Mylan Company Profile

What is the competitive landscape for MYLAN

MYLAN has three hundred and ninety-six approved drugs.

There are thirty-five US patents protecting MYLAN drugs. There are forty-two tentative approvals on MYLAN drugs.

There are two hundred and seventeen patent family members on MYLAN drugs in thirty-nine countries and nine hundred and three supplementary protection certificates in eighteen countries.

Summary for Mylan

International Patents:	217
US Patents:	35
Tradenames:	326
Ingredients:	300
NDAs:	396
Patent Litigation for Mylan:	See patent lawsuits for Mylan
PTAB Cases with Mylan as petitioner:	See PTAB cases with Mylan as petitioner

Drugs and US Patents for Mylan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan	AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM	amlodipine besylate; atorvastatin calcium	TABLET;ORAL	200465-006	Nov 29, 2013	AB	RX	No	No
Mylan Pharms Inc	ARMODAFINIL	armodafinil	TABLET;ORAL	200043-004	May 9, 2019	AB	RX	No	No
Mylan	FELODIPINE	felodipine	TABLET, EXTENDED RELEASE;ORAL	078855-002	Apr 17, 2008		DISCN	No	No
Mylan Asi	GRANISETRON HYDROCHLORIDE	granisetron hydrochloride	INJECTABLE;INJECTION	091137-002	Apr 9, 2010	AP	RX	No	No
Mylan	LINACLOTIDE	linaclotide	CAPSULE;ORAL	209564-002	Feb 9, 2021		DISCN	No	No
Mylan Labs Ltd	NALOXONE HYDROCHLORIDE	naloxone hydrochloride	INJECTABLE;INJECTION	213843-001	Jun 9, 2022	AP	RX	No	No

Expired US Patents for Mylan

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan Pharms Inc	AVITA	tretinoin	CREAM;TOPICAL	020404-003	Jan 14, 1997	5,045,317
Mylan	DENAVIR	penciclovir	CREAM;TOPICAL	020629-001	Sep 24, 1996	6,579,981
Mylan Speciality Lp	DYMISTA	azelastine hydrochloride; fluticasone propionate	SPRAY, METERED;NASAL	202236-001	May 1, 2012	8,163,723*PED
Mylan Speciality Lp	MUSE	alprostadil	SUPPOSITORY;URETHRAL	020700-002	Nov 19, 1996	5,242,391
Mylan Speciality Lp	TOBI	tobramycin	SOLUTION;INHALATION	050753-001	Dec 22, 1997	5,508,269
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018	10,343,995

Paragraph IV (Patent) Challenges for MYLAN drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	for Injection	1 mg/vial, 2 mg/vial and 5 mg/vial		2013-12-27
	Injection (Auto-injector)	0.15 mg/0.3 mL and 0.3 mg/0.3 mL		2008-11-21
	Nasal Spray	137 mcg/50 mcg per spray		2014-06-13
	CapsulesInhalation Solution	0.02 mg/2 mL		2009-01-21
	for Injection	200 mcg/vial		2015-05-01
	Injection	1 mg/mL, 50 mL vials		2011-12-16
	Injection (Auto-injector)	0.15 mg/0.3 mL and 0.3 mg/0.3 mL		2008-11-21
	Inhalation Solution	300 mg/5 mL		2009-06-29
	Sublingual Tablets	5 mg and 10 mg		2010-04-29
	for Injection	100 mcg/vial and 500 mcg/vial		2015-04-14
	Injection	100 mg/mL, 2.5 mL vials		2007-09-24

International Patents for Mylan Drugs

Country	Patent Number	Estimated Expiration
Denmark	2075000
Denmark	1723114
Hungary	E026950
Japan	4542090
Mexico	2012000682
Singapore	178036

Supplementary Protection Certificates for Mylan Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2217577	122019000008	Germany		PRODUCT NAME: DUZALLO - ALLOPURINOL / LESINURAD ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER VERTRAEGLICHE SALZE DAVON; REGISTRATION NO/DATE: EU/1/18/1300 20180823
0663916	14/2004	Austria		PRODUCT NAME: EVEROLIMUS (40-0-(2-HYDROXY)ETYHL RAPAMYCIN); NAT. REGISTRATION NO/DATE: 1-25271;1-25272; 1-25275,1-25276. 20040302; FIRST REGISTRATION: SE 18690;18691;18692; 18693;18694;18695. 20030718
1506211	92496	Luxembourg		PRODUCT NAME: COMBINAISON DE DAPAGLIFLOZINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DE METFORMINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,TELLE QUE PROTEGEE PAR LE BREVET DE BASE EP1506211 B1
2049506	92864	Luxembourg		PRODUCT NAME: COBICISTAT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/13/830/001-002 20130527
0287150	96C0038	Belgium		PRODUCT NAME: ROCURONIUMBROMIDE; NAT. REGISTRATION NO/DATE: 63 IS 9 F 12 19960709; FIRST REGISTRATION: NL RVG 16946 19940406
1441735	SPC/GB08/020	United Kingdom		PRODUCT NAME: RALTEGRAVIR OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT; REGISTERED: UK EU/1/07/436/001 20080102

Similar Applicant Names

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

• Mylan
• Mylan Asi
• Mylan Institutional
• Mylan Ireland Ltd
• Mylan Labs Ltd
• Mylan Pharms Inc

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

In the ever-evolving pharmaceutical industry, Mylan has established itself as a formidable player, known for its extensive portfolio of generic and specialty pharmaceuticals. This comprehensive analysis delves into Mylan's market position, strengths, and strategic insights, providing valuable information for industry professionals and investors alike.

