Santarus Company Profile

What is the competitive landscape for SANTARUS

SANTARUS has three approved drugs.

There is one US patent protecting SANTARUS drugs.

There are twenty-three patent family members on SANTARUS drugs in fourteen countries and sixty-seven supplementary protection certificates in fifteen countries.

Summary for Santarus

International Patents:	23
US Patents:	1
Tradenames:	3
Ingredients:	2
NDAs:	3

Drugs and US Patents for Santarus

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-002	Jun 3, 2005	AB3	RX	Yes	Yes	7,780,987		Y	Y
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-001	Jun 3, 2005	AB3	RX	Yes	No
Santarus	MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET;ORAL	022456-002	Dec 4, 2009		DISCN	No	No
Santarus	MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET;ORAL	022456-001	Dec 4, 2009		DISCN	No	No
Santarus	ZEGERID	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET, CHEWABLE;ORAL	021850-002	Mar 24, 2006		DISCN	No	No
Santarus	ZEGERID	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET, CHEWABLE;ORAL	021850-001	Mar 24, 2006		DISCN	No	No

Expired US Patents for Santarus

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-001	Jun 3, 2005	6,635,280
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-002	Jun 3, 2005	6,723,340
Santarus Inc	GLUMETZA	metformin hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021748-002	Jun 3, 2005	6,635,280
Santarus	MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET;ORAL	022456-002	Dec 4, 2009	7,399,772
Santarus	ZEGERID	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET, CHEWABLE;ORAL	021850-002	Mar 24, 2006	7,399,772
Santarus	ZEGERID	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET, CHEWABLE;ORAL	021850-001	Mar 24, 2006	6,489,346
Santarus	ZEGERID	magnesium hydroxide; omeprazole; sodium bicarbonate	TABLET, CHEWABLE;ORAL	021850-002	Mar 24, 2006	6,489,346

Paragraph IV (Patent) Challenges for SANTARUS drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Capsules	20 mg/1100 mg and 40 mg/1100 mg		2007-04-30
	Powder for Oral Suspension	20mg/1680mg per packet		2007-11-13
	Powder for Oral Suspension	40 mg/1680 mg per packet		2007-08-24
	Extended-release Tablets	500 mg and 1000 mg		2009-07-27

International Patents for Santarus Drugs

Country	Patent Number	Estimated Expiration
Australia	2003211145
Canada	2476496
Cyprus	1112517
Denmark	1476138
Japan	2005526043
Japan	5069395
Norway	20043913

Supplementary Protection Certificates for Santarus Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1499331	122014000007	Germany		PRODUCT NAME: NATRIUMSULFAT, MAGNESIUMSULFAT UND KALIUMSULFAT; NAT. REGISTRATION NO/DATE: 86203.00.00 20130808; FIRST REGISTRATION: BELGIEN BE434323 20130220
2498758	132020000000034	Italy		PRODUCT NAME: METFORMINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE; SAXAGLIPTIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE; DAPAGLIFLOZIN O UN SUO SOLVATO FARMACEUTICAMENTE ACCETTABILE.(QTRILMET); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1401, 20191113
1499331	13C0055	France		PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: BE - 434323 20130220
1506211	179 5017-2014	Slovakia		PRODUCT NAME: KOMBINACIA DAPAGLIFLOZINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI A METFORMINU ALEBO JEHO FARMACEUTICKY PRIJATELNYCH SOLI; REGISTRATION NO/DATE: EU/1/13/900/001 - EU/1/13/900/012 20140116
1730131	C01730131/02	Switzerland		PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
1412357	C300357	Netherlands		PRODUCT NAME: SITAGLIPTINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVA ARDBAAR ZOUT, IN HET BIJZONDER HET MONOFOSFAAT, EN METFORMINE DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716
1412357	DO 77; 5006-2008	Slovakia		PRODUCT NAME: SITAGLIPTIN A METFORMIN; REGISTRATION NO/DATE: EU/1/08/455/001-014 20080716

Similar Applicant Names

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

• Santarus
• Santarus Inc
• Santen

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

In the dynamic world of pharmaceuticals, understanding the competitive landscape is crucial for success. This article delves into a comprehensive analysis of Santarus, a specialty pharmaceutical company that has made significant strides in the industry. We'll explore Santarus's market position, strengths, and strategic insights that have shaped its journey in the pharmaceutical sector.

