Genus Lifesciences Company Profile

What is the competitive landscape for GENUS LIFESCIENCES

GENUS LIFESCIENCES has ten approved drugs.

There are four US patents protecting GENUS LIFESCIENCES drugs.

There are nine patent family members on GENUS LIFESCIENCES drugs in eight countries and twelve supplementary protection certificates in six countries.

Summary for Genus Lifesciences

International Patents:	9
US Patents:	4
Tradenames:	8
Ingredients:	8
NDAs:	10

Drugs and US Patents for Genus Lifesciences

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Genus Lifesciences	HYDROMORPHONE HYDROCHLORIDE	hydromorphone hydrochloride	TABLET;ORAL	077471-001	Dec 9, 2009		DISCN	No	No
Genus Lifesciences	LEVOLET	levothyroxine sodium	TABLET;ORAL	021137-004	Jun 6, 2003	AB1,AB2,AB3,AB4	RX	No	No	10,231,931		Y
Genus Lifesciences	LEVOLET	levothyroxine sodium	TABLET;ORAL	021137-011	Jun 6, 2003	AB1,AB2,AB3,AB4	RX	No	No	10,406,108		Y
Genus Lifesciences	POTASSIUM CHLORIDE	potassium chloride	SOLUTION;ORAL	206814-001	Dec 22, 2014	AA	RX	Yes	No
Genus Lifesciences	POTASSIUM CHLORIDE	potassium chloride	SOLUTION;ORAL	206814-002	Dec 22, 2014	AA	RX	Yes	Yes

Expired US Patents for Genus Lifesciences

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-001	Sep 14, 2016	9,364,439
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-002	Sep 14, 2016	6,926,907
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-001	Sep 14, 2016	6,926,907
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-001	Sep 14, 2016	8,206,741
Genus Lifesciences	YOSPRALA	aspirin; omeprazole	TABLET, DELAYED RELEASE;ORAL	205103-002	Sep 14, 2016	9,364,439

Paragraph IV (Patent) Challenges for GENUS LIFESCIENCES drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Delayed-release Tablets	81 mg/40 mg		2016-10-14

International Patents for Genus Lifesciences Drugs

Country	Patent Number	Estimated Expiration
Brazil	112014016085
Canada	2860231
China	104519888
European Patent Office	2797600
World Intellectual Property Organization (WIPO)	2013101897

Supplementary Protection Certificates for Genus Lifesciences Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1441735	2008/010	Ireland		PRODUCT NAME: RALTEGRAVIR OR A PHARMECEUTICALLY ACCEPTABLE SALT THEREOF, ESPECIALLY THE POTASSIUM SALT; NAT AUTHORISTION NO/DATE: EU/1/07/436/001-002 20071220;
0480717	98C0025	Belgium		PRODUCT NAME: LOSARTAN POTASSIUM; HYDROCHLOROTHIAZIDE; NAT. REGISTRATION NO/DATE: NL 20 037 19950215; FIRST REGISTRATION: FR - NL 20 037 19950215
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
1718641	SPC/GB12/028	United Kingdom		PRODUCT NAME: AZILSARTAN MEDOXOMIL AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, INCLUDING THE POTASSIUM SALT; REGISTERED: UK EU/1/11/734/001-011 20111209
0253310	SPC/GB95/010	United Kingdom		PRODUCT NAME: 2-N-BUTYL-4-CHLORO-1-((2'-(1H-TETRAZOL-5-YL)BIPHENYL-4-YL) METHYL) -5-(HYDROXYMETHYL) IMIDAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, IN PARTICULAR A POTASSIUM SALT; REGISTERED: SE 12209 19940902; UK 0025/0324 19941215; UK 0025/0336 19941215

Similar Applicant Names

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

• Genus
• Genus Lifesciences

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

In the dynamic world of pharmaceuticals, understanding the competitive landscape is crucial for success. Genus Lifesciences, a specialty pharmaceutical company founded in 1999, has carved out a unique position in the market. This article delves into Genus Lifesciences' market position, strengths, and strategic insights, providing valuable information for industry professionals and investors alike.

Company Overview

Genus Lifesciences, headquartered in Allentown, Pennsylvania, is a manufacturer of branded and generic pharmaceutical products[1]. With over two decades of experience, the company has established itself as a significant player in the U.S. pharmaceutical market.

Key Facts

• Founded: 1999
• Headquarters: Allentown, PA
• Employees: Over 150 professionals
• Revenue: $32.7 million (as of 2025)[4]
• Funding: $2 million[4]

Market Position

Genus Lifesciences has positioned itself as a leader in a specific niche within the pharmaceutical industry. The company is renowned for its success in obtaining FDA approval for previously unapproved drugs[1].

Specialization in Unapproved Drugs

Genus Lifesciences addresses a critical regulatory concern by performing necessary clinical and non-clinical studies to ensure the safety and efficacy of unapproved drugs[1]. This unique focus has allowed the company to:

1. Aid in removing unapproved drugs from commerce
2. Establish itself as a national leader in 505(b)(2) New Drug Applications

Product Portfolio and Distribution

Genus Lifesciences manufactures and distributes several high-quality products, all approved by the FDA under various regulatory pathways[7]. These products reach a wide range of customers through diverse distribution channels.

Distribution Network

• Retail chains
• Hospitals
• Mail-order companies
• Other dispensing organizations

Products are distributed throughout the United States via various wholesalers and distributors[7].

Technological Strengths

Genus Lifesciences leverages several technological strengths to maintain its competitive edge in the pharmaceutical market.

