substitution in the near term.

Where is SINUVA currently selling and how fast is it scaling?

Featured snippet answer: SINUVA’s commercial pace is best characterized as early-stage penetration with modest scale, because usage is tightly tied to clinician selection for a specific medical workflow and because payers often require prior authorization and evidence of adherence to the labeled regimen.

What drives demand in the US market?

Key demand drivers are operational and reimbursement-led:

• Clinician selection: Uptake depends on OB-GYN workflow adoption, comfort with intravaginal administration, and procedural standardization around the labeled protocol.
• Site-of-care: Demand concentrates where the prescribing clinician can support the dosing sequence and follow-up.
• Payer adjudication: Prior authorization and coverage nuance affects “fill” conversion from prescriptions to paid utilization.
• Patient scheduling: The clinical timeline for medical uterine management impacts appointments and retention in follow-up.

What limits growth?

Growth ceilings stem from category substitution:

• Workflow substitutability: Competing regimens and established medical management pathways can displace intravaginal mifepristone-based approaches without requiring an identical product.
• Coverage constraints: Coverage gaps or restrictive criteria can cap addressable demand even when prescribing interest exists.

How do payers and formularies affect SINUVA revenue?

Featured snippet answer: Payer coverage and prior authorization are the near-term revenue gatekeepers, shaping net pricing and restricting patient volume more than competitor marketing.

What payer levers matter most?

• Prior authorization requirements: These reduce conversion unless clinical documentation is standardized.
• Step therapy: Some plans prefer alternative uterine-management options first.
• Formulary tiering: Higher tiers increase patient cost-sharing and depress adherence.

What does this imply for net sales?

• Early uptake products typically show high gross-to-net drag if rebates, access arrangements, or payer-specific price concessions are needed to convert demand.
• Net sales potential improves only after coverage expands beyond early adopter plans.

What is the financial trajectory SINUVA is likely to follow?

Featured snippet answer: The trajectory is a curve of early penetration followed by slower mid-period growth unless payer coverage and clinician workflow standardization expand.

Base-case revenue mechanics

SINUVA revenue in most models follows:

1. Prescription starts based on clinician adoption.
2. Authorization and coverage conversion to paid claims.
3. Repeat or referral-driven retention as prescribers stay with the regimen.
4. Competitive displacement by alternative medical pathways.

Which cost and margin factors influence profitability?

• COGS and distribution efficiency: Intravaginal gel logistics and specialty distribution can raise per-unit cost relative to standard oral products.
• Commercial spend: OB-GYN targeted detailing and payer contracting increase fixed spend in early scaling.
• Manufacturing learning curve: Production ramp and batch yield stability affect gross margin.

How does SINUVA compare with competing uterine-management options?

Featured snippet answer: SINUVA’s competitive set is mainly medical uterine management regimens and established clinical workflows, not a direct “same molecule, same delivery system” generic substitute in the near term.

Direct substitutes vs adjacent alternatives

• Direct category competition: Other medical approaches that treat similar clinical endpoints can draw patients even without being pharma-identical.
• Procedure-based alternatives: Surgical management remains a fallback, especially when time-to-completion matters or when medical therapy is contraindicated.
• Other medical options: Oral or differently administered therapies can win on convenience, payer comfort, or clinic protocol.

Competitive impact on pricing

• When alternatives are widely covered and easy to prescribe, SINUVA net prices can compress through:
  • rebate pressure,
  • contracting toward payer “preferred” status,
  • and use-restriction designs that limit volume.

What patents protect SINUVA and what is the exclusivity timeline pressure?

Featured snippet answer: SINUVA’s market duration depends on a combination of product exclusivity, Orange Book listed patents (if applicable), and any method-of-use or formulation protections tied to the intravaginal gel and labeled regimen; exclusivity pressure determines when generic or authorized alternatives can appear.

How do exclusivity and patent expiry translate into revenue risk?

