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
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for CINVANTI

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	9,808,465
Heron Theraps Inc	CINVANTI	aprepitant	EMULSION;INTRAVENOUS	209296-001	Nov 9, 2017		RX	Yes	Yes	9,974,793		Y
Heron Theraps Inc	CINVANTI	aprepitant	EMULSION;INTRAVENOUS	209296-001	Nov 9, 2017		RX	Yes	Yes	9,561,229		Y
Heron Theraps Inc	CINVANTI	aprepitant	EMULSION;INTRAVENOUS	209296-001	Nov 9, 2017		RX	Yes	Yes	10,500,208		Y
Heron Theraps Inc	CINVANTI	aprepitant	EMULSION;INTRAVENOUS	209296-001	Nov 9, 2017		RX	Yes	Yes	9,974,742		Y
Heron Theraps Inc	CINVANTI	aprepitant	EMULSION;INTRAVENOUS	209296-001	Nov 9, 2017		RX	Yes	Yes	10,953,018
Heron Theraps Inc	CINVANTI	aprepitant	EMULSION;INTRAVENOUS	209296-001	Nov 9, 2017		RX	Yes	Yes	9,974,794		Y

International Patents for CINVANTI

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2016044784
Japan	2017533183	アプレピタントのエマルジョン製剤
South Korea	102424837
Japan	6741655
Japan	6741655
Japan	2022092040	アプレピタントのエマルジョン製剤
World Intellectual Property Organization (WIPO)	2016044784

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,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
0748320	08C0019	France		PRODUCT NAME: FOSAPREPITANT DIMEGLUMINE; REGISTRATION NO/DATE: EU/1/07/437/001 20080111
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	04C0010	France		PRODUCT NAME: APREPITANT; REGISTRATION NO/DATE: EU/1/03/262/001 20031111
0748320	SPC/GB08/021	United Kingdom		PRODUCT NAME: FOSAPREPITANT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, IN PARTICULAR THE BIS(N-METHYL-D-GLUCAMINE)SALT; REGISTERED: UK EU/1/07/437/001 20080111; UK EU/1/07/437/002 20080111
0734381	SPC/GB04/011	United Kingdom		PRODUCT NAME: APREPITANT, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/03/262/001 20031113; UK EU/1/03/262/002 20031113; UK EU/1/03/262/003 20031113; UK EU/1/03/262/004 20031113; UK EU/1/03/262/005 20031113; UK EU/1/03/262/006 20031113

CINVANTI (aprepitant) Injection: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

---

Summary

CINVANTI (aprepitant), marketed by Heron Therapeutics, is an antiemetic indicated for preventing chemotherapy-induced nausea and vomiting (CINV). The drug's positioning within the antiemetic market, regulatory progress, competitive landscape, and growth potential shape its investment outlook. This analysis covers current market dynamics, revenue projections, regulatory environment, competitive forces, and strategic considerations to inform stakeholders and investors.

---

What Is the Current Market Position of CINVANTI?

Product Profile and Indications
CINVANTI is an intravenous formulation of aprepitant, a Substance P/neurokinin-1 (NK1) receptor antagonist, approved for:

• Prevention of acute and delayed chemotherapy-induced nausea and vomiting when combined with other antiemetics.

Key Differentiators:

Feature	Description
Formulation	IV, single-dose, rapid onset
Approval	U.S. FDA (October 2018), EMA (2019)
Indications	CINV in solid tumors, hematologic malignancies
Competitive Edges	Ease of use in infusion centers, combination with other drugs

Market Penetration and Revenues
In H1 2023, Heron reported revenues of approximately $28 million globally for CINVANTI, with a significant proportion derived from the U.S. market. Heron forecasts revenues between $70-$90 million by 2024, assuming increased uptake in oncology clinics.

---

What Are the Market Dynamics Influencing CINVANTI?

1. Size and Growth of the CINV Market

Market Size (2023):

• Global antiemetic market estimated at $3.8 billion (IQVIA, 2022).
• CINV segment represents roughly 40-45% of this, given the prevalence of chemotherapy for solid tumors and hematological malignancies.
• Estimated CINV-specific market: $1.7 billion.

Projected Growth (CAGR 2023-2030):

• Approximate 7-9%, driven by increasing cancer incidence and expanding chemotherapy protocols, especially in emerging markets.

2. Competitive Landscape

Competitors	Key Features	Market Share (2023)	Notes
Emend (aprepitant)	Oral and IV formulations	~35%	First-in-class NK1
Akynzeo (netupitant + palonosetron)	Combination oral	~25%	Convenient dosing
Generic aprepitant	Various formulations	~15%	Price-sensitive segment
Other antiemetics	Dopamine antagonists, corticosteroids	Remaining	Complementary, not direct competitors

Market Positioning:
Heron’s CINVANTI aims to capture steady growth through IV administration, especially in settings favoring rapid, single-dose regimens.

3. Regulatory and Reimbursement Environment

Aspect	Status	Implications
FDA Approval	2018	Validates safety and efficacy
CMS and Payer Reimbursements	Favorable in U.S.	Facilitates adoption in hospital and infusion centers
EMA Approval	2019	Expanding in Europe
Biosimilar and Generic Competition	Increasing	Pressure on prices, margins

4. Strategic Growth Drivers

• Expanding Oncology Treatments: New indications or line extensions could enlarge addressable market.
• Shift Toward IV Formulations: Patient preference for single-dose IV, especially in hospitals or infusion clinics, improves value proposition over oral drugs.
• Global Expansion: Emerging markets with rising cancer burden present opportunities, though regulatory pathways vary.

