Zyla Company Profile

What is the competitive landscape for ZYLA

ZYLA has eight approved drugs.

There are ten US patents protecting ZYLA drugs.

There are sixty-eight patent family members on ZYLA drugs in twenty-four countries and ten supplementary protection certificates in eight countries.

Summary for Zyla

International Patents:	68
US Patents:	10
Tradenames:	6
Ingredients:	5
NDAs:	8

Drugs and US Patents for Zyla

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Zyla	ARYMO ER	morphine sulfate	TABLET, EXTENDED RELEASE;ORAL	208603-002	Jan 9, 2017		DISCN	Yes	No	9,549,899		Y
Zyla	INDOCIN	indomethacin	SUSPENSION;ORAL	018332-001	Oct 10, 1985	AB	RX	Yes	Yes
Zyla Life Sciences	INDOCIN	indomethacin	CAPSULE;ORAL	016059-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Zyla	INDOCIN SR	indomethacin	CAPSULE, EXTENDED RELEASE;ORAL	018185-001	Feb 23, 1982		DISCN	Yes	No
Zyla	ZORVOLEX	diclofenac	CAPSULE;ORAL	204592-001	Oct 18, 2013		DISCN	Yes	No	8,679,544		Y

Expired US Patents for Zyla

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Zyla Life Sciences	INDOCIN	indomethacin	SUPPOSITORY;RECTAL	017814-001	Aug 13, 1984	3,644,630
Zyla	INDOCIN SR	indomethacin	CAPSULE, EXTENDED RELEASE;ORAL	018185-001	Feb 23, 1982	4,173,626
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-002	Jun 17, 2011	7,981,439
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-002	Jun 17, 2011	7,201,920
Zyla	OXAYDO	oxycodone hydrochloride	TABLET;ORAL	202080-002	Jun 17, 2011	8,409,616

Paragraph IV (Patent) Challenges for ZYLA drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Capsules	18 mg and 35 mg		2014-06-06
	Extended-release Tablets	15 mg, 30 mg and 60 mg		2017-12-29
	Nasal Spray	15.75 mg/spray		2012-03-12

International Patents for Zyla Drugs

Country	Patent Number	Estimated Expiration
African Regional IP Organization (ARIPO)	3774
Israel	215869
Japan	6154846
Mexico	337619
Spain	2637338

Supplementary Protection Certificates for Zyla Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1534313	15C0090	France		PRODUCT NAME: SOLUTION D'IRRIGATION OCULAIRE COMPRENANT DE LA PHENYLEPHRINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DU KETOROLAC OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1534313	2015/071	Ireland		PRODUCT NAME: AN OCULAR IRRIGATION SOLUTION COMPRISING PHENYLEPHRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND KETOROLAC OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/15/1018 20150728
1685839	92292	Luxembourg		PRODUCT NAME: COMBINAISON D OXYCODONE EN TANT QUE COMPOSANT A ET DE NALOXONE EN TANT QUE COMPOSANT B SOUS TOUTES LES FORMES PROTEGES PAR LE BREVET DE BASE
1534313	C 2015 055	Romania		PRODUCT NAME: COMBINATIE DE FENILEFRINA SAU O SARE ACCEPTABILAFARMACEUTIC A ACESTEIA SI KETOROLAC SATIONAL AUTHORISATION: 20150728; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/15/1018; DATE OF FIRST AUTHORISATION IN EEA: 20150728 U O SARE ACCEPTABILA FARMACEUTIC AACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/15/1018; DATE OF NA
1534313	CR 2015 00072	Denmark		PRODUCT NAME: PHENYLEPHRIN, HERUNDER PHENYLEPHRINHYDROCHLORID OG KETOROLAC, HERUNDER KETOROLACTROMETAMOL; REG. NO/DATE: EU/1/15/1018 20150730

Similar Applicant Names

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

• Zyla
• Zyla Life Sciences

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

In the dynamic world of pharmaceuticals, understanding the competitive landscape is crucial for success. Zyla Life Sciences, a specialty pharmaceutical company, has carved out a niche for itself in the pain management sector. This comprehensive analysis delves into Zyla's market position, strengths, and strategic insights, providing valuable information for industry professionals and investors alike.