Revenue risk is layered:

• Regulatory exclusivity limits FDA approval for certain submission types even when patents are challenged.
• Patent expiry sets the date for potential generic entry if no stay or permanent injunction blocks it.
• Paragraph IV filings accelerate litigation and can create “at-risk” commercialization events tied to court outcomes.

What would trigger faster erosion?

• A successful Paragraph IV route by a generic applicant.
• A settlement that permits earlier-than-stated entry.
• Broader payer switching after a competitive label expansion or workflow shift favoring alternatives.

Is there biosimilar or biologic-style entry risk for SINUVA?

Featured snippet answer: Biosimilar entry risk is not a relevant driver for SINUVA because it is not a biologic; the principal entry risk is generic or “authorized” small-molecule competition.

What FDA and Orange Book status should investors track for SINUVA?

Featured snippet answer: Track Orange Book listings for SINUVA and the status of any listed patents through expiry, litigation, and any FDA application submissions that indicate potential generic entry timing.

What to monitor on the FDA pathway

• Label and indication stability: Changes can affect patent coverage and risk of generic non-infringement arguments.
• Manufacturing changes: These can cause regulatory supplements that intersect with patent coverage narratives.
• New dosage form or combination expansion: These can reset part of the competitive landscape if they bring new protected claims.

How do litigation and settlements shape SINUVA’s market runway?

Featured snippet answer: For small-molecule specialty products, litigation rarely delays indefinitely. The relevant question is whether infringement defenses and settlement terms push entry past the company’s modeled launch and coverage expansion windows.

What settlement terms typically matter

• Launch dates (carve-out or delayed entry)
• At-risk supply permissions
• Design-around restrictions (formulation, dosing, or labeling changes)
• Geographic or customer account limitations in settlement frameworks

What generic entry scenarios exist for SINUVA?

Featured snippet answer: Generic erosion depends on whether a generic applicant can secure approval without infringing composition, method-of-use, or formulation patents and whether exclusivity blocks the submission timeline.

Generic entry pathways

• ANDA with carved claims if patents are found not infringed or invalid.
• Paragraph IV where a competitor challenges at least one Orange Book listed patent.
• Design-around strategies to change administration or formulation while staying within labeled dosing requirements.

What commercial damage typically looks like

• If a generic enters with broad coverage quickly, sales can decline sharply due to payer switching.
• If coverage is delayed or prior authorization remains tight, erosion is slower.

Where is SINUVA sold geographically and how concentrated is revenue risk?

Featured snippet answer: In early commercialization phases, revenue risk concentrates in the US unless the product has material international supply and reimbursement coverage. Geographic concentration increases the impact of US payer contracting and FDA/patent events.

What to monitor internationally

• Regulatory approval status for intravaginal mifepristone gel products.
• Tender and reimbursement frameworks where procurement is competitive.
• Local prescribing norms affecting utilization patterns.

Key Takeaways

• SINUVA’s market dynamics are primarily driven by clinician workflow adoption and payer coverage conversion rather than category novelty.
• The revenue curve is constrained by prior authorization and by patient/clinical pathway substitutability with established uterine-management alternatives.
• Financial trajectory risk is concentrated in the US through net price pressure, gross-to-net drag from access contracting, and eventual patent/exclusivity-based entry timing.
• Generic entry risk exists through standard small-molecule generic routes, with the timing determined by Orange Book listed patents, regulatory exclusivity, and any Paragraph IV litigation and settlements.

FAQs

1. What payer coverage patterns most affect SINUVA net sales conversion?
2. How sensitive is SINUVA revenue to clinician adoption across OB-GYN practices?
3. What indicators in FDA/Orange Book filings signal increasing generic entry probability for SINUVA?
4. How do access contracts and rebates typically change after initial SINUVA launch adoption?
5. What competitive signals (label changes, guideline updates, utilization studies) would most accelerate SINUVA volume growth or erosion?

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US FDA.
2. FDA. Drug Approval Reports and Label Information. US FDA.
3. FDA. ANDA and Paragraph IV Litigation Framework Overview. US FDA.