Waylis Therap Company Profile

What is the competitive landscape for WAYLIS THERAP

WAYLIS THERAP has eleven approved drugs.

There is one US patent protecting WAYLIS THERAP drugs.

There are twenty-four patent family members on WAYLIS THERAP drugs in fourteen countries and five supplementary protection certificates in four countries.

Summary for Waylis Therap

International Patents:	24
US Patents:	1
Tradenames:	11
Ingredients:	11
NDAs:	11

Drugs and US Patents for Waylis Therap

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Waylis Therap	COREG	carvedilol	TABLET;ORAL	020297-004	May 29, 1997	AB	RX	Yes	No
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-002	Oct 20, 2006		DISCN	Yes	No	8,101,209*PED				Y
Waylis Therap	JALYN	dutasteride; tamsulosin hydrochloride	CAPSULE;ORAL	022460-001	Jun 14, 2010	AB	RX	Yes	Yes
Waylis Therap	THIOGUANINE	thioguanine	TABLET;ORAL	012429-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes

Expired US Patents for Waylis Therap

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-003	Oct 20, 2006	6,022,562*PED
Waylis Therap	COREG CR	carvedilol phosphate	CAPSULE, EXTENDED RELEASE;ORAL	022012-004	Oct 20, 2006	7,268,156*PED
Waylis Therap	LUNESTA	eszopiclone	TABLET;ORAL	021476-003	Dec 15, 2004	6,864,257*PED
Waylis Therap	VALIUM	diazepam	TABLET;ORAL	013263-002	Approved Prior to Jan 1, 1982	4,316,897

Paragraph IV (Patent) Challenges for WAYLIS THERAP drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Capsules	0.5 mg		2007-10-29
	Tablets	1 mg, 2 mg and 3 mg		2008-12-15
	Extended-release Capsules	10 mg and 20 mg		2008-03-18
	Extended-release Capsules	80 mg		2007-11-19
	Capsule	0.5 mg/0.4 mg		2010-10-26
	Extended-release Capsules	40 mg		2007-12-21

International Patents for Waylis Therap Drugs

Country	Patent Number	Estimated Expiration
Brazil	0213175
Canada	2563689
China	1976682
South Africa	200402460

Supplementary Protection Certificates for Waylis Therap Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0268956	1999C0030	Belgium		PRODUCT NAME: RABEPRAZOLE SODIUM; NAT. REGISTRATION NO/DATE: 5532 IE 1 F 3 19990201; FIRST REGISTRATION: GB 10555/0010 19980508
0719278	23/2003	Austria		PRODUCT NAME: DUTASTERIDE, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SOLVATES; NAT. REGISTRATION NO/DATE: 1-24844, 1-24845 20030217; FIRST REGISTRATION: SE 17871, 17872 20020719
0719278	SPC/GB03/018	United Kingdom		PRODUCT NAME: DUTASTERIDE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SOLVATE.; REGISTERED: SE 17871 20020719; SE 17872 20020719; UK PL 19494/0005 20030117; UK PL 19494/0006 20030117
0268956	SPC/GB98/040	United Kingdom		PRODUCT NAME: RABEPRAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE SODIUM SALT; REGISTERED: UK 10555/0010 19980508; UK 10555/0008 19980508

Similar Applicant Names

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

• Waylis Therap

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

In the ever-evolving pharmaceutical industry, understanding a company's market position and competitive landscape is crucial for investors, analysts, and industry professionals. This comprehensive analysis delves into Waylis Therapeutics, a privately-owned pharmaceutical corporation based in Plymouth, Michigan, USA. We'll explore their market position, strengths, strategic insights, and how they stack up against competitors in this dynamic sector.

Company Overview

Waylis Therapeutics LLC is carving out its niche in the pharmaceutical industry with a focus on several key therapeutic areas. As of January 23, 2025, the company has been making strides in drug development and market presence[1].