Zyla Life Sciences: Company Overview

Zyla Life Sciences, formerly known as Egalet Corporation, is a specialty pharmaceutical company focused on developing, manufacturing, and commercializing treatments for pain and other conditions[1]. The company's product portfolio includes several FDA-approved medications, positioning it as a significant player in the pain management market.

Key Products and Focus Areas

Zyla's product lineup includes:

1. SPRIX® (ketorolac tromethamine) Nasal Spray
2. VIVLODEX® (meloxicam)
3. ZORVOLEX® (diclofenac)
4. INDOCIN® (indomethacin) suppositories and oral suspension
5. OXAYDO® (oxycodone HCI, USP) tablets

These products primarily target pain management, with a focus on non-steroidal anti-inflammatory drugs (NSAIDs) and opioid medications[1][5].

Market Position and Financial Performance

Zyla Life Sciences has shown significant growth in recent years. In 2019, the company reported net product sales of $81.3 million, more than doubling its performance from the previous year[5]. This growth demonstrates Zyla's strengthening position in the pharmaceutical market.

Revenue Breakdown

The company's sales are primarily generated in the United States, as shown in the following table:

Fiscal Period: December	2018	2019
United States	$30.35M	$81.3M

This significant increase in revenue indicates Zyla's successful market penetration and growing acceptance of its products among healthcare providers and patients[1].

Competitive Advantages and Strengths

Zyla Life Sciences possesses several key strengths that contribute to its competitive edge in the pharmaceutical industry:

1. Diverse Product Portfolio

Zyla's range of pain management products allows it to cater to various patient needs and market segments. This diversification helps mitigate risks associated with reliance on a single product.

2. Focus on Abuse-Deterrent Formulations

The company has developed proprietary technologies, such as Guardian Technology, to create abuse-deterrent formulations of opioid medications. This focus addresses a critical concern in pain management and aligns with regulatory efforts to combat opioid abuse[1].

3. Strong R&D Pipeline

Zyla continues to invest in research and development, with late-stage product candidates like ARYMO ER and Egalet-002 in the pipeline. This commitment to innovation positions the company for future growth and market expansion[1].

4. Experienced Leadership Team

The company boasts a management team with extensive experience in the pharmaceutical industry. Key figures like Todd Smith (CEO) and Daniel Peisert (CFO) bring valuable expertise to guide Zyla's strategic direction[1].

Competitive Landscape and Market Trends

The analgesics market, in which Zyla operates, is highly competitive and rapidly evolving. Understanding the broader landscape is crucial for assessing Zyla's position and potential for growth.

Market Size and Growth Projections

The global analgesics market was valued at $53.72 billion in 2023 and is projected to reach $77.52 billion by 2031, growing at a CAGR of 4.69%[4]. This growth is driven by factors such as an aging population, increasing prevalence of chronic pain conditions, and advancements in drug delivery technologies.

Key Competitors

While specific competitors are not mentioned in the provided search results, it's important to note that the analgesics market includes major pharmaceutical companies as well as specialty players like Zyla. Competition likely comes from both established pain management portfolios and new entrants with innovative formulations.

Emerging Trends

Several trends are shaping the pharmaceutical landscape, particularly in pain management:

1. Shift towards non-opioid pain solutions
2. Increasing focus on abuse-deterrent formulations
3. Growing demand for personalized medicine
4. Rise of telemedicine and digital health solutions

Zyla's product portfolio and R&D focus align well with these trends, particularly in the areas of non-opioid NSAIDs and abuse-deterrent opioid formulations.

