Salix Pharms Company Profile

What is the competitive landscape for SALIX PHARMS

SALIX PHARMS has nine approved drugs.

There are twenty-eight US patents protecting SALIX PHARMS drugs.

There are two hundred and fifty-two patent family members on SALIX PHARMS drugs in forty-two countries and eighty-six supplementary protection certificates in eleven countries.

Summary for Salix Pharms

International Patents:	252
US Patents:	28
Tradenames:	9
Ingredients:	8
NDAs:	9

Drugs and US Patents for Salix Pharms

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Salix Pharms	METOZOLV ODT	metoclopramide hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	022246-002	Sep 4, 2009		DISCN	Yes	No
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-002	Sep 27, 2010	AP	RX	Yes	Yes	9,492,445		Y
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-003	Sep 27, 2010	AP	RX	Yes	Yes	9,180,125		Y
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-002	Mar 24, 2010		RX	Yes	Yes	10,456,384

Expired US Patents for Salix Pharms

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Salix Pharms	PEPCID	famotidine	FOR SUSPENSION;ORAL	019527-001	Feb 2, 1987	4,283,408*PED
Salix Pharms	RELISTOR	methylnaltrexone bromide	SOLUTION;SUBCUTANEOUS	021964-002	Sep 27, 2010	9,669,096
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-001	May 25, 2004	7,612,199
Salix Pharms	XIFAXAN	rifaximin	TABLET;ORAL	021361-001	May 25, 2004	8,158,781

Paragraph IV (Patent) Challenges for SALIX PHARMS drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	For Oral Solution	100 g, 7.5 g, 2.691 g, 1.015 g, 5.9 g and 4.7 g per pouch		2007-11-27
	Injection	8 mg/0.4 mL		2015-09-08
	Orally Disintegrating Tablets	5 mg and 10 mg		2010-08-24
	Tablets	550 mg		2015-12-18
	Injection	12 mg/0.6 mL		2015-07-22
	Tablets	150 mg		2016-09-06
	Tablets	1.102 g and 0.398 g		2008-04-09
	Tablets	200 mg		2019-01-28

International Patents for Salix Pharms Drugs

Country	Patent Number	Estimated Expiration
Mexico	2011003400
Mexico	2010009197
Moldova, Republic of	4081
Tunisia	SN06069

Supplementary Protection Certificates for Salix Pharms Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2673237	1990016-6	Sweden		PRODUCT NAME: SODIUM ZIRCONIUM CYCLOSILICATE; REG. NO/DATE: EU/1/17/1173 20180326
1758590	2017C/063	Belgium		PRODUCT NAME: SEL DE SODIUM D'ACIDE DESOXYCHOLIQUE; AUTHORISATION NUMBER AND DATE: SE/H/1547/01/DC 20170612
0290047	97C0108	Belgium		PRODUCT NAME: MANGAFODIPIR TRISODIUM (ANHYDROUS) CORRESP. MANGAFODIPIR; REGISTRATION NO/DATE: EU/1/97/040/001 19970522
0957929	SPC/GB06/021	United Kingdom		PRODUCT NAME: PEGAPTANIB, PREFERABLY IN THE FORM OF ITS SODIUM SALT; REGISTERED: UK EU/1/05/325/001 20060201

Similar Applicant Names

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

• Salix
• Salix Pharms

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

Salix Pharmaceuticals, a subsidiary of Bausch Health, has established itself as a significant player in the pharmaceutical industry, particularly in the gastrointestinal (GI) therapeutics market. This comprehensive analysis delves into Salix's market position, strengths, and strategic insights, providing valuable information for industry professionals and investors alike.

Company Overview

Salix Pharmaceuticals, founded in 1989, has grown to become the largest gastroenterology-focused pharmaceutical company in the world[1]. Headquartered in Bridgewater, New Jersey, Salix specializes in developing and marketing prescription drugs and medical devices for various gastrointestinal disorders[1].

Market Position

Salix's strong market position is evident from its impressive financial performance and product portfolio. In 2014, the company reported total sales of $1.1 billion, showcasing its significant presence in the pharmaceutical industry[1].

Key Products

Salix's product lineup includes several successful treatments for GI disorders:

1. XIFAXAN® 550: A leading product with 18% year-over-year prescription demand growth[2].
2. APRISO®: Showed 10% year-over-year prescription demand growth[2].
3. RELISTOR®: Experienced a remarkable 67% year-over-year prescription demand growth[2].
4. UCERIS®: Demonstrated 47% year-over-year prescription demand growth[2].

These products have contributed significantly to Salix's market dominance in the GI therapeutics sector.

Financial Performance

Salix's financial performance underscores its strong market position:

• Total net product revenue was projected to be between $1.25 billion and $1.35 billion in 2015[2].
• Gross margins were estimated at approximately 80%[2].
• EBITDA was projected to be between $360 million and $440 million[2].

