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Last Updated: March 24, 2025

Bdsi Company Profile


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Summary for Bdsi
International Patents:176
US Patents:9
Tradenames:3
Ingredients:3
NDAs:3

Drugs and US Patents for Bdsi

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bdsi SYMPROIC naldemedine tosylate TABLET;ORAL 208854-001 Mar 23, 2017 RX Yes Yes 10,952,968 ⤷  Try for Free Y Y ⤷  Try for Free
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-003 Oct 23, 2015 RX Yes No 9,901,539 ⤷  Try for Free ⤷  Try for Free
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-003 Jun 6, 2014 DISCN Yes No 8,147,866 ⤷  Try for Free Y ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for Bdsi

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-001 Oct 23, 2015 6,159,498 ⤷  Try for Free
Bdsi BELBUCA buprenorphine hydrochloride FILM;BUCCAL 207932-005 Oct 23, 2015 6,159,498 ⤷  Try for Free
Bdsi BUNAVAIL buprenorphine hydrochloride; naloxone hydrochloride FILM;BUCCAL 205637-001 Jun 6, 2014 6,159,498 ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for BDSI drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Buccal Film 900 mcg ➤ Subscribe 2016-09-12
➤ Subscribe Buccal Film 75 mcg and 150 mcg ➤ Subscribe 2016-10-24
➤ Subscribe Buccal Film 2.1mg/0.3 mg and 4.2 mg/0.7 mg ➤ Subscribe 2016-11-23
➤ Subscribe Buccal Film 300 mcg, 450 mcg, 600 mcg and 750 mcg ➤ Subscribe 2016-10-04
➤ Subscribe Buccal Film 6.3 mg/1 mg ➤ Subscribe 2015-12-21

Supplementary Protection Certificates for Bdsi Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1889848 1990036-4 Sweden ⤷  Try for Free PRODUCT NAME: NALDEMEDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEROF, IN PARTICULAR THE TOSYLATE SALT; REG. NO/DATE: EU/1/18/1291 20190220
1889848 2019C/533 Belgium ⤷  Try for Free PRODUCT NAME: NALMEDINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN, IN BIJZONDER HET TOSYLAATZOUT; AUTHORISATION NUMBER AND DATE: EU/1/18/1291 20190220
1889848 2019/038 Ireland ⤷  Try for Free PRODUCT NAME: NALDEMEDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR THE TOSYLATE SALT.; REGISTRATION NO/DATE: EU/1/18/1291 20190218
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

Pharmaceutical Competitive Landscape Analysis: BDSI – Market Position, Strengths & Strategic Insights

In the fiercely competitive pharmaceutical industry, understanding the market landscape is crucial for success. This comprehensive analysis delves into BioDelivery Sciences International Inc. (BDSI), examining its market position, strengths, and strategic insights. By exploring BDSI's competitive landscape, we'll uncover valuable information for industry professionals, investors, and decision-makers.

BDSI: An Overview

BioDelivery Sciences International Inc. is a specialty pharmaceutical company focused on developing and commercializing innovative therapies for pain management and neurology. Founded in 1997, BDSI has established itself as a key player in the pharmaceutical sector, particularly in the areas of chronic pain and opioid dependence treatment[1].

Core Products and Focus Areas

BDSI's product portfolio primarily revolves around two key areas:

  1. Pain Management: BELBUCA® (buprenorphine buccal film) for chronic pain
  2. Neurology: ELYXYB™ (celecoxib oral solution) for acute migraine treatment

These products form the backbone of BDSI's market presence and revenue generation[5].

Market Position and Financial Performance

As of 2024, BDSI has positioned itself as a notable player in the pharmaceutical industry, particularly in the pain management and neurology sectors. The company's market capitalization stands at $577.05 million, indicating its significant presence in the market[5].

Revenue and Growth

BDSI has demonstrated strong financial performance, with projected total net revenues of $165-$167 million for 2021. This surpasses previous guidance and indicates solid growth in the opioid market despite challenges posed by COVID-19[5].

BELBUCA net sales are anticipated to reach $147-$148 million, showcasing the product's strong market performance and BDSI's ability to capture market share in the pain management sector[5].

Stock Performance

BDSI's stock (NASDAQ: BDSI) has shown resilience in a competitive market. The company's float of 96.03 million shares indicates a relatively liquid stock, which is attractive to investors[5].

BDSI's Competitive Strengths

Understanding BDSI's competitive strengths is crucial for assessing its market position and potential for future growth.

1. Innovative Drug Delivery Technologies

BDSI's core strength lies in its innovative drug delivery technologies. The company's buccal film technology, used in BELBUCA, offers a unique and effective method for drug administration, setting it apart from competitors[1].

2. Strong Product Portfolio

With established products like BELBUCA and the newly acquired ELYXYB, BDSI has a diverse and growing product portfolio. This diversification helps mitigate risks and opens up new revenue streams[5].

