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 ten 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. Five 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:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	92
Patent Applications:	2,252
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 ten 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
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
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/000527 Emend 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
Japan	2017533183	アプレピタントのエマルジョン製剤
China	106852118	阿瑞吡坦乳剂制剂 (Emulson formulations of aprepitant)
Japan	2022092040	アプレピタントのエマルジョン製剤
South Korea	102424837
Japan	2019196398	アプレピタントのエマルジョン製剤 (EMULSION FORMULATIONS OF APREPITANT)
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
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
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	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

CINVANTI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for CINVANTI

Introduction to CINVANTI

CINVANTI, developed by Heron Therapeutics, is an injectable emulsion of aprepitant, a substance P/neurokinin 1 (NK1) receptor antagonist. It is designed to prevent chemotherapy-induced nausea and vomiting (CINV), a common and debilitating side effect of chemotherapy.

Market Overview of CINV Drugs

The global market for CINV drugs is projected to grow significantly, driven by advances in medications and an increase in the number of patients undergoing chemotherapy. By 2031, the market is estimated to reach $4.3 billion, growing at a CAGR of 8.2%[4].

Geographical Market Share

North America and Europe currently hold the largest market shares due to the high incidence of cancer and the approval of new drugs. However, the Asia Pacific region is expected to offer substantial growth opportunities due to increasing market penetration by generic manufacturers[4].

Sales Performance of CINVANTI

Recent Financial Results

For the three and nine months ended September 30, 2024, CINVANTI saw notable sales growth. Net product sales for CINVANTI were $22.6 million and $73.2 million, respectively, compared to $23.3 million and $70.6 million for the same periods in 2023. Although the third-quarter sales were slightly lower than the previous year, the nine-month sales showed an increase[1][2].

Historical Context

In the fourth quarter and full year of 2023, CINVANTI sales continued to show positive momentum. For the three and twelve months ended December 31, 2023, net product sales were $24.3 million and $94.9 million, respectively, representing an increase from $23.1 million and $87.3 million in the corresponding periods of 2022[3].

Financial Trajectory

Revenue Growth

The revenue from CINVANTI has been a significant contributor to Heron Therapeutics' oncology care franchise. The oncology care franchise, which includes CINVANTI and SUSTOL, reported net product sales of $25.4 million and $83.8 million for the three and nine months ended September 30, 2024, respectively[1].

Operating Expenses and Profitability

While CINVANTI contributes substantially to the company's revenue, Heron Therapeutics still operates at a net loss. For the nine months ended September 30, 2024, the company reported a net loss of $17.2 million, despite narrowing its full-year 2024 guidance for product revenues and adjusted operating expenses[2].

Cost of Product Sales

The cost of product sales for Heron Therapeutics, including CINVANTI, was $9.4 million and $28.4 million for the three and nine months ended September 30, 2024, respectively. This reflects the ongoing investment in manufacturing and distribution[1][2].

Market Drivers

Increasing Chemotherapy Treatments

The rise in the number of patients undergoing chemotherapy is a key driver for the CINV market. As cancer incidence increases globally, the demand for effective CINV treatments like CINVANTI is expected to grow[4].

Advances in Medications

Recent advances in CINV medications, including the development of more effective agents with minimal side effects, have boosted the market. CINVANTI, with its injectable emulsion formulation, offers a convenient and effective treatment option[4].

Competitive Landscape

Market Competition

The CINV market is competitive, with several other drugs available. However, CINVANTI's unique formulation and efficacy profile help it maintain a significant market share. Heron Therapeutics continues to invest in research and development to stay competitive and expand its product portfolio[1][3].

Future Outlook

Growth Projections

Given the growing demand for CINV treatments and the positive sales trajectory of CINVANTI, Heron Therapeutics is well-positioned for future growth. The company's narrowed financial guidance for 2024 indicates a more focused approach to achieving profitability[2].

Emerging Markets

The Asia Pacific region presents significant growth opportunities for CINVANTI, driven by increasing market penetration and the need for effective CINV treatments. Heron Therapeutics may explore expansion into these markets to further boost sales[4].

Conclusion

CINVANTI is a critical component of Heron Therapeutics' oncology care franchise, contributing significantly to the company's revenue. Despite operating at a net loss, the positive sales growth and narrowing financial guidance suggest a promising financial trajectory. As the global CINV market continues to grow, CINVANTI is poised to remain a key player.

Key Takeaways

• Sales Growth: CINVANTI has shown consistent sales growth, with $22.6 million and $73.2 million in net product sales for the three and nine months ended September 30, 2024.
• Market Drivers: Increasing chemotherapy treatments and advances in medications drive the demand for CINVANTI.
• Financial Trajectory: Heron Therapeutics operates at a net loss but has narrowed its financial guidance, indicating a more focused approach to profitability.
• Competitive Landscape: CINVANTI competes in a competitive market but maintains a significant share due to its unique formulation and efficacy.
• Future Outlook: The Asia Pacific region offers substantial growth opportunities, and the company is well-positioned for future growth.

FAQs

What is CINVANTI used for?

CINVANTI is used to prevent chemotherapy-induced nausea and vomiting (CINV), a common side effect of chemotherapy.

How has CINVANTI performed in recent financial periods?

For the three and nine months ended September 30, 2024, CINVANTI's net product sales were $22.6 million and $73.2 million, respectively, showing a positive sales trajectory.

What are the key drivers of the CINV market?

The key drivers include the increasing number of patients undergoing chemotherapy and recent advances in CINV medications.

How competitive is the CINV market?

The CINV market is competitive, but CINVANTI's unique formulation and efficacy help it maintain a significant market share.

What are the future growth prospects for CINVANTI?

CINVANTI is poised for future growth, particularly in emerging markets like the Asia Pacific region, driven by increasing market penetration and demand for effective CINV treatments.

Sources

1. Heron Therapeutics Announces Third Quarter 2024 Financial Results - Heron Therapeutics IR.
2. Heron Therapeutics Announces Third Quarter 2024 Financial Results and Narrows Financial Guidance - PR Newswire.
3. Heron Therapeutics Announces Fourth Quarter and Full-Year 2023 Financial Results - Heron Therapeutics IR.
4. Global CINV Drugs Market $4.3 Billion by 2031 - iHealthcareAnalyst.