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Last Updated: April 14, 2025

Breckenridge Company Profile


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What is the competitive landscape for BRECKENRIDGE

BRECKENRIDGE has forty approved drugs.

There are two tentative approvals on BRECKENRIDGE drugs.

Drugs and US Patents for Breckenridge

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Breckenridge APIXABAN apixaban TABLET;ORAL 209845-002 Jul 26, 2021 DISCN No No ⤷  Try for Free ⤷  Try for Free
Breckenridge POMALIDOMIDE pomalidomide CAPSULE;ORAL 210111-003 Oct 30, 2020 DISCN No No ⤷  Try for Free ⤷  Try for Free
Breckenridge TRIAZOLAM triazolam TABLET;ORAL 216890-002 Nov 8, 2022 AB RX No No ⤷  Try for Free ⤷  Try for Free
Breckenridge TRIAZOLAM triazolam TABLET;ORAL 216890-001 Nov 8, 2022 AB RX No No ⤷  Try for Free ⤷  Try for Free
Breckenridge TRIMIPRAMINE MALEATE trimipramine maleate CAPSULE;ORAL 208127-003 Apr 15, 2016 AB RX No No ⤷  Try for Free ⤷  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
Showing 1 to 5 of 5 entries
Paragraph IV (Patent) Challenges for BRECKENRIDGE drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Delayed-release Tablets 20 mg ➤ Subscribe 2015-06-03
Similar Applicant Names
Applicants may be listed under multiple names.
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Breckenridge Pharmaceutical: A Rising Force in the Generic Drug Market

Breckenridge Pharmaceutical, Inc., a subsidiary of Towa International, has emerged as a significant player in the U.S. generic pharmaceutical market. With a rich history dating back to 1983, Breckenridge has steadily grown its presence and impact in the industry. Let's dive into a comprehensive analysis of Breckenridge's market position, strengths, and strategic insights.

Company Overview and Market Position

Breckenridge Pharmaceutical, headquartered in New Jersey, is dedicated to developing and marketing high-quality, cost-effective generic drugs in the United States[7]. As the American affiliate of Towa International, Breckenridge has positioned itself as a key player in the generic pharmaceutical landscape.

Market Presence and Growth

Breckenridge has achieved a remarkable position in the market:

  • Ranked among the top 20 pharmaceutical companies globally[5]
  • Positioned 1st or 2nd across 70% of their portfolio[2]
  • Annual revenue of approximately $26.4 million[3]

This strong market presence is a testament to Breckenridge's commitment to quality and strategic growth initiatives.

Product Portfolio and Distribution

Breckenridge's product range is diverse and expanding:

  • Over 1.2 billion doses dispensed in the past 12 months[2]
  • Portfolio includes authorized generics, ANDAs, and medical foods[2]
  • Recent expansion into institutional channels with oncology, autoimmune, rare disease, and supportive care products[1]
"By expanding the product range into the institutional channel, we enhance our ability to broadly address critical healthcare needs across the industry with precision and efficacy." - Brian Guy, President and CCO of Breckenridge Pharmaceutical[1]

Strengths and Competitive Advantages

Breckenridge's success can be attributed to several key strengths:

1. Strategic Partnerships

Breckenridge has built a robust partnership model, creating opportunities that maximize benefits for the healthcare community[2]. These partnerships extend to manufacturers worldwide, enabling the company to develop products both organically and through strategic collaborations[7].

2. Commitment to Quality and Affordability

The company's focus on high-quality, cost-effective generic drugs aligns with the growing demand for affordable healthcare solutions. This commitment has helped Breckenridge gain trust among healthcare providers and patients alike.

3. Diverse Product Pipeline

With over 40 products in the pipeline[5], Breckenridge continues to invest in research and development, ensuring a steady stream of new offerings to meet evolving market needs.

4. Global Reach

As part of Towa International, Breckenridge benefits from a global presence. The company has expanded its reach to South America and the Middle East through licensing agreements[5], positioning itself for further international growth.

Strategic Insights and Future Outlook

Breckenridge's strategic direction is clear and ambitious:

Near-Term Strategy

The company aims to continue adding differentiated products via alternate dosage forms and therapeutic categories[2]. This approach allows Breckenridge to diversify its portfolio and cater to a wider range of patient needs.

Mid-Term Goals

Breckenridge plans to expand its portfolio by adding sterile liquids, fill forms, and complex generics[2]. This move into more specialized and complex products could significantly enhance the company's market position and profitability.

