CINVANTI Drug Patent Profile

Which patents cover Cinvanti, and what generic alternatives are available?

Cinvanti is a drug marketed by Heron Theraps Inc and is included in one NDA. There are thirteen patents protecting this drug and one Paragraph IV challenge.

This drug has nine patent family members in five countries.

The generic ingredient in CINVANTI is aprepitant. There are twenty-six drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the aprepitant profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Cinvanti

A generic version of CINVANTI was approved as aprepitant by SANDOZ on September 24^th, 2012.

Summary for CINVANTI

International Patents:	9
US Patents:	13
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	87
Patent Applications:	3,349
Drug Prices:	Drug price information for CINVANTI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CINVANTI
What excipients (inactive ingredients) are in CINVANTI?	CINVANTI excipients list
DailyMed Link:	CINVANTI at DailyMed

See drug prices for CINVANTI

Pharmacology for CINVANTI

Drug Class	Substance P/Neurokinin-1 Receptor Antagonist
Mechanism of Action	Cytochrome P450 2C9 Inducers Cytochrome P450 3A4 Inducers Cytochrome P450 3A4 Inhibitors Neurokinin 1 Antagonists

Paragraph IV (Patent) Challenges for CINVANTI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CINVANTI	Intravenous Emulsion	aprepitant	130 mg/18 mL	209296	1	2022-04-29

US Patents and Regulatory Information for CINVANTI

CINVANTI 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
Heron Theraps Inc	CINVANTI	aprepitant	EMULSION;INTRAVENOUS	209296-001	Nov 9, 2017		RX	Yes	Yes
Heron Theraps Inc	CINVANTI	aprepitant	EMULSION;INTRAVENOUS	209296-001	Nov 9, 2017		RX	Yes	Yes			Y
Heron Theraps Inc	CINVANTI	aprepitant	EMULSION;INTRAVENOUS	209296-001	Nov 9, 2017		RX	Yes	Yes			Y

EU/EMA Drug Approvals for CINVANTI

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merck Sharp & Dohme B.V.	Emend	aprepitant	EMEA/H/C/000527Emend 40 mg hard capsules is indicated for the prevention of postoperative nausea and vomiting (PONV) in adults.Emend is also available as 80 mg and 125 mg hard capsules for the prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in adults and adolescents from the age of 12 (see separate Summary of Product Characteristics).Emend is also available as 165 mg hard capsules for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin based cancer chemotherapy in adults and the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults.Emend is also available as powder for oral suspension for the prevention of nausea and vomiting associated with highly and moderately emetogenic cancer chemotherapy in children, toddlers and infants from the age of 6 months to less than 12 years.Emend 80 mg, 125 mg, 165 mg hard capsules and Emend powder for oral suspension are given as part of combination therapy.	Authorised	no	no	no	2003-11-11

International Patents for CINVANTI

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

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3193830	FORMULATIONS D'ÉMULSON D'APRÉPITANT (EMULSON FORMULATIONS OF APREPITANT)
Japan	2017533183	アプレピタントのエマルジョン製剤
China	106852118

Supplementary Protection Certificates for CINVANTI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0734381	3/2004	Austria		PRODUCT NAME: APREPITANT, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEMBAREN SALZES; REGISTRATION NO/DATE: EU/1/03/262/001 - EU/1/03/262/006 20031111
0734381	PA2004002	Lithuania		PRODCUT NAME: 5-[[(2R,3S)-2-[(1R)-1-[3,5-BIS(TRIFLUORMETIL)FENIL]ETOKSI]-3-(4-FLUORFENIL)-4-MORFOLINIL]METIL]-1,2-DIHIDRO-3H-1,2,4-TRIAZOL-3-ONAS (APREPITANTAS); REGISTRATION NO./DATE: EU/1/03/262/001-006/20031111
0734381	PA2004002,C0734381	Lithuania		PRODUCT NAME: 5-(((2R,3S)-2-((1R)-1-(3,5-BIS(TRIFLUORMETIL)FENIL)ETOKSI)-3-(4-FLUORFENIL)-4-MORFOLINIL)METIL)-1,2-DIHIDRO-3H-1,2,4-TRIAZOL-3-ONAS (APREPITANTAS); REGISTRATION NO/DATE: EU/1/03/262/001, 2003 11 11, EU/1/03/262/002, 2003 11 11, EU/1/03/262/003, 2003 11 11, EU/1/03/262/004, 2003 11 11, EU/1/03/262/005, 2003 11 11, EU/1/03/262/006 20031111