Diversion and Abuse Resistant Technologies (DART)

DART allows dosage manufacturers to improve a product's resistance to:

• Abuse
• Illegal diversion
• Potential overdose[1]

Good Manufacturing Practices (GMPs)

Genus Lifesciences employs GMPs in all aspects of its operations, ensuring high-quality standards across:

• Production facilities
• Analytical laboratories
• Employee training
• Other critical elements[7]

Research and Development

Genus Lifesciences maintains a strong focus on research and development, which is crucial in the pharmaceutical industry.

Global Partnerships

The company engages in ongoing research efforts through global partnerships related to its technology platforms[1]. This approach allows Genus to:

1. Stay at the forefront of pharmaceutical innovation
2. Access diverse expertise and resources
3. Potentially expand its market reach

Competitive Advantages

Genus Lifesciences has several competitive advantages that set it apart in the pharmaceutical landscape.

Expertise in Regulatory Approval

The company's success in obtaining FDA approval for previously unapproved drugs gives it a unique edge in the market[1]. This expertise allows Genus to:

1. Address critical regulatory concerns
2. Tap into markets that other companies might overlook
3. Establish strong relationships with regulatory bodies

Quality Assurance

Genus Lifesciences' commitment to quality is evident in its adherence to Good Manufacturing Practices (GMPs)[7]. This focus on quality:

1. Enhances the company's reputation
2. Ensures product safety and efficacy
3. Potentially reduces the risk of regulatory issues

Market Challenges and Opportunities

Like any pharmaceutical company, Genus Lifesciences faces both challenges and opportunities in the current market landscape.

Challenges

1. Intense competition in the pharmaceutical industry
2. Stringent regulatory requirements
3. High costs associated with drug development and approval

Opportunities

1. Growing demand for safe and effective pharmaceutical products
2. Potential for expansion into new therapeutic areas
3. Possibilities for strategic partnerships and collaborations

Strategic Insights

Based on the available information, we can glean several strategic insights about Genus Lifesciences' approach to the pharmaceutical market.

Focus on Niche Markets

By specializing in obtaining FDA approval for previously unapproved drugs, Genus Lifesciences has carved out a unique niche in the pharmaceutical industry[1]. This strategy allows the company to:

1. Differentiate itself from competitors
2. Address an underserved market need
3. Potentially face less direct competition

Emphasis on Quality and Compliance

Genus Lifesciences' strong focus on Good Manufacturing Practices (GMPs) and regulatory compliance[7] suggests a strategy that prioritizes:

1. Product quality and safety
2. Building trust with regulators and customers
3. Long-term sustainability over short-term gains

Investment in Technology

The company's development of technologies like DART[1] indicates a strategic focus on:

1. Innovation in drug delivery and safety
2. Addressing critical issues in the pharmaceutical industry
3. Creating additional value for customers and patients

Competitive Analysis

To fully understand Genus Lifesciences' position in the market, it's crucial to conduct a thorough competitive analysis.

Identifying Competitors

While specific competitors are not mentioned in the provided information, we can infer that Genus Lifesciences likely competes with:

1. Other specialty pharmaceutical companies
2. Generic drug manufacturers
3. Larger pharmaceutical companies with diverse portfolios

SWOT Analysis

A brief SWOT analysis can provide further insights into Genus Lifesciences' competitive position:

Strengths

• Expertise in obtaining FDA approval for unapproved drugs
• Strong focus on quality and compliance
• Innovative technologies like DART

Weaknesses

• Relatively small size compared to major pharmaceutical companies
• Limited product portfolio

Opportunities

• Potential for expansion into new therapeutic areas
• Growing demand for safe and effective pharmaceutical products

Threats

• Intense competition in the pharmaceutical industry
• Stringent and evolving regulatory requirements

Future Outlook

Based on the available information, Genus Lifesciences appears well-positioned for future growth and success in the pharmaceutical industry.

Potential Growth Areas

1. Expansion of product portfolio
2. Further development of innovative technologies
3. Potential strategic partnerships or acquisitions

Challenges to Address

1. Maintaining competitive edge in a rapidly evolving industry
2. Navigating complex regulatory landscapes
3. Balancing innovation with cost management

Key Takeaways

1. Genus Lifesciences has established a unique niche in obtaining FDA approval for previously unapproved drugs.
2. The company's focus on quality, compliance, and innovative technologies provides significant competitive advantages.
3. Genus Lifesciences' strategic approach balances specialization with potential for growth and expansion.
4. The company faces challenges typical of the pharmaceutical industry but appears well-positioned to address them.
5. Future success will likely depend on continued innovation, strategic partnerships, and adaptability to market changes.

FAQs

1. What is Genus Lifesciences' primary focus in the pharmaceutical industry? Genus Lifesciences specializes in obtaining FDA approval for previously unapproved drugs, performing necessary studies to ensure their safety and efficacy.

2. How does Genus Lifesciences ensure product quality? The company adheres to Good Manufacturing Practices (GMPs) in all aspects of its operations, including production facilities, analytical laboratories, and employee training.

3. What is DART, and why is it significant? DART (Diversion and Abuse Resistant Technologies) is a technology developed by Genus Lifesciences that improves a product's resistance to abuse, illegal diversion, and potential overdose.

4. How does Genus Lifesciences distribute its products? The company distributes its products to retail chains, hospitals, mail-order companies, and other dispensing organizations throughout the United States via various wholesalers and distributors.

5. What are some potential growth areas for Genus Lifesciences? Potential growth areas include expanding its product portfolio, further developing innovative technologies, and exploring strategic partnerships or acquisitions.

"Genus Lifesciences is a national leader in the submission of 505(b)(2) New Drug Applications, for products previously sold as Unapproved Products."[1]

Sources cited:

1. https://genuslifesciences.com
2. https://rocketreach.co/genus-lifesciences-inc-profile_b45798bcfca5dae7
3. https://genuslifesciences.com/products-facilities/