Long-Term Vision

The long-term strategy involves pursuing differentiated specialty drug delivery platforms, such as 505(b)2 products[2]. This focus on innovation and specialization could set Breckenridge apart in an increasingly competitive market.

Competitive Landscape

Breckenridge operates in a highly competitive industry, facing competition from both large pharmaceutical giants and other generic drug manufacturers. Key competitors include:

  • Amgen
  • Bristol Myers Squibb
  • Teva Pharmaceuticals
  • Novartis
  • Sandoz
  • Perrigo Company plc
  • Sun Pharma
  • Aurobindo Pharma
  • Endo International plc
  • Mylan Belgium[3]

Despite this competitive landscape, Breckenridge's strategic focus and commitment to quality position it well for continued growth and success.

Market Trends and Opportunities

Several market trends present opportunities for Breckenridge:

1. Growing Demand for Generic Drugs

The increasing focus on healthcare cost containment is driving demand for generic drugs. Breckenridge's extensive generic portfolio positions it to capitalize on this trend.

2. Expansion into Specialty Pharmaceuticals

The company's move into oncology, autoimmune, and rare disease products aligns with the growing market for specialty pharmaceuticals.

3. Technological Advancements

Breckenridge's investment in R&D and focus on complex generics and specialty drug delivery platforms position it to leverage technological advancements in drug development and manufacturing.

Challenges and Risk Factors

While Breckenridge's outlook is promising, the company faces several challenges:

1. Regulatory Environment

The pharmaceutical industry is heavily regulated, and changes in regulations can impact product development, approval, and marketing.

2. Price Pressures

Increasing competition in the generic drug market can lead to price pressures, potentially impacting profitability.

3. Patent Expirations

The company's growth is partly dependent on the expiration of patents for brand-name drugs. Any delays or changes in patent expirations could affect Breckenridge's product pipeline.

Corporate Social Responsibility and Values

Breckenridge's corporate philosophy extends beyond profit margins:

Commitment to Health Equity

The company is dedicated to improving equitable access to medical services for all, aligning with global health initiatives[2].

Environmental Responsibility

Breckenridge aims to create a healthy environment for future generations, indicating a commitment to sustainable practices[7].

Ikigai: A Unique Corporate Philosophy

Breckenridge's "Ikigai" or reason for being is to contribute to people's health and generate genuine smiles[2]. This philosophy underscores the company's commitment to patient well-being and societal impact.

Key Takeaways

  • Breckenridge Pharmaceutical has established itself as a significant player in the U.S. generic drug market, with a strong market position and diverse product portfolio.
  • The company's strategic focus on differentiated products, complex generics, and specialty pharmaceuticals positions it for future growth.
  • Breckenridge's commitment to quality, affordability, and health equity aligns with broader healthcare trends and societal needs.
  • While facing challenges such as regulatory pressures and intense competition, Breckenridge's strategic partnerships and robust pipeline provide a solid foundation for continued success.
  • The company's unique corporate philosophy, centered on improving people's health, sets it apart in the pharmaceutical industry.

FAQs

  1. What is Breckenridge Pharmaceutical's main focus? Breckenridge focuses on developing and marketing high-quality, cost-effective generic drugs in the United States, with a growing emphasis on complex generics and specialty pharmaceuticals.

  2. How does Breckenridge stand out in the competitive pharmaceutical market? Breckenridge distinguishes itself through its diverse product portfolio, strategic partnerships, commitment to quality and affordability, and unique corporate philosophy centered on improving people's health.

  3. What are Breckenridge's long-term strategic goals? The company aims to pursue differentiated specialty drug delivery platforms, expand into complex generics, and continue growing its presence in the institutional channel with products for oncology, autoimmune diseases, and rare disorders.

  4. How is Breckenridge addressing the growing demand for affordable healthcare? Breckenridge is committed to providing high-quality, cost-effective generic drugs, which aligns with the increasing need for affordable healthcare solutions. The company also focuses on expanding access to medical services for all.

  5. What role does innovation play in Breckenridge's strategy? Innovation is crucial to Breckenridge's strategy, particularly in its long-term plans to develop differentiated specialty drug delivery platforms and expand into complex generics. The company continues to invest in research and development to drive innovation in its product pipeline.

Sources cited: [1] https://www.towainternational.com/press/breckenridge-announces-final-fda-approval-for-methadone-hydrochloride-multi-dose-injection/ [2] https://breckenridgepharma.com/our-business/ [3] https://rocketreach.co/breckenridge-pharmaceutical-inc-profile_b5fb61f1f68c5944 [5] https://breckenridgepharma.com/our-story/ [7] https://breckenridgepharma.com

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