"These important milestones should enhance our competitive position and expand our market opportunities," said Carolyn Logan, President and Chief Executive Officer of Salix Pharmaceuticals[7].

Strengths and Competitive Advantages

1. Focused Expertise

Salix's specialization in gastrointestinal disorders gives it a competitive edge in this niche market. This focused approach allows for deeper understanding and more targeted research and development efforts.

2. Strong Product Portfolio

The company's diverse range of GI treatments caters to various patient needs, solidifying its market position. Products like XIFAXAN® 550 and APRISO® have shown consistent growth, indicating their effectiveness and market acceptance[2].

3. Innovative Research and Development

Salix's commitment to innovation is evident from its strategic collaborations and research initiatives. The company has expanded its microbiome research and discovery through strategic partnerships, positioning itself at the forefront of GI treatment advancements[9].

4. Effective Acquisition Strategy

Salix has successfully grown through strategic acquisitions, such as InKine Pharmaceutical Company, Oceana Therapeutics, and Santarus[1]. These acquisitions have expanded its product portfolio and market reach.

Strategic Insights

1. Focus on Late-Stage and Marketed Products

Salix's strategy involves in-licensing or acquiring late-stage or marketed proprietary therapeutic products[8]. This approach minimizes development risks and accelerates time-to-market for new treatments.

2. Patent Protection

The company prioritizes patent protection for its key products. For instance, Apriso is expected to be patent-protected until 2022, ensuring continued revenue streams[8].

3. Diversification within GI Therapeutics

While maintaining its focus on GI disorders, Salix has diversified its product offerings to address various conditions within this therapeutic area. This strategy helps mitigate risks associated with over-reliance on a single product.

4. Strategic Partnerships

Salix actively pursues strategic partnerships to enhance its research capabilities and market reach. For example, its agreement with Photocure for Lumacan demonstrates its commitment to exploring new diagnostic technologies in GI care[1].

Competitive Landscape

In the GI therapeutics market, Salix faces competition from several pharmaceutical companies:

1. AbbVie
2. Boehringer Ingelheim
3. Sucampo Pharmaceuticals (now part of Mallinckrodt)
4. Ironwood Pharmaceuticals[5]

Despite this competition, Salix's focused approach and strong product portfolio have helped maintain its leading position in the GI therapeutics market.

Future Outlook

Salix's future looks promising, with several factors contributing to its potential growth:

1. Expanding product pipeline
2. Continued focus on GI disorders
3. Strategic partnerships and collaborations
4. Potential for international market expansion

However, the company also faces challenges, including:

1. Intense competition in the pharmaceutical industry
2. Regulatory hurdles
3. Patent expirations of key products

Key Takeaways

1. Salix Pharmaceuticals is the world's largest gastroenterology-focused pharmaceutical company.
2. The company's strong product portfolio, including XIFAXAN® 550 and APRISO®, drives its market leadership.
3. Salix's focused expertise in GI disorders provides a competitive advantage.
4. Strategic acquisitions and partnerships have been crucial to Salix's growth and innovation.
5. The company faces competition but maintains a strong position through its specialized approach and diverse product offerings.

FAQs

1. Q: What is Salix Pharmaceuticals' primary focus? A: Salix Pharmaceuticals specializes in developing and marketing prescription drugs and medical devices for gastrointestinal disorders.

2. Q: Who are Salix Pharmaceuticals' main competitors? A: Salix's main competitors include AbbVie, Boehringer Ingelheim, Sucampo Pharmaceuticals, and Ironwood Pharmaceuticals.

3. Q: What are some of Salix Pharmaceuticals' key products? A: Some of Salix's key products include XIFAXAN® 550, APRISO®, RELISTOR®, and UCERIS®.

4. Q: How does Salix Pharmaceuticals approach research and development? A: Salix focuses on in-licensing or acquiring late-stage or marketed proprietary therapeutic products and also engages in strategic partnerships for research and development.

5. Q: What are the main challenges facing Salix Pharmaceuticals? A: The main challenges include intense competition in the pharmaceutical industry, regulatory hurdles, and the risk of patent expirations affecting its revenue base.

Sources cited: [1] https://en.wikipedia.org/wiki/Salix_Pharmaceuticals [2] https://www.fiercepharma.com/financials/salix-pharmaceuticals-provides-updates-on-wholesaler-inventory-reductions-and-xifaxan%C2%AE [5] https://pitchgrade.com/companies/ironwood-pharmaceuticals-inc [7] https://www.fiercepharma.com/financials/salix-pharmaceuticals-reports-3q2014-results [8] https://www.dcatvci.org/features/valeant-s-acquisition-of-salix-the-implications-in-specialty-pharma/ [9] https://ir.bauschhealth.com/~/media/Files/V/Valeant-IR/press-release/20180803-salix-expands-microbiome-research-and-discovery-through-strategic-collaboration.pdf