---

What Are the Key Investment and Revenue Trajectories?

Year	Revenue Estimate	Growth Rate	Assumptions
2023	$28 million	-	Base year
2024	$70–$90 million	150–220%	Increased adoption + market penetration
2025	$120–$150 million	40–66%	Market expansion and new indications
2026	$170–$210 million	30–40%	Mature market, higher penetration

Factors Influencing Revenue Growth:

• Adoption rate in U.S. hospital and infusion clinics (~20-25% in 2023, targeted to reach 50% by 2026).
• Entry into European markets post-approval.
• Potential licensing deals or partnership strategies.
• Competitive pricing strategies amid biosimilar entry.

Margins and Profitability:

• Heron’s gross margins are projected at 60-65%, given IV formulation costs.
• Operating margins will benefit from scale, with R&D focused on pipeline expansion.

---

How Do Competitive and Regulatory Factors Impact Investment Outlook?

Regulatory Environment

Region	Status	Challenges
U.S.	Approved (2018)	Payer negotiations
Europe	Approved (2019)	Market access
Emerging Markets	Pending or via partnership	Regulatory variability

Impact:
Easing access and reimbursement supports revenue growth; regulatory hurdles could delay expansion.

Pricing and Market Access Policies

• Price points hover around $500–$1,000 per dose in U.S. hospitals.
• Payer negotiations and formulary placements influence penetration.

Biosimilar and Generic Competition

• Several oral generic aprepitant products exist, pressuring prices.
• No IV biosimilar exists yet; patent expiry timelines for original compounds could influence future competition.

Strategic Risks and Opportunities

Risks	Opportunities
Patent challenges	Market exclusivity until at least 2030
Slow adoption	Increased effort in clinician education
Competition from oral formulations	IV offers unique clinical edge
Regulatory delays in emerging markets	Early market entry strategies

---

Comparison with Similar Oncology Anti-Nausea Drugs

Attribute	CINVANTI	Emend	Akynzeo
Administration	IV	Oral/IV	Oral
Time to Market	2018	2003	2014
Reimbursement	Favorable	Established	Favorable
Market Penetration (2023)	Moderate	Dominant	Growing
Regulatory Status	Approved in major markets	Approved since 2003	Approved in multiple markets

Distinctive Advantage:
CINVANTI’s IV, single-dose profile caters to institutional settings, differentiating it from the primarily oral competitors.

---

What Are the Main Investment Considerations?

Consideration	Analysis
Market Growth	Driven by rising cancer incidence; antiemetic needs expanding
Competitive Position	Unique IV formulation, clinical efficacy, and convenience
Revenue Potential	Significant upside with continued adoption; targeted $150 million+ by 2026
Regulatory Pathways	Favorable, with potential expansion; delays could impact timelines
Pricing Dynamics	Margin expansion possible; biosimilar threats looming
Pipeline Assets	Future indications could diversify revenue streams

---

Key Takeaways

• Rapid Growth Potential: CINVANTI is positioned for substantial revenue expansion, with projected revenues of $70–$90 million in 2024, increasing further as market adoption deepens.
• Market Expansion Opportunities: Supportive regulatory environment and the global rise in cancer treatments suggest promising upside, especially in Europe and emerging markets.
• Competitive Edges vs. Competition: The IV, single-dose administration provides clinical and operational advantages over oral formulations, although biosimilar competition may pressure margins.
• Strategic Risks: Market penetration hinges on payer acceptance, clinician adoption, and navigating biosimilar competition. Regulatory delays could constrain growth.
• Investment Outlook: Favorable, given the growing CINV market, Heron’s strategic positioning, and ongoing pipeline developments. Long-term value depends on continued market expansion, pipeline success, and competitive dynamics.

---

FAQs

1. What is the primary differentiation of CINVANTI compared to other antiemetics?

CINVANTI offers a single-dose IV formulation of aprepitant, enabling rapid administration and enhanced convenience in hospital and infusion center settings, compared to oral competitors.

2. How does the patent landscape impact CINVANTI's market exclusivity?

Heron holds composition and formulation patents until at least 2030, offering a period of market exclusivity. The absence of biosimilar versions for IV aprepitant further extends its competitive advantage.

3. What are the key revenue drivers for CINVANTI?

Major drivers include increased adoption in U.S. hospitals, expansion into European markets, and potential growth in emerging regions. Clinician preference for IV administration also favors uptake.

4. How does biosimilar competition influence CINVANTI's market prospects?

While oral generic aprepitant exerts price pressure, the IV formulation's clinical advantages provide a competitive moat. Nonetheless, biosimilars and generics may impact margins over time.

5. What strategic moves could enhance CINVANTI’s market share?

Heron’s focus on clinician education, expanding indications, strategic partnerships, and global expansion are key strategies to increase market penetration and revenue.

---

References

[1] IQVIA. (2022). Oncology Market Insights.
[2] Heron Therapeutics Investor Presentation. (Q2 2023).
[3] FDA Label for CINVANTI (aprepitant) Injection. (2018).
[4] European Medicines Agency (EMA). Approval documentation, 2019.