Santarus: A Brief Overview

Santarus, founded in 1996, has established itself as a key player in the specialty pharmaceutical market. The company's focus on acquiring, developing, and commercializing proprietary products for gastrointestinal diseases and disorders has been its hallmark strategy[1].

Market Position and Product Portfolio

Santarus has carved out a niche for itself in the pharmaceutical industry, particularly in the gastrointestinal (GI) market. The company's product portfolio includes several notable medications:

1. GLUMETZA® (metformin hydrochloride extended release tablets)
2. CYCLOSET® (bromocriptine mesylate) tablets
3. FENOGLIDE® (fenofibrate) tablets
4. UCERIS™ (budesonide) extended release tablets
5. ZEGERID® (omeprazole/sodium bicarbonate)[3]

These products target various conditions, including type 2 diabetes, high cholesterol, ulcerative colitis, and upper gastrointestinal disorders.

Strengths and Competitive Advantages

1. Focused Product Development Strategy

Santarus's strength lies in its targeted approach to product development. The company's primary business strategy involves developing and marketing proprietary products with new formulations, enhanced delivery systems, or expanded indications based on currently marketed products or compounds with proven safety and efficacy[1].

2. Strong Commercial Presence

The company has built a robust commercial infrastructure, particularly in the diabetes and gastrointestinal markets. This allows Santarus to effectively promote its products and capture market share[2].

3. Strategic Partnerships

Santarus has demonstrated a knack for forming strategic alliances that enhance its market position. For instance, the company's partnership with Schering-Plough Healthcare Products for the over-the-counter (OTC) version of ZEGERID opened up new revenue streams in the $1.6 billion OTC heartburn market[8].

4. Innovative Pipeline

Santarus maintains a healthy pipeline of products in various stages of development. This includes RUCONEST® (recombinant human C1 esterase inhibitor) for hereditary angioedema and rifamycin SV MMX® for travelers' diarrhea[7].

Strategic Insights

Diversification Strategy

Santarus has successfully diversified its product portfolio beyond its initial focus on gastrointestinal diseases. The company's expansion into diabetes treatment with GLUMETZA and CYCLOSET demonstrates its ability to adapt to market opportunities[3].

Focus on Specialty Markets

By concentrating on specialty pharmaceutical products, Santarus has positioned itself in markets with less competition from major pharmaceutical companies. This strategy allows for potentially higher profit margins and less price pressure[1].

Emphasis on Acquisitions and In-Licensing

Santarus's growth strategy includes acquiring or in-licensing products that complement its existing portfolio. This approach allows the company to expand its offerings without the full cost and risk of developing new drugs from scratch[1].

Market Challenges and Opportunities

Patent Expirations

Like many pharmaceutical companies, Santarus faces challenges related to patent expirations. The company must continually innovate or acquire new products to offset potential revenue losses from generic competition[3].

Regulatory Environment

The pharmaceutical industry is heavily regulated, and changes in regulations can significantly impact Santarus's operations. Staying abreast of regulatory changes and maintaining compliance is crucial for the company's success[3].

Expanding Market Reach

While Santarus has a strong presence in certain therapeutic areas, there's potential for expansion into new markets or geographic regions. This represents both a challenge and an opportunity for future growth[2].

Competitive Landscape

Santarus operates in a highly competitive environment, with rivals including both large pharmaceutical companies and other specialty pharma firms. Some of its competitors include:

1. Salix Pharmaceuticals
2. Intarcia Therapeutics
3. Phytomedics
4. Osteologix
5. Tempo Pharmaceuticals
6. ROXRO Pharma[1][4]

Each of these companies presents unique competitive challenges in Santarus's key markets.

