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Last Updated: March 28, 2025

Azurity Company Profile


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Summary for Azurity

Drugs and US Patents for Azurity

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Azurity ERYTHROCIN STEARATE erythromycin stearate TABLET;ORAL 060359-001 Approved Prior to Jan 1, 1982 RX No Yes ⤷  Try for Free ⤷  Try for Free
Azurity MYHIBBIN mycophenolate mofetil SUSPENSION;ORAL 216482-001 May 1, 2024 RX Yes Yes 12,194,143 ⤷  Try for Free Y ⤷  Try for Free
Azurity XATMEP methotrexate sodium SOLUTION;ORAL 208400-001 Apr 25, 2017 RX Yes Yes 10,610,485 ⤷  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
Showing 1 to 3 of 3 entries

Expired US Patents for Azurity

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Azurity EDARBYCLOR azilsartan kamedoxomil; chlorthalidone TABLET;ORAL 202331-001 Dec 20, 2011 5,736,555 ⤷  Try for Free
Azurity EVEKEO ODT amphetamine sulfate TABLET, ORALLY DISINTEGRATING;ORAL 209905-001 Jan 30, 2019 10,130,580 ⤷  Try for Free
Azurity HORIZANT gabapentin enacarbil TABLET, EXTENDED RELEASE;ORAL 022399-002 Dec 13, 2011 8,048,917 ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 3 of 3 entries
Paragraph IV (Patent) Challenges for AZURITY drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Extended-release Tablets 300 mg ➤ Subscribe 2006-05-19
➤ Subscribe Oral Solution 1 mg/mL ➤ Subscribe 2018-08-31
➤ Subscribe Extended-release Tablets 100 mg and 200 mg ➤ Subscribe 2006-07-20
➤ Subscribe Powder for Oral Solution 1 mg/mL ➤ Subscribe 2016-06-21

Supplementary Protection Certificates for Azurity Drugs

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
2317997 2190050-1 Sweden ⤷  Try for Free PRODUCT NAME: PHENTERMINE AND TOPIRAMATE; NAT. REG. NO/DATE: 59574-59577 20210617; FIRST REG.: IS IS/1/21/018/01-04 20210212
1915993 300625 Netherlands ⤷  Try for Free PRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414
1412357 SPC/GB07/046 United Kingdom ⤷  Try for Free PRODUCT NAME: SITAGLIPTIN PHOSPHATE MONOHYDRATE; REGISTERED: UK EU/1/07/383/001 20070323; UK EU/1/07/383/002 20070323; UK EU/1/07/383/003 20070323; UK EU/1/07/383/004 20070323; UK EU/1/07/383/005 20070323; UK EU/1/07/383/006 20070323; UK EU/1/07/383/007 20070323; UK EU/1/07/383/008 20070323; UK EU/1/07/383/009 20070323; UK EU/1/07/383/010 20070323; UK EU/1/07/383/011 20070323; UK EU/1/07/383/012 20070323; UK EU/1/07/383/013 20070323; UK EU/1/07/383/014 20070323; UK EU/1/07/383/015 20070323; UK EU/1/07/383/016 20070323; UK EU/1/07/383/017 20070323; UK EU/1/07/383/018 20070323
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 3 of 3 entries
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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

Azurity Pharmaceuticals has carved out a unique niche in the pharmaceutical industry by focusing on innovative medications for underserved patients. This privately held specialty pharmaceutical company, headquartered in Boston, Massachusetts, has been making waves with its patient-centric approach and strategic acquisitions. Let's dive deep into Azurity's market position, strengths, and strategic insights to understand how this company is positioning itself for success in a highly competitive landscape.

Company Overview

Azurity Pharmaceuticals specializes in providing high-quality, innovative medicines that cater to overlooked patient populations[1]. The company's product portfolio spans across various therapeutic areas, including cardiovascular, central nervous system, endocrine, gastrointestinal, anti-infective, and oncology medicines[1]. What sets Azurity apart is its focus on dose-form innovations, developing new medical options for patients whose needs are not met by currently available therapies[3].

