Impax Company Profile

What is the competitive landscape for IMPAX

IMPAX has one hundred and fifty-three approved drugs.

There are twenty-four US patents protecting IMPAX drugs. There are four tentative approvals on IMPAX drugs.

There are fifty-six patent family members on IMPAX drugs in fourteen countries and one hundred and forty-seven supplementary protection certificates in sixteen countries.

Summary for Impax

International Patents:	56
US Patents:	24
Tradenames:	120
Ingredients:	116
NDAs:	153
Patent Litigation for Impax:	See patent lawsuits for Impax
PTAB Cases with Impax as petitioner:	See PTAB cases with Impax as petitioner

Drugs and US Patents for Impax

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-002	Aug 7, 2024		RX	Yes	No	10,292,935		Y
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-002	Aug 7, 2024		RX	Yes	No	12,201,596
Impax	CREXONT	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	217186-001	Aug 7, 2024		RX	Yes	No	10,973,769		Y
Impax Labs	DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride	CAPSULE;ORAL	080807-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Impax Labs Inc	SEVELAMER CARBONATE	sevelamer carbonate	TABLET;ORAL	090975-001	Oct 23, 2017		DISCN	No	No

Expired US Patents for Impax

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Impax	ADRENACLICK	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800-004	Nov 25, 2009	10,166,344
Impax	RYTARY	carbidopa; levodopa	CAPSULE, EXTENDED RELEASE;ORAL	203312-001	Jan 7, 2015	7,094,427
Impax	TWINJECT 0.15	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800-002	May 28, 2004	7,621,891
Impax	TWINJECT 0.15	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800-002	May 28, 2004	7,297,136
Impax	TWINJECT 0.3	epinephrine	INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS	020800-001	May 30, 2003	7,297,136

Paragraph IV (Patent) Challenges for IMPAX drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Extended-release Capsules	23.75 mg/95 mg, 36.25 mg/145 mg, 48.75 mg/195 mg		2015-06-24
	Extended-release Capsules	61.25 mg/245 mg		2015-06-10
	Delayed-release Tablets	20 mg		2015-06-03

International Patents for Impax Drugs

Country	Patent Number	Estimated Expiration
Australia	2021282393
Japan	6033373
Mexico	369315
Poland	3054929
South Korea	101451564

Supplementary Protection Certificates for Impax Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2712622	122017000006	Germany		PRODUCT NAME: DESMOPRESSIN ODER DAS ACETAT DAVON; NAT. REGISTRATION NO/DATE: 94725.00.00 94726.00.00 20160901 FIRST REGISTRATION: BELGIEN BE497271 BE497280 20160504
2316456	300918	Netherlands		PRODUCT NAME: NALTREXON OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER NALTREXONHYDROCHLORIDE, EN BUPROPION OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER BUPROPIONHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/14/988 20150330
1532149	CA 2013 00001	Denmark		PRODUCT NAME: 8-(3-AMINOPIPERIDIN-1-YL)-7-BUT-2-INYL-3-METHYL-1-(4-METHYLCHINAZOLIN-2-YLMETHYL)-3,7-DIHYDROPURIN-2,6-DION ENANTIOMERER OG SALTE DERAF - SAERLIGT LINAGLIPTIN - I KOMBINATION MED METFORMINHYDROCHLORID; REG. NO/DATE: EU/1/12/780/001-028 20120720
1532149	PA2012022	Lithuania		PRODUCT NAME: LINAGLIPTINUM + METFORMINI HYDROCHLORIDUM; REGISTRATION NO/DATE: EU/1/12/780/001 - EU/1/12/780/034 20120720
0124495	SPC/GB01/006	United Kingdom		PRODUCT NAME: ESOMEPRAZOLE AS MAGNESIUM TRIHYDRATE; REGISTERED: SE 15945 20000310; SE 15946 20000310; UK PL 17901/0068-0069 20000727

Similar Applicant Names

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

• Impax
• Impax Labs
• Impax Labs Inc
• Impax Pharms

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

In the dynamic world of pharmaceuticals, understanding the competitive landscape is crucial for success. This article delves into the market position, strengths, and strategic insights of Impax Laboratories, a key player in the pharmaceutical industry. We'll explore how Impax navigates the complex pharmaceutical market and positions itself against competitors.

Impax Laboratories: Company Overview

Impax Laboratories, Inc. is a specialty pharmaceutical company that focuses on developing, manufacturing, and marketing bioequivalent pharmaceutical products[1]. Founded in 1993 and headquartered in Hayward, California, Impax has established itself as a significant player in the pharmaceutical industry, particularly in the generic drug market[4].

The company operates through two main divisions:

1. Global Pharmaceuticals Division: Produces generic bioequivalent products
2. Impax Division: Focuses on branded internally produced products, specializing in neurology and Central Nervous System (CNS) disorders[1]

Market Position and Strategic Alliances

Impax has carved out a unique position in the pharmaceutical market by focusing on technologically advanced controlled-release drug products. This specialization has allowed the company to compete effectively with larger pharmaceutical giants while maintaining a niche in the market[1].

"Impax has a strategic alliance agreement with Teva Pharmaceuticals USA, Inc. to develop, manufacture, and distribute controlled release generic pharmaceutical products."[4]

This strategic alliance with Teva, one of the largest generic drug manufacturers globally, significantly enhances Impax's market position and distribution capabilities.

Strengths and Competitive Advantages

1. Technological Expertise

Impax's focus on controlled-release drug delivery technology sets it apart from many competitors. This expertise allows the company to develop products with unique drug delivery mechanisms, targeting specific parts of the body at certain times and in specific dosages[1].

