Endo Operations Company Profile

What is the competitive landscape for ENDO OPERATIONS

ENDO OPERATIONS has two hundred and twenty-one approved drugs.

There are thirty-one US patents protecting ENDO OPERATIONS drugs. There is one tentative approval on ENDO OPERATIONS drugs.

There are eighty-six patent family members on ENDO OPERATIONS drugs in thirty-nine countries and three hundred and fifty-four supplementary protection certificates in seventeen countries.

Summary for Endo Operations

International Patents:	86
US Patents:	31
Tradenames:	176
Ingredients:	155
NDAs:	221

Drugs and US Patents for Endo Operations

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Endo Operations	ALPRAZOLAM	alprazolam	TABLET, EXTENDED RELEASE;ORAL	078442-002	Oct 15, 2007		DISCN	No	No
Endo Operations	DELESTROGEN	estradiol valerate	INJECTABLE;INJECTION	009402-002	Approved Prior to Jan 1, 1982	AO	RX	Yes	Yes
Endo Operations	DEXMETHYLPHENIDATE HYDROCHLORIDE	dexmethylphenidate hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	202842-002	Nov 30, 2016	AB	RX	No	No
Endo Operations	GLYCOPYRROLATE	glycopyrrolate	TABLET;ORAL	040653-002	Aug 31, 2006	AA	RX	No	Yes
Endo Operations	RISPERIDONE	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	077494-005	Apr 30, 2009	AB	RX	No	No
Endo Operations	VASOSTRICT	vasopressin	SOLUTION;INTRAVENOUS	204485-003	Apr 15, 2020		RX	Yes	Yes	9,962,422

Expired US Patents for Endo Operations

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Endo Operations	DANTRIUM	dantrolene sodium	CAPSULE;ORAL	017443-002	Approved Prior to Jan 1, 1982	3,415,821
Endo Operations	MEGACE ES	megestrol acetate	SUSPENSION;ORAL	021778-001	Jul 5, 2005	9,101,549
Endo Operations	NASCOBAL	cyanocobalamin	SPRAY, METERED;NASAL	021642-001	Jan 31, 2005	7,879,349
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-004	Jun 22, 2006	5,958,456
Endo Operations	OPANA ER	oxymorphone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021610-001	Jun 22, 2006	5,662,933
Endo Operations	TESTIM	testosterone	GEL;TRANSDERMAL	021454-001	Oct 31, 2002	7,608,605

Paragraph IV (Patent) Challenges for ENDO OPERATIONS drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Gel	10 mg/actuation		2012-08-14
	Injection	100 mg/mL, 2.5 mL vials		2007-09-24
	Injection	250 mg/mL		2014-06-11
	for Injection	200 mcg/vial		2015-05-01
	Injection	20 units/mL, 1 mL		2018-03-23
	Extended-release Tablets	7.5 mg and 15 mg		2008-05-29
	Tablets	2.5 mg		2011-03-09
	Nasal Spray	500 mcg/spray		2017-04-28
	Gel	1%		2008-08-21
	Injection	1 mg/mL, 50 mL vials		2011-12-16
	for Injection	100 mcg/vial and 500 mcg/vial		2015-04-14
	Injection	1 mg/mL ampules		2016-03-09
	Extended-release Tablets	5 mg, 10 mg, 20 mg and 40 mg		2007-11-23
	Extended-release Tablets	30 mg		2008-06-12

International Patents for Endo Operations Drugs

Country	Patent Number	Estimated Expiration
Canada	3093725
Canada	2644095
European Patent Office	1487517
Israel	170473
Portugal	1457208
South Korea	20050109561