"We are driven by our passion for innovation and patient well-being. We are proud to offer patient-centered solutions and are constantly looking to create new possibilities for overlooked patients." - Azurity Pharmaceuticals[3]

Market Position

Therapeutic Areas

Azurity has strategically positioned itself across multiple therapeutic areas, allowing for diversification and reduced risk. The company's products serve patients in the following markets[4]:

  1. Cardiovascular
  2. Neurology
  3. Endocrinology
  4. Gastrointestinal
  5. Institutional
  6. Orphan diseases

This broad spectrum of therapeutic areas enables Azurity to tap into various market segments and cater to a wide range of patient needs.

Product Portfolio

Azurity's product portfolio is impressive, with over 32 products currently on the market[10]. This extensive range includes:

  • 10 exclusively promoted, FDA-approved, branded product families
  • More than 30 total commercialized products
  • A robust pipeline of mid and late-stage products under development[2]

The company's ability to consistently launch new products each year demonstrates its commitment to innovation and meeting unmet patient needs[3].

Market Reach

While specific market share data is not available, Azurity's acquisition strategy and growing product portfolio suggest a significant and expanding market presence. The company's focus on underserved patient populations also indicates a strategic approach to capturing niche markets with less competition.

Strengths and Competitive Advantages

1. Focus on Underserved Patients

Azurity's primary strength lies in its dedication to serving overlooked patients. By developing dose-form innovations of established medicines for patients with unmet needs, the company has created a unique value proposition in the pharmaceutical market[5].

2. Dose-Form Innovation

The company has an acknowledged strength in dose-form innovation, developing new medical options for patients who have needs not met by what is currently available[3]. This focus on innovation allows Azurity to differentiate itself from competitors and create barriers to entry in its chosen markets.

3. Diverse Product Portfolio

With products spanning six broad therapeutic areas and seven different dosage forms, Azurity has built a diverse and robust product portfolio[3]. This diversity helps mitigate risks associated with market fluctuations in any single therapeutic area.

4. Strong R&D Capabilities

Azurity's development scientists in Kansas City and Hyderabad are working on multiple prototypes for new medicines. The company currently has 26 projects in its development pipeline, showcasing its commitment to ongoing innovation[3].

5. Strategic Acquisitions

Azurity has demonstrated a keen eye for strategic acquisitions that complement its existing capabilities. The recent acquisition of Slayback Pharma, for instance, is expected to accelerate Azurity's strategic growth plan and enhance its ability to launch multiple innovative new drug products annually[1].

6. Patient-Centric Approach

The company's patient-centric approach is evident in its diverse array of products catering to various medical needs. Many of Azurity's medicines are dose-form innovations for patients with needs that are not met by other commercially available therapies[1].

Strategic Insights

1. Expansion through Acquisitions

Azurity's acquisition strategy has been a key driver of its growth. The company's recent acquisitions, including Slayback Pharma and Arbor Pharmaceuticals, have significantly expanded its product portfolio and R&D capabilities[1][2].

2. Focus on Rare and Orphan Conditions

Many of Azurity's medicines serve the needs of small patient groups, treating rare or "orphan" conditions. This focus on niche markets allows the company to establish a strong presence in areas with less competition[3].

3. Leveraging Integrated Capabilities

Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust pipeline[4]. This approach allows the company to maximize its resources and accelerate product development.

4. Emphasis on Quality and Accessibility

As an industry leader in providing unique, accessible, and high-quality medications, Azurity has positioned itself as a trusted provider of essential medicines[6]. This reputation for quality and accessibility is crucial in building long-term relationships with healthcare providers and patients.

5. Investment in R&D

Azurity's robust pipeline and ongoing R&D efforts demonstrate its commitment to future growth. The company's focus on developing new products ensures a steady stream of innovations to meet evolving patient needs[3].

Market Trends and Opportunities

Super Generics Market Growth

The super generics market, in which Azurity operates, is expected to grow significantly. Estimates suggest an increase from USD 84 billion in 2024 to USD 200 billion by 2035, at a CAGR of 8%[8]. This growth presents substantial opportunities for companies like Azurity that specialize in innovative formulations of existing drugs.

