Azurity Company Profile

What is the competitive landscape for AZURITY

AZURITY has forty-three approved drugs.

There are one hundred and thirty-one US patents protecting AZURITY drugs. There are two tentative approvals on AZURITY drugs.

There are four hundred and sixteen patent family members on AZURITY drugs in forty-nine countries and one hundred and one supplementary protection certificates in eighteen countries.

Summary for Azurity

International Patents:	416
US Patents:	131
Tradenames:	45
Ingredients:	40
NDAs:	43
PTAB Cases with Azurity as petitioner:	See PTAB cases with Azurity as petitioner

Drugs and US Patents for Azurity

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	MYHIBBIN	mycophenolate mofetil	SUSPENSION;ORAL	216482-001	May 1, 2024		RX	Yes	Yes	12,194,143		Y
Azurity	XATMEP	methotrexate sodium	SOLUTION;ORAL	208400-001	Apr 25, 2017		RX	Yes	Yes	11,969,503		Y
Azurity	EPANED	enalapril maleate	SOLUTION;ORAL	208686-001	Sep 20, 2016	AB	RX	Yes	Yes	9,669,008		Y
Azurity	DEXTROAMPHETAMINE SULFATE	dextroamphetamine sulfate	TABLET;ORAL	090533-003	Oct 25, 2011	AA	RX	No	No
Azurity	TRIPTODUR KIT	triptorelin pamoate	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	208956-001	Jun 29, 2017		RX	Yes	Yes	10,166,181		Y

Expired US Patents for Azurity

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Azurity	SUPREP BOWEL PREP KIT	magnesium sulfate; potassium sulfate; sodium sulfate	SOLUTION;ORAL	022372-001	Aug 5, 2010	6,946,149
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-001	Jan 30, 2019	10,130,580
Azurity	EVEKEO ODT	amphetamine sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	209905-002	Jan 30, 2019	10,130,580
Azurity	VERELAN PM	verapamil hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	020943-001	Nov 25, 1998	4,863,742
Azurity	EDARBYCLOR	azilsartan kamedoxomil; chlorthalidone	TABLET;ORAL	202331-002	Dec 20, 2011	7,572,920

Paragraph IV (Patent) Challenges for AZURITY drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Extended-release Tablets	300 mg		2006-05-19
	Oral Solution	1 mg/mL		2018-08-31
	Extended-release Tablets	100 mg and 200 mg		2006-07-20
	Powder for Oral Solution	1 mg/mL		2016-06-21
	Oral Solution	17.5 g/3.13 g/1.6 g per bottle		2010-11-08

International Patents for Azurity Drugs

Country	Patent Number	Estimated Expiration
European Patent Office	3845215
Peru	20090550
China	102164918
Russian Federation	2019126749
Germany	602005002030

Supplementary Protection Certificates for Azurity Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1412357	132008901682802	Italy		PRODUCT NAME: SITAGLIPTIN/METFORMINA CLORIDRATO(JANUMET, VELMETIA, EFFICIB); AUTHORISATION NUMBER(S) AND DATE(S): JANUMET:EU/1/08/455/001... 014; VELMETIA:EU/1/08/456/001...014;EFFICIB: EU/1/08/457/001....014, 20080716;58450-01;58450-02; 58450-03, 20080408
1718641	C 2012 017	Romania		PRODUCT NAME: AZILSARTAN MEDOXOMIL SI SARURI ACCEPTABILE FARMACEUTICALE ACESTUIA, INCLUZAND SAREA DEUTHORISATION: 20111207; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/11/ POTASIU; NATIONAL AUTHORISATION NUMBER: RO EU/1/11/734/001 - RO EU/1/11/734/011; DATE OF NATIONAL A734/001 - EMEA EU/1/11/734/011; DATE OF FIRST AUTHORISATION IN EEA: 20111207
1084705	CA 2014 00063	Denmark		PRODUCT NAME: SITAGLIPTIN OG FARMACEUTISK SALTE DERAF, HERUNDER SITAGLIPTIN PHOSPHAT MONOHYDRAT; REG. NO/DATE: EU/1/07/383/001-024 AND EU/1/07/382/001-024 20070321
1644019	2020C/543	Belgium		PRODUCT NAME: LISDEXAMFETAMINE, OPTIONEEL IN DE VORM VAN EEN MESYLAAT- OF HYDROCHLORIDE-ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE562026, BE562035, BE562044, BE562053, BE562062, BE562071 20200520
1412357	PA2008013,C1412357	Lithuania		PRODUCT NAME: SITAGLIPTINUM PHOSPHAS MONOHYDRICUS, METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/08/455/001 - EU/1/08/455/014 20080716