Therapeutic Focus Areas

Waylis Therapeutics has demonstrated a diverse portfolio, with particular emphasis on:

1. Neoplasms (4 drugs)
2. Immune System Diseases (3 drugs)
3. Nervous System Diseases (3 drugs)
4. Hemic and Lymphatic Diseases (3 drugs)
5. Endocrinology and Metabolic Diseases (2 drugs)
6. Infectious Diseases (1 drug)[1]

This spread across multiple disease domains indicates a strategic approach to diversifying risk and capitalizing on various market opportunities.

Drug Pipeline and Development

Key Products

Waylis Therapeutics' pipeline includes several notable drugs:

1. Dutasteride/Tamsulosin Hydrochloride

   • Target: 5α-reductase x α1A-AR
   • Indication: Prostatic Hyperplasia
   • Status: Approved (First approval in US on June 14, 2010)[1]

2. Carvedilol Phosphate

   • Target: α-adrenergic receptor x β1-adrenergic receptor
   • Indications: Heart Failure (active), Essential Hypertension (inactive)
   • Status: Approved (First approval in US on October 20, 2006)[1]

3. Eszopiclone

   • Target: GABAA receptor
   • Indication: Sleep Initiation and Maintenance Disorders
   • Status: Approved (First approval in US on December 15, 2004)[1]

Technology Platforms

While specific technology platforms are not detailed in the available data, Waylis Therapeutics' focus on small molecule drugs (10 in development) suggests a strong capability in this area of drug development[1].

Market Position and Competitive Landscape

To understand Waylis Therapeutics' market position, it's essential to consider the broader pharmaceutical landscape and how the company compares to its peers.

Industry Trends

The pharmaceutical industry is experiencing several key trends:

1. Precision Medicine: There's a growing focus on developing targeted therapies, particularly in oncology.

2. Immunotherapies: Continued advancements in harnessing the immune system to fight diseases.

3. Gene Therapies: Emerging as a promising area for treating previously untreatable conditions.

4. Digital Health Integration: Increasing use of technology in drug development and patient care.

Competitive Analysis

While direct competitors for Waylis Therapeutics are not specified in the available data, we can infer potential competition based on their therapeutic areas:

1. Oncology: Companies like Roche, Merck, and Bristol Myers Squibb are major players in this space.

2. Immunology: AbbVie, Johnson & Johnson, and Novartis have strong positions in immune-related diseases.

3. Neurology: Biogen, Eli Lilly, and Pfizer are significant competitors in nervous system diseases.

"In the competitive landscape of oncology, AstraZeneca's Capivasertib has already gained approval and is quickly establishing itself as a preferred agent in the second-line setting, with sales reaching $142 million in the first half of 2024."[2]

This insight from the competitive landscape of Relay Therapeutics, another player in the oncology space, provides context for the level of competition Waylis Therapeutics might face in its neoplasm-focused drug development efforts.

Strengths and Strategic Insights

Strengths

1. Diverse Portfolio: Waylis Therapeutics' focus on multiple therapeutic areas spreads risk and opens various market opportunities[1].

2. Established Products: With approved drugs like Dutasteride/Tamsulosin Hydrochloride and Carvedilol Phosphate, the company has proven its ability to bring products to market[1].

3. Small Molecule Expertise: The company's pipeline suggests strong capabilities in small molecule drug development[1].

Strategic Insights

1. Focus on High-Need Areas: The company's emphasis on neoplasms and immune system diseases aligns with areas of high unmet medical need and market potential.

2. Balancing Portfolio: By maintaining a mix of approved products and pipeline candidates, Waylis Therapeutics balances current revenue streams with future growth potential.

3. Potential for Partnerships: Given its diverse portfolio, Waylis Therapeutics could be well-positioned for strategic partnerships or collaborations to enhance its market presence.

Recent Developments and Future Outlook

Recent FDA Filings

Waylis Therapeutics has been active in FDA filings, with several submissions for prescription medications in early 2025:

• February 9, 2025: Two filings for prescription medications
• January 29, 2025: One filing for a prescription medication
• January 26, 2025: One filing for a prescription medication
• January 10, 2025: Five filings for prescription medications[5]

This flurry of regulatory activity suggests an aggressive push to expand their product offerings and market presence.