Mylan's Global Presence and Market Share

Mylan has built a robust global presence, operating in over 165 countries and territories worldwide. This extensive reach has positioned the company as one of the leading generic and specialty pharmaceutical companies globally.

U.S. Market Dominance

In the United States, Mylan has secured a significant market share in the generic pharmaceutical sector. The company's strong presence is evident in the fact that one in every 11 prescriptions dispensed in the U.S. is a Mylan product[1]. This remarkable statistic underscores Mylan's dominant position in the world's largest pharmaceutical market.

Australian and New Zealand Markets

Mylan's market leadership extends beyond the U.S., with the company holding the highest market share in both the Australian and New Zealand generic pharmaceuticals markets. In Australia, Mylan's wholly-owned subsidiary Alphapharm boasts an impressive 47% market share by volume, offering a portfolio of approximately 170 products across 440 dosage strengths[1].

European and Asia Pacific Presence

The company has also established strong footholds in several key European and Asia Pacific markets. Mylan's leadership positions in France and Australia, coupled with its significant presence in other regions, contribute to its global market strength[1].

Mylan's Product Portfolio and Pipeline

Mylan's success is largely attributed to its diverse and extensive product portfolio, which spans various therapeutic areas and dosage forms.

Diverse Product Offerings

The company markets a global portfolio of approximately 1,100 different products, covering a wide array of therapeutic categories. Mylan's product range includes oral solids, topicals, liquids, and semi-solids, catering to diverse patient needs[1].

Specialty Formulations

Mylan has strategically focused on developing and manufacturing products that are challenging to formulate and typically have longer product life cycles. These include:

• Transdermal patches
• High potency formulations
• Injectables
• Controlled-release products
• Respiratory delivery products

This focus on complex formulations provides Mylan with a competitive edge and helps maintain its market position[1].

Robust Pipeline

Mylan boasts one of the industry's deepest pipelines, with a significant number of products pending regulatory approval. This robust pipeline positions the company for future growth and market expansion[1].

Mylan's Key Strengths and Competitive Advantages

Several factors contribute to Mylan's strong market position and competitive edge in the pharmaceutical industry.

Vertically Integrated Operations

Mylan operates one of the world's largest vertically integrated active pharmaceutical ingredient (API) operations. This integration provides substantial operational efficiencies and economies of scale, allowing the company to maintain cost-effectiveness and quality control throughout its supply chain[1].

Research and Development Capabilities

The company consistently invests in research and development to innovate and improve its offerings. This commitment to R&D enables Mylan to develop breakthrough treatments and address unmet medical needs, further strengthening its market position[2].

Quality and Regulatory Compliance

Mylan's dedication to maintaining the highest standards of quality is evident in its adherence to rigorous regulatory standards. The company's focus on quality assurance instills confidence in patients and healthcare providers, enhancing its reputation in the market[2].

Strategic Acquisitions and Partnerships

Mylan has strategically expanded its operations through acquisitions and partnerships. Notable acquisitions include:

• Mylan Laboratories Limited (formerly Matrix Laboratories Limited)
• Merck KGaA's generics and specialty pharmaceutical business
• Bioniche Pharma Holdings Limited

These strategic moves have strengthened Mylan's global presence and expanded its product portfolio[1].

Mylan's Market Strategies and Future Outlook

To maintain and enhance its market position, Mylan employs several key strategies and focuses on emerging opportunities.

Focus on Biosimilars

The biosimilars market presents a significant growth opportunity for Mylan. As patents for biologic drugs expire, there is increasing demand for more affordable biosimilar alternatives. Mylan is leveraging its expertise in generics to develop and commercialize biosimilar products, aiming to gain a competitive advantage in this emerging market segment[2].

Expansion in Emerging Markets

Mylan is actively pursuing growth opportunities in emerging markets, particularly in Latin America and Southeast Asia. The company is targeting high-demand therapeutic areas such as infectious diseases and cardiovascular conditions in these regions[4].

"Mylan plans to expand its generics portfolio into Latin America and Southeast Asia, targeting high-demand therapeutic areas such as infectious diseases and cardiovascular conditions. The company is negotiating regulatory approvals in Brazil, Mexico, and India and expects to launch five new generics in these regions within the next two years."[4]

Continued Focus on Complex Generics

Mylan continues to prioritize the development of complex generic products, which typically face less competition and offer higher profit margins. This strategy aligns with the company's strengths in formulation and manufacturing capabilities[2].