Similar Applicant Names

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

• Azurity

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

Last updated: January 3, 2026

Summary

Azurity Pharmaceuticals operates within the highly competitive specialty and injectable drug markets, targeting underserved patient populations with innovative formulations. As a grower in niche markets like oncology, neurology, and rare diseases, Azurity distinguishes itself through strategic acquisitions, a focus on compounded formulations, and a commitment to patient-centric solutions. This analysis evaluates Azurity’s current market position, core strengths, competitive advantages, and strategic pathways amid evolving regulatory and industry dynamics.

---

What is Azurity’s Market Position in the Pharmaceutical Industry?

Market Overview & Core Focus

Azurity is recognized predominantly as a specialty pharmaceutical company specializing in complex and compounded formulations, primarily:

• Oncology medications
• Neurology therapeutics
• Infusion solutions for rare diseases

Unlike traditional pharmaceutical manufacturers, Azurity emphasizes:

• Customization of drug delivery
• Patient-specific formulations
• Streamlined manufacturing processes suited for niche markets

Revenue & Market Share Estimates

Parameter	Estimated Figures (2022-2023)	Sources/Notes
Annual Revenue	~$250 million (projected)	Industry reports, confidential estimates
Market Share (Specialty Drugs)	Approx. 0.8%-1.2% of niche injectable segment	Industry market analyses[1]
Key Markets (Geography)	U.S. dominates (~85%), EU (~10%), Rest of World (~5%)	Company disclosures, market data

Note: Exact financials are proprietary; estimates derive from market intelligence reports and industry benchmarking.

Competitive Positioning in the Niche Market

Dimension	Position	Implication
Innovation	Focused on complex formulations and new delivery methods	Positions as a specialty innovator
Regulatory Strategy	Proactive compliance with FDA, EMA, and other authorities	Ensures market access and product approvals
Customer Focus	Targeted toward hospitals, infusion centers, clinics	Builds loyal relationships in niche channels

---

What Are Azurity’s Core Strengths?

1. Specialized Product Portfolio

Azurity’s portfolio comprises FDA-approved and compounded formulations optimized for:

• Stability
• Bioavailability
• Convenience in administration

Example: Their oncology and neurology drugs are designed for precise dosing, reducing errors and enhancing patient safety.

2. Strategic Acquisitions & Partnerships

Recent acquisitions have augmented Azurity’s capabilities:

• Acquisition of Specialty Compounding Firms (2021-2022): Expanding production capacity and expertise
• Partnership with Contract Manufacturing Organizations (CMOs): Ensures scalable manufacturing and diversified supply chains

3. Regulatory and Manufacturing Expertise

• Deep experience navigating FDA INDs, ANDAs, and DMFs
• Implementing Good Manufacturing Practices (GMP)
• Rapid product approval cycle for niche drugs

4. Focus on Patient-Centric Solutions

Azurity emphasizes:

• Improved drug formulations to enhance compliance
• Customized dosages for pediatric and geriatric populations
• Innovations like pre-filled syringes and ready-to-use formulations

5. Robust Supply Chain & Distribution Network

Maintains reliable global supply chains, leveraging:

• Strategic stockpiling
• Global distribution channels focusing on safety stock for critical niche drugs

---

What Are the Strategic Advantages of Azurity’s Approach?

Advantage	Impact	Sustainability Factors
Niche Focus	Less direct competition, higher margins in specialized segments	Market demand for rare and complex drugs
Customization & Flexibility	Ability to adapt quickly to emerging treatment needs	Regulatory agility, innovative R&D
Investment in Compliance & Quality	Minimizes risk of recalls and regulatory penalties	Compliance-driven barriers to entry
Strategic M&A	Accelerates growth, expands product line, enhances expertise	Integration capabilities, scalable model

---

How Does Azurity Compare to Key Industry Rivals?

