HERON THERAPS INC Company Profile

What is the competitive landscape for HERON THERAPS INC

HERON THERAPS INC has four approved drugs.

There are twenty-nine US patents protecting HERON THERAPS INC drugs.

There are eighty-one patent family members on HERON THERAPS INC drugs in twenty countries and seven supplementary protection certificates in four countries.

Summary for HERON THERAPS INC

International Patents:	81
US Patents:	29
Tradenames:	4
Ingredients:	3
NDAs:	4

Drugs and US Patents for HERON THERAPS INC

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	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-004	May 12, 2021		RX	Yes	Yes	11,083,797		Y
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-002	May 12, 2021		RX	Yes	Yes	11,083,730		Y
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-001	May 12, 2021		DISCN	Yes	No	11,253,504
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-003	May 12, 2021		DISCN	Yes	No	9,744,163		Y
Heron Theraps Inc	ZYNRELEF KIT	bupivacaine; meloxicam	SOLUTION, EXTENDED RELEASE;PERIARTICULAR	211988-001	May 12, 2021		DISCN	Yes	No

Expired US Patents for HERON THERAPS INC

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016	10,357,570
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016	8,715,710
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016	8,252,304
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016	6,613,355
Heron Theraps Inc	SUSTOL	granisetron	INJECTABLE;SUBCUTANEOUS	022445-001	Aug 9, 2016	8,252,305

International Patents for HERON THERAPS INC Drugs

Country	Patent Number	Estimated Expiration
Japan	2022082776
Lithuania	3134068
Slovenia	3134068
Taiwan	I653984
World Intellectual Property Organization (WIPO)	2016044784

Supplementary Protection Certificates for HERON THERAPS INC Drugs

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	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
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
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

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Heron Theraps Inc

Pharmaceutical Competitive Landscape Analysis: HERON THERAPEUTICS INC – Market Position, Strengths & Strategic Insights

Introduction to Heron Therapeutics

Heron Therapeutics, Inc. (NASDAQ: HRTX) is a biotechnology company that has carved out a niche in the pharmaceutical industry by focusing on developing innovative therapies for patients suffering from cancer and acute pain. Founded in 2006, the company has steadily grown its portfolio of proprietary products, leveraging its unique polymer-based drug delivery platform to address unmet medical needs.

Heron's Market Position

In the competitive pharmaceutical landscape, Heron Therapeutics has positioned itself as a specialist in oncology supportive care and acute pain management. The company's market position is characterized by its focus on developing novel, patient-focused drugs that improve upon existing treatment options.

Key Products and Their Market Impact

Heron's product lineup includes several FDA-approved medications that have made significant impacts in their respective markets:

1. SUSTOL: An extended-release injection for preventing chemotherapy-induced nausea and vomiting (CINV).
2. CINVANTI: An injectable emulsion for CINV prevention.
3. ZYNRELEF: A solution for postoperative pain management.
4. APONVIE: A treatment for preventing postoperative nausea and vomiting (PONV).

These products have helped Heron establish a strong presence in the oncology supportive care and acute pain management sectors.

Financial Performance

Heron's financial performance reflects its growing market presence. In the third quarter of 2024, the company reported:

Reported positive YTD 2024 Adjusted EBITDA of $1.4 million[1]

This positive EBITDA is a significant milestone for Heron, indicating progress towards profitability. The company also provided guidance for Q4 2024, expecting net revenue in the range of $37 million to $43 million[1].

Heron's Competitive Strengths

Innovative Drug Delivery Technology

At the core of Heron's competitive advantage is its proprietary Biochronomer® drug delivery technology. This polymer-based platform allows for the development of extended-release formulations, improving the therapeutic profile of injectable pharmaceuticals. The uniqueness of this technology provides Heron with a significant edge in drug development and differentiation in the market.

Strong R&D Capabilities

Heron's commitment to research and development is evident in its substantial investment in this area. In 2022, the company reported R&D expenses of $141.7 million[3], demonstrating its dedication to innovation and pipeline development.

Focused Product Portfolio

While some might view a limited product portfolio as a weakness, Heron has turned this into a strength by focusing intensely on specific therapeutic areas. This focused approach allows the company to develop deep expertise and strong market positioning in its chosen fields.

Strategic Partnerships

Heron has demonstrated skill in forming strategic partnerships to enhance its market reach. For example, the company launched a partnership with CrossLink Life Sciences, LLC in the first quarter of 2024 to expand promotional efforts for ZYNRELEF[10]. Such partnerships can significantly boost market penetration and sales without requiring substantial increases in internal resources.