Supplementary Protection Certificates for Endo Operations Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1507558	12C0033	France		PRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: CH - 6167801 20110705
1713823	1490064-1	Sweden		PRODUCT NAME: SIMEPREVIR, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516
2822954	1890030-8	Sweden		PRODUCT NAME: BICTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR BICTEGRAVIR SODIUM; REG. NO/DATE: EU/1/18/1289 20180625
1746976	2017C/027	Belgium		PRODUCT NAME: LE SEL DE SUCROSOFATE D'IRINOTECAN, PAR EXEMPLE LE SEL DE SUCROSOFATE D'IRINOTECAN INCORPORE DANS UN LIPOSOME MODIFIE PAR PEGYLATION, TEL QU'UN LIPOSOME COMPRENANT DE LA 1,2-DISTEAROYL-SN- PHOSPHATIDYLCHOLINE, DU CHOLESTEROL ET DU N- (OMEGA-METHOXY POLY (ETHYLENE GLYCOL) (POIDS MOLECULAIRE 2000) -OXYCARBONYL)-1,2-DISEEAROYLPHOSPHATIDYLETHANOLAMINE, PAR EXEMPLE DANS DES RAPPORTS MOLAIRES 3: 2: 0,015; OU COMME DEMANDE AUXILIAIRE, IRINOTECAN; AUTHORISATION NUMBER AND DATE: EU/1/16/1130 20161018
2269603	CA 2015 00058	Denmark		PRODUCT NAME: EVEROLIMUS ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/09/538/001-008 (K(2012)5347) 20120725
1856135	LUC00153	Luxembourg		PRODUCT NAME: FOSTAMATINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE FOSTAMATINIB, OU UN HYDRATE, SOLVATE OU N-OXYDE DE FOSTAMATINIB OU LE SEL PHARMACEUTIQUEMENT ACCEPTABLE DE FOSTAMATINIB, EN PARTICULIER FOSTAMATINIB DISODIUM, EVENTUELLEMENT SOUS FORME D'HYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/19/1405 20200113

Similar Applicant Names

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

• Endo Operations
• Endo Pharms

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

Endo International plc, a specialty pharmaceutical company, has established itself as a significant player in the global pharmaceutical industry. With a focus on developing, manufacturing, and marketing both branded and generic pharmaceutical products, Endo has carved out a unique position in the market. This comprehensive analysis delves into Endo's operations, market position, strengths, and strategic insights to provide a clear picture of the company's competitive landscape.

Endo's Market Position

Endo International has strategically positioned itself as a leading global specialty pharmaceutical company with a rapidly growing generics business. The company's acquisition of Par Pharmaceutical in 2015 significantly enhanced its market position, placing it among the top five generics businesses in the United States as measured by sales[1].

Diverse Product Portfolio

Endo's product portfolio spans multiple therapeutic areas, including:

• Pain management
• Urology
• Orthopedics
• Endocrinology

This diversification allows Endo to address various medical needs and reduce its reliance on any single product line. The company's focus on niche markets with minimal competition enables it to maintain premium pricing and robust profit margins[4].

Revenue Streams

Endo's revenue is primarily driven by a combination of proprietary and generic drugs. Some of its well-known branded products include:

• PERCOCET®
• SUPPRELIN® LA

The company's generics division complements these branded offerings by producing cost-effective versions of popular drugs, appealing to both cost-sensitive consumers and healthcare providers[4].

Endo's Operational Strengths

Endo's competitive advantage stems from several key operational strengths that set it apart in the pharmaceutical landscape.

Manufacturing Excellence

Our global manufacturing network spans one million square feet and features a proven track record of operational excellence and strong compliance.[3]

Endo's manufacturing capabilities are a cornerstone of its operations. The company's extensive manufacturing network, spanning one million square feet, demonstrates its commitment to operational excellence and compliance with industry regulations[3].

Culture of Quality and Compliance

Endo maintains a strong focus on quality and compliance throughout its operations. This patient-first mindset drives the company's adherence to stringent manufacturing standards, ensuring consistent and reliable production that meets and exceeds industry regulations[3].

Differentiated Capabilities

With a century-strong manufacturing legacy, Endo has developed unique capabilities in overcoming technical challenges, creating high-quality medicines, and mastering its supply chain. This expertise enables the company to produce a diverse range of products, including:

• Difficult-to-formulate products
• Advanced delivery systems (e.g., vials, syringes, pre-filled syringes, IV bags)
• Large volume parenteral products
• Ophthalmic and otic semi-permeable containers
• Combination drug device products[3]

Strategic Insights

Endo's strategic approach to the pharmaceutical market is multifaceted, focusing on several key areas to maintain and enhance its competitive position.

Focus on Core Businesses

Endo has implemented a strategy to streamline its operations and focus on its core businesses. This approach includes:

1. Qualitest: Capitalizing on demand trends for differentiated controlled substances and liquids, and targeting low-risk, high-return opportunities in generics.

2. Branded Pharmaceuticals: Enhancing performance of organic growth drivers and increasing profitability from mature brands while investing in key late-stage pipeline opportunities.

3. American Medical Systems: Leveraging its leading position in urology to enhance demand for unique products and services in attractive growth markets[2].