Strategic Moves and Future Outlook

To strengthen its market position and drive growth, Zyla has made several strategic moves:

Merger with Assertio Therapeutics

In March 2020, Zyla announced a merger with Assertio Therapeutics, creating a combined company with a stronger portfolio of neurology and non-opioid pain products[10]. This merger is expected to:

• Create synergies and cost savings
• Enhance the combined company's financial strength
• Position the new entity for future acquisitions and partnerships

"We believe the merger of Zyla and Assertio will create a stronger company with a robust differentiated portfolio," said Mr. Smith, CEO of Zyla Life Sciences[10].

Focus on Commercial Excellence

Zyla has emphasized commercial excellence as a key driver of growth. The company has successfully expanded its product portfolio and doubled its net product sales in a single year, demonstrating effective commercial strategies[5].

Potential for Future Acquisitions

With the improved financial position resulting from the Assertio merger, Zyla is well-positioned to pursue strategic acquisitions to further expand its product offerings and market reach[10].

Challenges and Risks

Despite its strengths and strategic positioning, Zyla faces several challenges in the competitive pharmaceutical landscape:

1. Regulatory Environment: The pain management sector, particularly opioids, faces intense regulatory scrutiny.
2. Market Competition: Large pharmaceutical companies with significant resources compete in the pain management space.
3. Pricing Pressures: Increasing focus on healthcare costs may impact pricing strategies.
4. Opioid Crisis: Public perception and regulatory responses to the opioid epidemic could affect certain product lines.

Implications for Stakeholders

For investors, healthcare providers, and industry professionals, Zyla's position in the market offers several key insights:

1. Growth Potential: Zyla's recent financial performance and strategic moves suggest potential for continued growth.
2. Innovation Focus: The company's emphasis on abuse-deterrent formulations aligns with important industry trends.
3. Diversification: Zyla's product portfolio spans both opioid and non-opioid pain solutions, providing some insulation against market shifts.
4. Consolidation Trend: The merger with Assertio reflects broader industry trends towards consolidation to achieve scale and synergies.

Key Takeaways

• Zyla Life Sciences has established a strong position in the pain management market with a diverse product portfolio.
• The company's focus on abuse-deterrent formulations and non-opioid solutions aligns well with current market trends.
• Significant revenue growth and strategic moves, such as the merger with Assertio, position Zyla for future expansion.
• Challenges remain, including regulatory pressures and intense market competition.
• Zyla's success demonstrates the potential for specialized pharmaceutical companies to carve out significant market share in targeted therapeutic areas.

FAQs

1. Q: What is Zyla Life Sciences' primary focus in the pharmaceutical industry? A: Zyla Life Sciences primarily focuses on developing, manufacturing, and commercializing treatments for pain management, including both opioid and non-opioid medications.

2. Q: How has Zyla's financial performance changed in recent years? A: Zyla's net product sales more than doubled from 2018 to 2019, reaching $81.3 million in 2019.

3. Q: What is the significance of Zyla's merger with Assertio Therapeutics? A: The merger is expected to create a stronger company with a more diverse product portfolio, improved financial strength, and better positioning for future growth and acquisitions.

4. Q: What are some of Zyla's key competitive advantages? A: Zyla's competitive advantages include a diverse product portfolio, focus on abuse-deterrent formulations, strong R&D pipeline, and experienced leadership team.

5. Q: What are the main challenges facing Zyla in the current pharmaceutical landscape? A: Key challenges include regulatory pressures, intense market competition, pricing pressures, and navigating the complexities of the opioid crisis.

Sources cited: [1] https://www.marketscreener.com/quote/stock/ZYLA-LIFE-SCIENCES-46288930/company/ [4] https://www.databridgemarketresearch.com/reports/global-analgesics-market [5] https://www.biospace.com/zyla-life-sciences-reports-fourth-quarter-and-full-year-2019-financial-results [10] https://www.biospace.com/assertio-therapeutics-agrees-to-merge-with-zyla-life-sciences-to-create-synergistic-portfolio-of-neurology-and-non-opioid-pain-products