Patient Access Programs

Waylis Therapeutics has demonstrated a commitment to patient access through its Waylis Patient Access & Affordability program. This initiative aims to reduce out-of-pocket costs for patients prescribed their medications, including TABLOID®[9].

Market Challenges and Opportunities

Challenges

1. Intense Competition: The pharmaceutical industry is highly competitive, with established players and emerging biotech companies vying for market share.

2. Regulatory Hurdles: Navigating the complex regulatory landscape remains a significant challenge for all pharmaceutical companies.

3. Pricing Pressures: Increasing scrutiny on drug pricing could impact profit margins and market access strategies.

Opportunities

1. Emerging Markets: Expanding into developing countries could provide new growth avenues.

2. Digital Health Integration: Leveraging technology in drug development and patient care could improve efficiency and outcomes.

3. Personalized Medicine: Advances in genomics and data analytics present opportunities for more targeted therapies.

Comparative Analysis

While direct comparisons to Waylis Therapeutics are limited in the available data, insights from other pharmaceutical companies can provide context:

Jazz Pharmaceuticals

• Focused on portfolio diversification through new drug approvals and acquisitions
• Successfully launched drugs in oncology and neurology, areas where Waylis also has a presence
• Acquired GW Pharmaceuticals for $7.2 billion, contributing $865 million to 2023 revenue[10]

This strategy of diversification and strategic acquisitions could be a model for Waylis Therapeutics to consider as it seeks to expand its market presence.

Key Takeaways

1. Waylis Therapeutics has a diverse portfolio spanning multiple therapeutic areas, with a strong focus on neoplasms and immune system diseases.

2. The company has demonstrated success in bringing products to market, with several approved drugs in its portfolio.

3. Recent FDA filings indicate an aggressive push for expansion and new product approvals.

4. Waylis Therapeutics' focus on patient access through affordability programs could be a key differentiator in the competitive pharmaceutical landscape.

5. The company's expertise in small molecule drug development positions it well in a market that continues to value these therapies alongside emerging modalities.

6. While facing intense competition, Waylis Therapeutics has opportunities for growth through strategic partnerships, market expansion, and leveraging emerging technologies in drug development.

7. The pharmaceutical industry's trends towards precision medicine and digital health integration present both challenges and opportunities for companies like Waylis Therapeutics.

FAQs

1. Q: What are Waylis Therapeutics' main therapeutic focus areas? A: Waylis Therapeutics focuses primarily on neoplasms, immune system diseases, nervous system diseases, hemic and lymphatic diseases, endocrinology and metabolic diseases, and infectious diseases.

2. Q: How does Waylis Therapeutics support patient access to their medications? A: Waylis Therapeutics has implemented the Waylis Patient Access & Affordability program to reduce out-of-pocket costs for patients prescribed their medications.

3. Q: What types of drugs does Waylis Therapeutics specialize in developing? A: Based on available data, Waylis Therapeutics appears to specialize in small molecule drug development, with 10 such drugs in their pipeline.

4. Q: How active is Waylis Therapeutics in seeking regulatory approvals? A: Waylis Therapeutics has been very active in FDA filings, with multiple submissions for prescription medications in early 2025, indicating an aggressive push for product expansion.

5. Q: What potential growth strategies could Waylis Therapeutics pursue? A: Potential growth strategies for Waylis Therapeutics could include expanding into emerging markets, leveraging digital health technologies, pursuing strategic partnerships or acquisitions, and focusing on personalized medicine approaches.

Sources cited: [1] https://synapse.patsnap.com/organization/16841bf2ec9fc8c0eb4090714840157f [2] https://www.investing.com/news/swot-analysis/relay-therapeutics-swot-analysis-stock-poised-for-growth-amid-fierce-competition-93CH-3819663 [5] https://fda.report/Company/Waylis-Therapeutics-L-L-C [9] https://tabloidrx.com/faqs/ [10] https://www.morningstar.com/stocks/best-biotech-stocks-buy