Market Dynamics and Financial Trajectory for CINVANTI (Fosnetupitant) in the Anti-Nausea Therapeutics Sector

Last updated: July 27, 2025

Introduction

CINVANTI (fosnetupitant), marketed by Heron Therapeutics, Inc., is a pioneering antiemetic primarily used for the prevention of chemotherapy-induced nausea and vomiting (CINV). Approved by the U.S. FDA in 2018, CINVANTI represents a significant advancement in supportive cancer care, offering extended efficacy through a single intravenous (IV) dose. Its market trajectory is influenced by evolving clinical practices, competitive landscape, reimbursement policies, and pipeline developments. This analysis delineates the market dynamics and projects its financial outlook.

Market Overview and Therapeutic Context

The global antiemetics market, valued at approximately USD 3.75 billion in 2022, is driven by increasing cancer incidence, evolving chemotherapy protocols, and heightened awareness of supportive care. Among antiemetics, neurokinin-1 (NK-1) receptor antagonists like fosnetupitant form a critical component of anti-CINV regimens, particularly for highly emetogenic chemotherapy (HEC) and moderately emetogenic chemotherapy (MEC).

CINVANTI’s unique offering is its IV formulation, enabling single-dose administration—an advantage over oral formulations requiring multiple doses. This positions the drug favorably within inpatient oncology settings, particularly for chemotherapy cycles with high emetic potential.

Market Dynamics Influencing CINVANTI

1. Growing Adoption in Oncology Protocols

The pharmacological profile of CINVANTI—offering 120-hour antiemetic coverage—aligns with updated clinical guidelines from the Multinational Association of Supportive Care in Cancer (MASCC) and the American Society of Clinical Oncology (ASCO). These guidelines recommend NK-1 receptor antagonists as standard components in antiemetic regimens for HEC, fostering increased adoption.

Hospitals and clinics favor IV formulations for their convenience and compliance benefits, especially for patients undergoing outpatient or inpatient chemotherapy. Heron Therapeutics has increasingly targeted hospital formularies and infusion centers, promoting its integration into standard protocols.

2. Competitive Landscape and Differentiation

CINVANTI competes primarily with branded NK-1 antagonists such as Merck's Emend (fosaprepitant) and generic aprepitant, as well as with other combination therapies incorporating 5-HT3 antagonists and corticosteroids. While emend offers an oral formulation that requires multiple doses, CINVANTI’s single IV dose offers logistical advantages.

However, competitive pricing, patent protections, and emerging biosimilars impact market share. The expiration of patents for some competitors could contextualize CINVANTI’s growth, but the drug's differentiation in dosing and efficacy sustains its position.

3. Reimbursement and Healthcare Policy

Reimbursement policies significantly influence market penetration. CINVANTI’s coverage under Medicare and private insurance has improved as evidence of its clinical utility has accumulated. Cost-effectiveness analyses favor CINVANTI’s single-dose administration, reducing administration time and resource utilization, thereby incentivizing payers to include it.

Furthermore, hospital procurement strategies and formulary negotiations significantly impact access, with Heron Therapeutics securing preferential positioning in major oncology centers.

4. Pipeline Development and Regulatory Opportunities

Heron Therapeutics is exploring additional formulations and combination therapies, including oral formulations, which could extend the drug’s reach to outpatient settings and broaden its adoption.

Regulatory pathways in other jurisdictions, such as Europe and Asia, could expand access and revenue streams. The company’s pursuit of supplemental approvals and expanded indications remains pivotal.