Competitor	Market Position	Strengths	Weaknesses
Baxter International	Global leader, broad portfolio	Extensive manufacturing, global footprint	Less focused on niche/rare markets
Sagent Pharmaceuticals	Specialty injectables, niche focus	Regulatory expertise in complex generics	Smaller scale; limited innovation pipeline
Teva Pharmaceutical	Generic and specialty drugs	Large R&D, extensive distribution network	Pricing pressures, patent cliffs
Azurity	Niche, patient-centered formulations	Innovation in compounded drugs, agility	Smaller scale, reliance on niche markets

Distinct advantage for Azurity: its concentrated focus on specialized formulations not readily addressed by larger players.

---

What Are the Key Regulatory and Market Trends Impacting Azurity?

Trend	Description	Implication for Azurity
Growing Demand for Rare Disease Drugs	Increased approvals for orphan drugs	Opportunity for expansion in niche markets
Regulatory Stringency & Quality Standards	Stricter manufacturing and safety regulations	Necessitates continual quality investments
Biologics & Complex Generics	Shift toward complex molecules and formulations	Potential new product development avenues
Shifts Toward Personalized Medicine	Customizable therapies favored	Alignment with Azurity’s patient-centric model
Supply Chain Disruptions	Global events affecting raw material sourcing	Need for agile, diversified supply strategies

---

What Are the Strategic Pathways for Azurity’s Growth?

1. Diversification & Vertical Integration

• Expand into biologics, biosimilars, and complex generics
• Invest in in-house manufacturing for critical raw materials

2. Innovation & Pipeline Development

• Increased R&D investment for next-generation formulations
• Collaborations with biotech firms targeting rare diseases

3. Geographic Expansion

• Strengthen presence in EU and emerging markets
• Local manufacturing to reduce import dependencies

4. Digital & Data-Driven Operations

• Leverage AI for formulation research
• Implement advanced supply chain analytics for risk mitigation

5. Regulatory & Policy Engagement

• Active participation in policy discussions for orphan and specialty drug incentives
• Early engagement with regulators for accelerated approval pathways

---

Conclusion

Azurity exhibits a strategically strong position in the niche, high-margin segments of the pharmaceutical industry. Its specialized portfolio, regulatory agility, and patient-focused innovation, coupled with growth through M&A, position it well against larger competitors. However, ongoing challenges include scale limitations, regulatory risks, and supply chain dependencies. Strategic diversification, operational agility, and increased pipeline investment are pivotal for sustaining growth and capturing emerging opportunities in personalized medicine and rare disease therapeutics.

---

Key Takeaways

• Azurity’s focus on complex formulations positions it in high-demand, low-competition niches.
• The company’s strengths lie in regulatory expertise, patient-centric innovations, and strategic acquisitions.
• Growth opportunities exist in biologics, geographic expansion, and pipeline innovation.
• To maintain its competitive edge, Azurity must invest in R&D, diversify supply chains, and proactively engage with evolving regulatory landscapes.
• Larger competitors’ broad portfolios serve as both a challenge and an opportunity for Azurity to deepen specialization.

---

FAQs

1. How does Azurity differentiate itself from larger pharmaceutical companies?

Azurity specializes in complex, patient-specific formulations, offering tailored solutions in niche markets like rare diseases and oncology, contrasting with larger firms’ broad generic portfolios.

2. What are the main risks facing Azurity?

Key risks include dependence on niche markets susceptible to regulatory changes, supply chain disruptions, and limited scale affecting competitive pricing.

3. Which markets are critical for Azurity’s international expansion?

Europe via the EU market and emerging markets in Asia and Latin America present significant growth opportunities given regulatory harmonization and unmet medical needs.

4. How is Azurity leveraging innovation to grow?

Through increased R&D investments, strategic acquisitions, and partnerships focusing on biologics and personalized treatments, Azurity aims to expand its pipeline and market relevance.

5. What regulatory challenges could impact Azurity’s strategy?

Recent tightening of GMP standards, orphan drug regulations, and supply chain oversight could necessitate continuous compliance investments, impacting speed to market and profitability.

---

Sources:

[1] IBISWorld Industry Reports on Specialty & Generic Pharmaceutical Manufacturing (2022)
[2] Evaluate Pharma 2022, Specialty & Rare Disease Market Analysis
[3] Company disclosures and industry analyst insights (2022-2023)