Market Opportunities and Growth Prospects

Expanding Pain Management Market

The global pain management market presents a significant opportunity for Heron. Projected to reach $89.3 billion by 2027, with a CAGR of 4.6%[2], this market offers substantial growth potential for Heron's innovative pain management solutions.

Oncology Supportive Care Market Growth

The oncology supportive care market is another area of opportunity for Heron. Expected to grow from $24.6 billion in 2022 to $36.8 billion by 2027 (CAGR of 8.4%)[2], this market aligns well with Heron's existing product portfolio and expertise.

International Expansion

While currently focused on the U.S. market, Heron has the potential to expand internationally. The company's innovative products could address global healthcare challenges, particularly in oncology and pain management sectors.

Competitive Challenges and Threats

Intense Competition

The pharmaceutical industry is highly competitive, with numerous well-established players and new entrants constantly emerging. Heron faces competition from both large pharmaceutical companies with extensive resources and smaller, specialized firms focusing on similar therapeutic areas.

Regulatory Hurdles

Like all pharmaceutical companies, Heron must navigate complex regulatory environments. Changes in regulations or delays in approvals can significantly impact the company's product development timelines and market entry.

Financial Pressures

Despite recent improvements in financial performance, Heron still faces financial challenges. The company reported a net loss of $146.1 million in 2022[3], highlighting the ongoing need for careful financial management and the importance of achieving sustained profitability.

Strategic Insights and Future Outlook

Focus on Commercial Execution

With several FDA-approved products in its portfolio, Heron's near-term strategy likely involves maximizing the commercial potential of these assets. This includes expanding market share for existing products and potentially exploring new indications or formulations.

Pipeline Development

Continuing to invest in R&D and advancing its pipeline will be crucial for Heron's long-term success. The company's expertise in extended-release formulations provides a solid foundation for developing new, innovative therapies.

Potential for Strategic Partnerships or M&A

Given the high level of M&A activity in the biotech sector (valued at $96.4 billion in 2022[2]), Heron could potentially explore strategic partnerships or even become an acquisition target for larger pharmaceutical companies looking to bolster their oncology or pain management portfolios.

Expansion of Indications

Heron has demonstrated success in expanding indications for its existing products. For example, the FDA approval of an expanded indication for ZYNRELEF in January 2024[10] opens up new market opportunities. Continuing this strategy could help Heron maximize the value of its current portfolio.

Key Takeaways

1. Heron Therapeutics has established a strong position in oncology supportive care and acute pain management through its innovative drug delivery technology and focused product portfolio.

2. The company's financial performance is improving, with positive YTD 2024 Adjusted EBITDA and projected revenue growth.

3. Significant market opportunities exist in the expanding pain management and oncology supportive care markets.

4. Heron faces competitive challenges and financial pressures but has strategic options for growth, including commercial execution, pipeline development, and potential partnerships or M&A activities.

5. The company's future success will likely depend on its ability to maximize the potential of its current products, advance its pipeline, and navigate the competitive and regulatory landscape effectively.

FAQs

1. Q: What are Heron Therapeutics' main products? A: Heron's main products include SUSTOL and CINVANTI for chemotherapy-induced nausea and vomiting, ZYNRELEF for postoperative pain, and APONVIE for postoperative nausea and vomiting.

2. Q: How does Heron's Biochronomer technology work? A: Biochronomer is a polymer-based drug delivery platform that allows for extended-release formulations, improving the therapeutic profile of injectable pharmaceuticals.

3. Q: What are the primary markets Heron Therapeutics operates in? A: Heron primarily operates in the oncology supportive care and acute pain management markets.

4. Q: Has Heron Therapeutics achieved profitability? A: While Heron reported positive YTD 2024 Adjusted EBITDA, the company has not yet achieved sustained profitability.

5. Q: What are the main growth opportunities for Heron Therapeutics? A: Key growth opportunities include expanding in the pain management and oncology supportive care markets, international expansion, and potential new indications for existing products.

Sources cited: [1] https://ir.herontx.com/news-releases/news-release-details/heron-therapeutics-announces-third-quarter-2024-financial [2] https://dcfmodeling.com/products/hrtx-swot-analysis [3] https://dcfmodeling.com/products/hrtx-vrio-analysis [10] https://ir.herontx.com/news-releases/news-release-details/heron-therapeutics-announces-first-quarter-2024-financial