Financial Performance and Valuation

Santarus's financial performance has been a key factor in its market position. The company's ability to generate revenue growth and manage expenses effectively has attracted investor interest.

In November 2013, Salix Pharmaceuticals announced its intention to acquire Santarus for approximately $2.6 billion. The $32.00 per share price represented a 36% premium over Santarus's closing price, indicating the perceived value of Santarus's market position and product portfolio[7].

This acquisition valuation provides insight into Santarus's strong market position and the value of its product portfolio and pipeline.

Future Outlook and Strategic Direction

Prior to its acquisition by Salix Pharmaceuticals, Santarus was poised for continued growth and expansion. The company's strategic direction included:

1. Leveraging its commercial infrastructure to promote existing products
2. Advancing its product pipeline through clinical development
3. Seeking additional product acquisition or in-licensing opportunities
4. Expanding into new therapeutic areas or geographic markets[2][3]

Impact of the Salix Acquisition

The acquisition by Salix Pharmaceuticals in 2013 marked a significant milestone in Santarus's journey. This strategic move was expected to:

1. Solidify Salix's position as the largest U.S. gastroenterology-focused specialty pharmaceutical company
2. Combine complementary product portfolios
3. Expand the pipeline of both companies
4. Diversify revenue streams
5. Access a broader range of healthcare providers, including those in primary care[4][7]

Lessons for the Pharmaceutical Industry

Santarus's journey offers several valuable lessons for other players in the pharmaceutical industry:

1. Focus on niche markets: Specializing in specific therapeutic areas can lead to strong market positions.
2. Balance between marketed products and pipeline: Maintaining a mix of revenue-generating products and promising pipeline candidates is crucial for sustainable growth.
3. Strategic partnerships: Collaborations can open up new markets and revenue streams.
4. Adaptability: The ability to pivot and expand into new therapeutic areas can drive growth.

Key Takeaways

1. Santarus established a strong position in the specialty pharmaceutical market, particularly in gastrointestinal and diabetes treatments.
2. The company's focused product development strategy and strategic partnerships were key strengths.
3. Santarus successfully diversified its product portfolio beyond its initial focus, demonstrating adaptability.
4. The acquisition by Salix Pharmaceuticals for $2.6 billion underscored Santarus's strong market position and valuable product portfolio.
5. Santarus's journey offers valuable lessons for other pharmaceutical companies, including the importance of focusing on niche markets and maintaining a balanced product portfolio.

FAQs

1. What were Santarus's main therapeutic areas of focus? Santarus primarily focused on gastrointestinal diseases and disorders, as well as diabetes treatment.

2. How did Santarus's acquisition by Salix Pharmaceuticals impact the market? The acquisition solidified Salix's position as the largest U.S. gastroenterology-focused specialty pharmaceutical company and combined complementary product portfolios.

3. What was Santarus's key strategy for product development? Santarus focused on developing and marketing proprietary products with new formulations, enhanced delivery systems, or expanded indications based on currently marketed products or compounds with proven safety and efficacy.

4. How did Santarus manage to compete with larger pharmaceutical companies? By focusing on specialty markets and niche products, Santarus was able to compete effectively with larger pharmaceutical companies in specific therapeutic areas.

5. What were some of Santarus's most notable products? Some of Santarus's key products included GLUMETZA, CYCLOSET, UCERIS, and ZEGERID, targeting conditions such as diabetes, ulcerative colitis, and gastrointestinal disorders.

Sources cited:

1. https://www.cbinsights.com/company/santarus
2. https://www.annualreports.com/HostedData/AnnualReports/PDF/snts2010.pdf
3. https://www.fiercepharma.com/regulatory/santarus-receives-fda-approval-of-uceris-budesonide-for-induction-of-remission-patients
4. https://www.drugdiscoverynews.com/salix-pharmaceuticals-to-acquire-santarus-7919
5. https://www.businesswire.com/news/home/20131107006615/en/Salix-Pharmaceuticals-to-Acquire-Santarus
6. https://www.biospace.com/santarus-inc-announces-submission-of-new-drug-application-by-schering-plough-healthcare-products-for-zegerid-branded-otc-product