Financial Trajectory Analysis

1. Revenue Trends and Market Penetration

Since its launch, CINVANTI’s sales have demonstrated steady growth, albeit from a modest base due to the specialized niche. In 2022, Heron Therapeutics reported drug revenues of approximately USD 70 million, with CINVANTI contributing a significant share, driven by increased hospital adoption and expanded indications.

Projected CAGR (Compound Annual Growth Rate) for CINVANTI revenues is estimated at 12-15% over the next five years, fueled by rising chemotherapy protocols requiring robust antiemetics, and the drug’s unique dosing advantage.

2. Commercial Expansion Opportunities

Heron Therapeutics aims to penetrate outpatient clinics and oncology practices beyond hospital settings, leveraging their solidified presence in inpatient therapies. The development of oral formulations and fixed-dose combinations could further accelerate revenue growth, capturing broader patient populations.

Investments in direct-to-consumer marketing and physician education are expected to augment prescribing rates.

3. Cost Management and Pricing Dynamics

Pricing strategies will remain pivotal. While premium pricing is justified by the clinical benefits, competitive pressures and healthcare cost containment measures could temper revenue growth. Payer discounts, rebates, and contracting are likely to modulate gross margins, necessitating efficiency in sales and marketing expenditures.

4. Risks and Mitigation Strategies

Key risks include patent challenges, emerging biosimilars, and the potential for pipeline competition. Strategic investments in pipeline diversification and geographic expansion are crucial to mitigate these risks, alongside proactive patent litigations and licensing negotiations.

Future Outlook and Strategic Recommendations

Heron Therapeutics’ strategic focus should encompass expanding indications, optimizing formulary access, and innovating delivery mechanisms. Collaborations with healthcare providers and payers, alongside regulatory efforts in targeted geographies, will be instrumental in enhancing market share and revenue streams.

The ongoing clinical trials evaluating CINVANTI in combination with other therapeutics and in different lines of therapy can unlock additional revenue avenues. A proactive approach to digital health integration and patient-centric delivery models will further enhance adoption.

Key Takeaways

• CINVANTI’s market growth is underpinned by clinical guideline endorsement, hospital-centric use, and logistical advantages of IV dosing.
• Competitiveness hinges on differentiation through efficacy, dosing convenience, and reimbursement strategy alignment.
• Expanding access via pipeline innovations, geographical expansion, and outpatient adoption remains critical for sustained financial growth.
• Revenue projections indicate a CAGR of approximately 12-15% over the next five years, contingent on market uptake and competitive dynamics.
• Mitigating patent risks and fostering pipeline development will be vital to maintaining market dominance.

FAQs

1. How does CINVANTI compare to other NK-1 receptor antagonists?
CINVANTI offers a single IV dose with extended 120-hour coverage, providing logistical and compliance advantages over oral alternatives like aprepitant, which require multiple doses over several days.

2. What are the primary drivers for CINVANTI’s growth?
Increased adoption in HEC regimens, hospital formulary placements, guideline endorsements, and the drive toward outpatient chemotherapy support growth.

3. What challenges could hinder CINVANTI’s market expansion?
Generic competition, pricing pressure, patent litigations, and the emergence of new antiemetic therapies could limit growth.

4. How does reimbursement influence CINVANTI’s sales?
Strong reimbursement policies facilitate formulary access, but price negotiations and payer caps can impact overall revenues.

5. What is the expected timeline for pipeline developments to impact revenues?
New formulations and expanded indications are projected for approval within the next 2-4 years, with revenue contributions expected shortly thereafter.

---

Sources:

[1] MarketWatch, "Global Anti-Emetics Market Size & Growth Analysis," 2022.
[2] Heron Therapeutics, FY2022 Financial Statements.
[3] Clinical Practice Guidelines, MASCC and ASCO, 2020.
[4] IQVIA, "Pharmaceutical Market Data," 2022.
[5] Company Press Releases and Regulatory Filings.