2. Diverse Product Portfolio

As of 2010, Impax's Global division manufactured 102 products with 79 under development and 39 pending Abbreviated New Drug Applications (ANDAs)[1]. This diverse pipeline provides multiple revenue streams and mitigates risk.

3. Strong Industry Recognition

Impax has gained significant industry recognition, with major clients including pharmaceutical giants such as McKesson Corporation, Cardinal Health, and Amerisource-Bergen[1]. This recognition not only provides stable revenue but also enhances the company's reputation in the industry.

4. Focus on High-Margin Opportunities

The company strategically targets first-to-file and first-to-market opportunities, which often come with higher profit margins[1]. This approach allows Impax to maximize returns on its investments in research and development.

Strategic Insights and Future Directions

Expansion into Branded Products

In 2006, Impax launched its branded products division, focusing on neurology and CNS disorders. This move into the branded market represents a strategic shift to diversify revenue streams and potentially capture higher margins[1].

International Expansion

Impax has shown a clear intent to expand its global footprint. The company completed a manufacturing facility in Taiwan in 2010, with plans to double its capacity[1]. This expansion into international markets could provide significant growth opportunities.

Focus on Central Nervous System (CNS) Market

The company's strategic focus on the CNS market is particularly noteworthy. In 2010, the CNS market accounted for $77 billion in prescriptions, constituting 21% of the $367 billion pharmaceutical market[1]. With major CNS market participants facing patent expirations in 2012-2013, Impax positioned itself to capitalize on this opportunity.

Competitive Landscape

While Impax has carved out a strong position, it faces significant competition in the pharmaceutical industry. Key competitors include:

1. Teva Pharmaceutical Industries, Ltd.
2. Mylan, Inc.
3. Lannett Company, Inc.
4. Zydus Pharmaceuticals USA Inc.
5. Watson Pharmaceuticals, Inc.[1]

These companies compete with Impax in various therapeutic areas and market segments, particularly in the generic drug market.

Challenges and Opportunities

Challenges

1. Dependency on Key Clients: A significant portion of Impax's revenue comes from a small number of large clients, which could pose a risk if these relationships were to change[1].

2. Regulatory Hurdles: Like all pharmaceutical companies, Impax faces stringent regulatory requirements, which can impact product approvals and market entry timelines.

3. Competition in Generic Market: The generic drug market is highly competitive, with constant pressure on pricing and the need for continuous innovation.

Opportunities

1. Patent Expirations: The upcoming patent expirations of several major CNS drugs present a significant opportunity for Impax's generic division[1].

2. Growth in CNS Market: The continued growth of the CNS market aligns well with Impax's strategic focus[1].

3. International Expansion: The company's efforts to expand internationally, particularly in Asia, could open up new markets and growth opportunities[1].

Financial Performance and Market Trends

Impax has shown strong financial performance, with significant growth in revenues from 2005 to 2010[1]. However, it's important to note that the pharmaceutical market can be volatile, with performance often tied to successful product launches and regulatory approvals.

The company's stock performance has generally outpaced market indices and industry peers, indicating investor confidence in Impax's strategy and execution[1].

Future Outlook

Impax's future outlook appears promising, driven by several factors:

1. Robust Pipeline: With numerous products under development and pending approvals, Impax is well-positioned for future growth[1].

2. Strategic Focus: The company's focus on high-margin opportunities and the growing CNS market aligns well with industry trends[1].

3. Expansion Plans: Impax's plans for international expansion and increased production capacity suggest confidence in future demand for its products[1].

4. Partnerships: Strategic alliances, such as the one with GlaxoSmithKline for the development and commercialization of IPX066 (a Parkinson's Disease treatment), provide additional avenues for growth[2].

Key Takeaways

1. Impax Laboratories has established a strong position in the pharmaceutical market, particularly in generic drugs and CNS treatments.
2. The company's focus on controlled-release technology and high-margin opportunities provides a competitive advantage.
3. Impax faces challenges from larger competitors but has opportunities for growth through international expansion and strategic partnerships.
4. The company's diverse product portfolio and robust pipeline position it well for future growth.
5. Impax's strategic focus on the CNS market aligns with industry trends and upcoming patent expirations.

FAQs

1. Q: What are Impax Laboratories' main business divisions? A: Impax operates through two main divisions: the Global Pharmaceuticals Division, which produces generic bioequivalent products, and the Impax Division, which focuses on branded internally produced products, specializing in neurology and CNS disorders.

2. Q: How does Impax differentiate itself from competitors? A: Impax differentiates itself through its focus on technologically advanced controlled-release drug products and its specialization in the CNS market.

3. Q: What are some of Impax's key strategic partnerships? A: Impax has strategic alliances with companies like Teva Pharmaceuticals USA for generic drug development and distribution, and GlaxoSmithKline for the development and commercialization of specific products like IPX066.

4. Q: What are the main growth opportunities for Impax? A: Key growth opportunities include international expansion, particularly in Asia, capitalizing on upcoming patent expirations in the CNS market, and leveraging its robust product pipeline.

5. Q: How has Impax's financial performance compared to the broader market? A: Impax has generally outperformed market indices and industry peers in terms of stock performance, indicating strong investor confidence in the company's strategy and execution.

Sources cited:

1. https://www.stjohns.edu/sites/default/files/uploads/SMIF%20UG%20Impax%20Laboratories.pdf
2. https://www.gsk.com/en-gb/media/press-releases/glaxosmithkline-and-impax-pharmaceuticals-enter-global-agreement-to-develop-and-commercialise-a-late-stage-compound-for-parkinson-s-disease/
3. https://www.bourne-partners.com/deal-profile/deal-profile-amneal-pharmaceuticals-impax-laboratories/