Challenges and Threats in the Competitive Landscape

Despite its strong market position, Mylan faces several challenges and threats in the highly competitive pharmaceutical industry.

Intense Competition

The pharmaceutical industry is characterized by fierce competition from both generic and branded pharmaceutical companies. This competitive landscape can impact Mylan's pricing power, market share, and profitability[2].

Price Erosion in Generic Markets

One of the major challenges for Mylan is the ongoing price erosion in the generic drug market. Increasing competition, regulatory changes, and pricing pressures from payers and governments can lead to lower prices for Mylan's generic products, potentially affecting its revenue and profitability[2].

Patent Expirations and Market Exclusivity

The expiration of patents for key branded drugs can pose both opportunities and threats to Mylan's generic business. While it opens up new market opportunities, it also increases competition as multiple generic versions enter the market[2].

Regulatory and Political Uncertainties

The pharmaceutical industry is subject to frequent regulatory changes and political uncertainties. Shifts in government policies, changes in healthcare regulations, or pricing reforms can significantly impact Mylan's operations, pricing strategies, and profitability[2].

Mylan's Competitive Positioning Against Key Rivals

To fully understand Mylan's market position, it's essential to consider its standing relative to key competitors in the pharmaceutical industry.

Teva Pharmaceutical Industries Ltd.

Teva is one of Mylan's primary competitors in the generic pharmaceutical space. Both companies have a strong global presence and extensive generic portfolios. However, Mylan's focus on complex generics and biosimilars differentiates it from Teva[2].

Pfizer Inc.

While Pfizer is primarily known for its branded pharmaceuticals, its Upjohn division competes with Mylan in the generics market. Mylan's recent merger with Pfizer's Upjohn business to form Viatris has reshaped the competitive landscape[5].

Novartis AG (Sandoz)

Novartis's generics division, Sandoz, is another major competitor for Mylan. Both companies have strong positions in the U.S. and European markets and are actively pursuing opportunities in biosimilars[2][8].

Mylan's Corporate Social Responsibility and Sustainability Efforts

Mylan's commitment to corporate social responsibility and sustainability plays a crucial role in its market positioning and public perception.

Access to Medicine

Mylan has made significant strides in improving global access to medicine. The company delivers approximately 62 billion doses of medicine across more than 165 countries and territories, including 90% of low- and lower-middle-income countries[9].

HIV/AIDS Treatment

Mylan plays a crucial role in global HIV/AIDS treatment, providing medication to approximately 60% of the world's HIV+ children receiving treatment[9].

Environmental Sustainability

The company has demonstrated a commitment to environmental sustainability, growing its renewable energy consumption by 25% in recent years[9].

Key Takeaways

• Mylan holds a strong global market position, particularly in the U.S., Australia, and New Zealand generic pharmaceutical markets.
• The company's diverse product portfolio, focus on complex generics, and robust pipeline contribute to its competitive advantage.
• Mylan's vertically integrated operations and strategic acquisitions have strengthened its market position.
• The company faces challenges including intense competition, price erosion, and regulatory uncertainties.
• Mylan's focus on biosimilars and expansion in emerging markets present significant growth opportunities.
• The company's commitment to corporate social responsibility and sustainability enhances its market reputation.

FAQs

1. What is Mylan's market share in the U.S. generic pharmaceutical market? Mylan has a significant presence in the U.S. market, with one in every 11 prescriptions dispensed being a Mylan product.

2. How does Mylan's product portfolio differ from its competitors? Mylan focuses on complex generics and specialty pharmaceuticals, including transdermal patches, high potency formulations, and respiratory delivery products.

3. What are Mylan's key growth strategies for the future? Mylan is focusing on biosimilars development, expansion in emerging markets, and continued investment in complex generic products.

4. How does Mylan contribute to global healthcare accessibility? Mylan delivers approximately 62 billion doses of medicine across more than 165 countries and territories, including 90% of low- and lower-middle-income countries.

5. What is Mylan's approach to environmental sustainability? Mylan has demonstrated a commitment to environmental sustainability, growing its renewable energy consumption by 25% in recent years.

Sources cited: [1] https://investor.mylan.com/static-files/290595fd-691c-4caa-b79e-aaabc8b7cd9c [2] https://pitchgrade.com/companies/mylan [4] https://umbrex.com/resources/industry-analyses/how-to-analyze-a-pharmaceutical-company/generics-portfolio-strength-and-market-share/ [5] https://investor.mylan.com/news-releases/news-release-details/mylan-and-pfizer-announce-viatris-new-company-name-planned-mylan [8] https://canvasbusinessmodel.com/blogs/competitors/sandoz-international-competitive-landscape [9] https://investor.mylan.com/news-releases/news-release-details/mylan-releases-legacy-impact-2019-global-social-responsibility