APONVIE Drug Patent Profile

When do Aponvie patents expire, and when can generic versions of Aponvie launch?

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

This drug has nine patent family members in five countries.

The generic ingredient in APONVIE 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 Aponvie

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

Summary for APONVIE

International Patents:	9
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	92
Patent Applications:	2,256
Drug Prices:	Drug price information for APONVIE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for APONVIE
What excipients (inactive ingredients) are in APONVIE?	APONVIE excipients list
DailyMed Link:	APONVIE at DailyMed

See drug prices for APONVIE

Pharmacology for APONVIE

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 APONVIE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
APONVIE	Intravenous Emulsion	aprepitant	32 mg/4.4 mL	216457	1	2023-11-07

US Patents and Regulatory Information for APONVIE

APONVIE is protected by eleven 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	APONVIE	aprepitant	EMULSION;INTRAVENOUS	216457-001	Sep 16, 2022		RX	Yes	Yes
Heron Theraps Inc	APONVIE	aprepitant	EMULSION;INTRAVENOUS	216457-001	Sep 16, 2022		RX	Yes	Yes
Heron Theraps Inc	APONVIE	aprepitant	EMULSION;INTRAVENOUS	216457-001	Sep 16, 2022		RX	Yes	Yes

EU/EMA Drug Approvals for APONVIE

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 APONVIE

See the table below for patents covering APONVIE 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
South Korea	20170056575	아프레피탄트의 에멀젼 제형 (EMULSION FORMULATIONS OF APREPITANT)
Japan	2022092040	アプレピタントのエマルジョン製剤

Supplementary Protection Certificates for APONVIE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0748320	08C0019	France		PRODUCT NAME: FOSAPREPITANT DIMEGLUMINE; REGISTRATION NO/DATE: EU/1/07/437/001 20080111
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

APONVIE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for APONVIE

Introduction to APONVIE

APONVIE, developed by Heron Therapeutics, is a substance P/neurokinin 1 (NK1) receptor antagonist indicated for the prevention of postoperative nausea and vomiting (PONV) in adults. It is administered via a 30-second intravenous (IV) push, offering a rapid onset of action and a safety profile comparable to ondansetron without the risk of QT prolongation[4].

Market Opportunity for PONV Prevention

The market for PONV prevention is substantial, with approximately 36 million annual procedures involving patients at moderate to high risk for PONV. Of these, around 17 million patients are at high risk and 19 million at moderate risk, with about 12 million high to moderate risk patients currently not receiving prophylaxis[1].

Target Market and Patient Segmentation

The target market for APONVIE is segmented based on the Apfel risk score, which categorizes patients into low, moderate, and high risk for PONV. The key risk factors include female gender, non-smoker status, history of PONV and/or motion sickness, and the use of postoperative opioids. This segmentation helps in tailoring the marketing and sales strategies to effectively target the most at-risk patient populations[1].

Competitive Landscape

APONVIE competes in the antiemetic market, where it stands out as one of the most effective approved agents for preventing vomiting, either alone or in combination with other antiemetics. Its rapid onset of action and favorable safety profile position it strongly against competitors like ondansetron[1].

Sales Performance and Revenue Growth

Since its approval, APONVIE has shown promising sales growth. In Q2 2024, APONVIE net revenues doubled compared to Q1 2024, reaching $1 million. For the nine months ended September 30, 2024, APONVIE net product sales were $2.6 million, up from $0.9 million in the same period in 2023. This growth is attributed to the refined sales message and improved incentive compensation plans implemented by Heron Therapeutics[2][4].

Strategic Sales and Marketing Efforts

Heron Therapeutics has focused on refining its sales message to emphasize the financial and clinical benefits of APONVIE in the perioperative space. This strategy shift, implemented in October 2023, has led to over 70 Pharmacy and Therapeutics (P&T) committee wins, with an additional 35 wins in the subsequent quarter. These systematic wins at the P&T and formulary level are crucial as they can lead to protocol changes that favor the use of APONVIE in hospital systems[5].