3. Focus on Unmet Medical Needs

BDSI's strategic focus on areas with significant unmet medical needs, such as chronic pain management and migraine treatment, positions it well in niche markets with high growth potential[1].

4. Robust Intellectual Property Protection

The company has successfully defended its patents, ensuring exclusivity for key products like BELBUCA until 2032. This intellectual property protection provides a significant competitive advantage and secures future revenue streams[5].

Strategic Insights and Future Outlook

To maintain and improve its competitive position, BDSI has implemented several strategic initiatives:

1. Expansion into New Therapeutic Areas

The acquisition of ELYXYB marks BDSI's entry into the lucrative migraine treatment market, estimated at $1.9 billion. This strategic move diversifies the company's portfolio and taps into a new revenue source[5].

2. Focus on Commercial Execution

BDSI is prioritizing the commercial execution of its existing products, particularly BELBUCA. By optimizing sales and marketing strategies, the company aims to maximize market penetration and revenue growth[1].

3. Investment in R&D

Continued investment in research and development is crucial for BDSI's long-term success. The company's focus on innovative drug delivery technologies positions it well for future product development and market expansion[1].

4. Strategic Partnerships and Acquisitions

BDSI's acquisition of ELYXYB demonstrates its willingness to pursue strategic partnerships and acquisitions to enhance its product portfolio and market position[5].

Competitive Landscape Analysis

To fully understand BDSI's market position, it's essential to analyze the competitive landscape in which it operates.

Key Competitors

  1. Indivior PLC: A direct competitor in the opioid dependence treatment market[2].
  2. INSYS Therapeutics Inc: Competes in the pain management sector[2].
  3. Johnson & Johnson: A major player in the pharmaceutical industry with products in pain management[2].

Market Trends and Challenges

  1. Increasing focus on non-opioid pain management solutions
  2. Growing demand for innovative drug delivery technologies
  3. Regulatory challenges in the opioid market
  4. Increasing competition in the migraine treatment sector

SWOT Analysis

A SWOT analysis provides a comprehensive view of BDSI's current position and future potential.

Strengths

  • Innovative drug delivery technologies
  • Strong product portfolio in pain management and neurology
  • Robust intellectual property protection
  • Successful commercial execution of BELBUCA

Weaknesses

  • Reliance on a limited number of products for revenue
  • Potential vulnerability to regulatory changes in the opioid market
  • Smaller size compared to some major pharmaceutical competitors

Opportunities

  • Expansion into new therapeutic areas (e.g., migraine treatment)
  • Potential for strategic partnerships and acquisitions
  • Growing demand for non-opioid pain management solutions

Threats

  • Intense competition in the pharmaceutical industry
  • Potential for generic competition as patents expire
  • Regulatory challenges and changes in healthcare policies

Strategic Recommendations

Based on the competitive landscape analysis, here are some strategic recommendations for BDSI:

  1. Continue to invest in R&D to maintain technological leadership in drug delivery systems.
  2. Explore partnerships or acquisitions to expand the product portfolio and enter new therapeutic areas.
  3. Focus on international expansion to tap into new markets and diversify revenue streams.
  4. Enhance marketing efforts for ELYXYB to maximize its potential in the migraine treatment market.
  5. Develop a robust pipeline of non-opioid pain management solutions to mitigate regulatory risks.

Key Takeaways

  • BDSI has established a strong market position in pain management and is expanding into neurology with ELYXYB.
  • The company's innovative drug delivery technologies and robust intellectual property protection provide significant competitive advantages.
  • BDSI's focus on unmet medical needs and strategic acquisitions positions it well for future growth.
  • Challenges include intense competition and potential regulatory hurdles in the opioid market.
  • Continued investment in R&D, strategic partnerships, and diversification will be crucial for BDSI's long-term success.

FAQs

  1. Q: What is BDSI's primary focus in the pharmaceutical industry? A: BDSI primarily focuses on developing and commercializing innovative therapies for pain management and neurology.

  2. Q: How does BDSI's drug delivery technology set it apart from competitors? A: BDSI's buccal film technology, used in products like BELBUCA, offers a unique and effective method for drug administration, providing a competitive edge in the market.

  3. Q: What is the significance of BDSI's acquisition of ELYXYB? A: The acquisition of ELYXYB marks BDSI's entry into the lucrative migraine treatment market, diversifying its portfolio and opening up new revenue streams.

  4. Q: How does BDSI protect its intellectual property? A: BDSI has successfully defended its patents, ensuring exclusivity for key products like BELBUCA until 2032, which provides a significant competitive advantage.

  5. Q: What are the main challenges facing BDSI in the current pharmaceutical landscape? A: Key challenges include intense competition, potential regulatory changes in the opioid market, and the need to diversify its product portfolio to reduce reliance on a limited number of revenue sources.

Sources cited: [1] https://www.drugpatentwatch.com/blog/the-importance-of-pharmaceutical-competitor-analysis/ [2] https://pitchgrade.com/companies/biodelivery-sciences-international-inc [5] https://www.stocktitan.net/news/BDSI/

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