R&D Investment

Endo remains committed to research and development across each business unit, with a particular focus on:

• Development capabilities
• Near-term revenue-generating assets

This strategic investment in R&D allows Endo to continually enhance its product portfolio and explore new market opportunities[2].

Strategic Acquisitions and Partnerships

Endo actively pursues accretive acquisitions that offer attractive cost synergies and enhance its strategic positioning. The company also identifies incremental growth opportunities through product licensing and development[2].

Market Challenges and Adaptation

Despite its strong position, Endo faces several challenges in the dynamic pharmaceutical landscape.

Debt Restructuring

In 2022, Endo faced significant financial challenges, with its stock falling below $1 as the company grappled with restructuring its $8 billion debt. This led to the company filing for Chapter 11 bankruptcy protection in August 2022, reaching a $6 billion deal with some of its creditors related to opioid litigation in the US[6].

Regulatory Environment

The pharmaceutical industry is subject to stringent regulatory requirements. Endo must navigate this complex landscape, adapting its strategies to comply with evolving regulations while maintaining its competitive edge.

Global Competition

As a global player, Endo faces competition not just in its home markets but around the world. This global nature adds layers of complexity due to different regulatory environments, cultural factors, and market dynamics[5].

Future Outlook and Strategic Direction

Despite facing challenges, Endo continues to adapt and evolve its strategies to maintain its competitive position in the pharmaceutical industry.

Technology Adoption and Innovation

Endo is actively working to optimize its technology investments to boost productivity. The company is using education sessions on Microsoft technology to empower its team members and modernize work practices[9].

Continuous Evolution and Growth

Endo maintains an innovative mindset that extends beyond medicine to influence its internal operations. The company recognizes that empowering its team members to find and embrace new, more productive ways to complete tasks can give it a competitive advantage in an increasingly connected world[9].

Focus on Specialty Medicines and Sterile Injectables

Moving forward, Endo is likely to continue its focus on specialty medicines and sterile injectables. The company aims to empower patients and build trust with specialists while partnering with hospitals and healthcare systems to reduce complexity through life-enhancing solutions[8].

Key Takeaways

1. Endo International has established itself as a leading global specialty pharmaceutical company with a strong position in the generics market.

2. The company's diverse product portfolio spans multiple therapeutic areas, allowing it to address various medical needs and maintain robust profit margins.

3. Endo's operational strengths include manufacturing excellence, a culture of quality and compliance, and differentiated capabilities in producing complex pharmaceutical products.

4. The company's strategic approach focuses on streamlining operations, investing in R&D, and pursuing strategic acquisitions and partnerships.

5. Despite facing challenges such as debt restructuring and a complex regulatory environment, Endo continues to adapt through technology adoption, innovation, and a focus on specialty medicines and sterile injectables.

FAQs

1. What are Endo's main revenue streams? Endo's revenue is primarily driven by a combination of proprietary branded drugs (such as PERCOCET® and SUPPRELIN® LA) and generic drugs produced by its generics division.

2. How has Endo positioned itself in the pharmaceutical market? Endo has positioned itself as a leading global specialty pharmaceutical company with a rapidly growing generics business, focusing on niche markets with minimal competition.

3. What are some of Endo's key operational strengths? Endo's key operational strengths include its extensive manufacturing network, culture of quality and compliance, and differentiated capabilities in producing complex pharmaceutical products.

4. How is Endo addressing its financial challenges? In 2022, Endo filed for Chapter 11 bankruptcy protection and reached a $6 billion deal with creditors to restructure its debt and address opioid litigation.

5. What is Endo's strategy for future growth? Endo's strategy for future growth includes focusing on core businesses, investing in R&D, pursuing strategic acquisitions and partnerships, and optimizing technology adoption and innovation.

Sources cited: [1] https://www.fiercepharma.com/pharma/endo-completes-acquisition-of-par-pharmaceutical-and-provides-financial-guidance [2] https://www.fiercepharma.com/pharma/endo-health-solutions-announces-actions-to-streamline-operations-and-expand-platform-for [3] https://www.endo.com/products-and-capabilities/manufacturing/ [4] https://www.alphaspread.com/security/lse/0y5f/investor-relations [5] https://www.drugpatentwatch.com/blog/the-importance-of-pharmaceutical-competitor-analysis/ [6] https://en.wikipedia.org/wiki/Endo_International [8] https://www.endo.com [9] https://www.microsoft.com/en/customers/story/1751265039068758745-endo-microsoft-365-pharmaceuticals-en-united-states