Financial Trajectory of Heron Therapeutics

Revenue Growth

Heron Therapeutics has experienced significant revenue growth, driven partly by the performance of APONVIE and its other products. In the first half of 2024, the company saw a 15% increase in revenues compared to the same period in 2023. The oncology franchise, which includes CINVANTI and SUSTOL, also contributed substantially to this growth[2].

Gross Margin Improvement

The company has improved its gross margins significantly, from 40% in the first half of 2023 to 73% in the first half of 2024. This improvement is a result of better financial management and operational efficiencies[2].

Operating Expense Reduction

Heron Therapeutics has reduced its operating expenses dramatically, cutting over $36 million in expenses in the first six months of 2024 compared to the same period in 2023. This reduction, along with the revenue growth, has helped in narrowing the net loss and positioning the company for future profitability[2].

Capital Raise and Path to Profitability

A capital raise completed in 2023 is expected to support Heron's path to profitability by Q4 2024. The company has reaffirmed its revenue guidance for 2024 between $138 million and $158 million, with improved gross margins and reduced operating expenses[3].

Key Partnerships and Expansions

CrossLink Partnership

The partnership with CrossLink is anticipated to boost revenue for both ZYNRELEF and APONVIE. This partnership, along with the expanded label for ZYNRELEF, is expected to have a significant impact on sales as it frees up more selling time for the sales team and enhances pull-through in hospital systems[2].

ASC Market Focus

Heron Therapeutics is focusing on the Ambulatory Surgery Center (ASC) market, where products like ZYNRELEF and APONVIE are well-aligned with current needs and enhanced recovery protocols. This focus is expected to drive further revenue growth and market penetration[3].

Future Outlook

The future outlook for APONVIE is promising, given its strong market positioning and the ongoing efforts to improve sales strategies. With the anticipated approvals of other projects like the VAN and Prefilled Syringe, Heron Therapeutics is set to further solidify its presence in the antiemetic and acute care markets[3].

Key Takeaways

• Substantial Market Opportunity: APONVIE targets a large market with 36 million annual procedures involving patients at moderate to high risk for PONV.
• Refined Sales Strategy: The focus on PONV prevention and financial benefits has led to significant P&T wins and revenue growth.
• Financial Improvements: Heron Therapeutics has improved gross margins and reduced operating expenses, positioning itself for future profitability.
• Key Partnerships: The CrossLink partnership and expanded ZYNRELEF label are expected to boost revenue.
• ASC Market Focus: The company is leveraging the ASC market to drive further growth and penetration.

FAQs

What is APONVIE used for?

APONVIE is used for the prevention of postoperative nausea and vomiting (PONV) in adults.

How is APONVIE administered?

APONVIE is administered via a 30-second intravenous (IV) push.

What is the market size for PONV prevention?

The market involves approximately 36 million annual procedures with patients at moderate to high risk for PONV.

How has Heron Therapeutics' revenue and gross margin changed?

Heron Therapeutics has seen a 15% revenue growth and improved its gross margins from 40% to 73% in the first half of 2024 compared to the same period in 2023.

What are the key factors driving APONVIE's sales growth?

The refined sales message focusing on PONV prevention and financial benefits, along with P&T committee wins and key partnerships, are driving APONVIE's sales growth.

Sources

1. Heron Therapeutics - APONVIE™ (HTX-019) FDA Approval September 19, 2022
2. Investing.com - Earnings call: Heron Therapeutics experienced a 15% increase in revenues
3. Investing.com - Earnings call: Heron Therapeutics outlines progress and forecasts profitability
4. Heron Therapeutics - Heron Therapeutics Announces Third Quarter 2024 Financial Results
5. Investing.com - Earnings call: Heron Therapeutics reports revenue growth in Q1 2024