Increasing Demand for Personalized Medicine

The trend towards personalized medicine aligns well with Azurity's focus on developing tailored formulations for specific patient groups. As healthcare becomes more personalized, Azurity's expertise in dose-form innovations could become increasingly valuable.

Growing Geriatric and Pediatric Markets

Azurity's focus on adapting medications for geriatric and pediatric patients positions it well to capitalize on the growing demand in these demographics. As the global population ages and awareness of pediatric-specific medication needs increases, Azurity's specialized formulations could see increased demand.

Challenges and Potential Threats

Regulatory Hurdles

As with all pharmaceutical companies, Azurity faces ongoing regulatory challenges. The need to navigate complex approval processes for new formulations and products can impact time-to-market and development costs.

Competition from Large Pharma Companies

While Azurity has carved out a niche in underserved markets, there's always the risk of larger pharmaceutical companies entering these spaces. Azurity will need to maintain its innovative edge to stay competitive.

Pricing Pressures

The pharmaceutical industry faces ongoing pressure to reduce drug prices. As a company focused on specialized formulations, Azurity may need to navigate challenges in justifying premium pricing for its innovative products.

Future Outlook

Azurity Pharmaceuticals appears well-positioned for future growth. Its focus on underserved patient populations, commitment to innovation, and strategic acquisition strategy provide a solid foundation for expansion. The company's robust pipeline and ongoing R&D efforts suggest a steady stream of new products in the coming years.

As the healthcare landscape continues to evolve towards more personalized and patient-centric care, Azurity's specialized approach could become increasingly valuable. However, the company will need to navigate regulatory challenges, potential competition, and pricing pressures to maintain its growth trajectory.

Key Takeaways

  1. Azurity Pharmaceuticals has established a strong market position by focusing on innovative medications for underserved patients.
  2. The company's strengths lie in its dose-form innovations, diverse product portfolio, and strategic acquisitions.
  3. Azurity's patient-centric approach and focus on rare and orphan conditions differentiate it from competitors.
  4. The company's robust pipeline and ongoing R&D efforts position it well for future growth.
  5. Azurity faces challenges including regulatory hurdles, potential competition from larger pharma companies, and pricing pressures.
  6. The growing super generics market and trends towards personalized medicine present significant opportunities for Azurity.

FAQs

  1. What makes Azurity Pharmaceuticals unique in the pharmaceutical industry? Azurity stands out due to its focus on developing innovative dose-form medications for underserved patient populations, particularly in areas where existing therapies don't meet patient needs.

  2. How many products does Azurity currently have on the market? Azurity has over 32 products currently on the market, including 10 exclusively promoted, FDA-approved, branded product families.

  3. What therapeutic areas does Azurity specialize in? Azurity's products span cardiovascular, neurology, endocrinology, gastrointestinal, institutional, and orphan markets.

  4. How is Azurity positioning itself for future growth? Azurity is focusing on strategic acquisitions, ongoing R&D efforts, and a robust pipeline of new products to drive future growth.

  5. What are the main challenges Azurity faces in the pharmaceutical market? Key challenges include navigating regulatory hurdles, potential competition from larger pharmaceutical companies, and addressing pricing pressures in the industry.

Sources cited: [1] https://azurity.com/azurity-pharmaceuticals-acquires-slayback-pharma/ [2] https://azurity.com/azurity-pharmaceuticals-to-acquire-and-merge-with-arbor-pharmaceuticals/ [3] https://azurity.com/pipeline/ [4] https://builtin.com/job/strategic-account-manager-south-east/3836553 [5] https://azurity.com/about-us/ [6] https://leadiq.com/c/azurity-pharmaceuticals/5a1d85ff24000024006064cf [8] https://www.rootsanalysis.com/reports/super-generics-market/275.html [10] https://www.schlafenderhase.com/case-studies/case-study-azurity-effortless-comparison-in-labeling-and-promotional-review

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