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Last Updated: March 22, 2025

Santarus Inc Company Profile


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Summary for Santarus Inc
International Patents:23
US Patents:1
Tradenames:1
Ingredients:1
NDAs:1

Drugs and US Patents for Santarus Inc

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-002 Jun 3, 2005 AB3 RX Yes Yes 7,780,987 ⤷  Try for Free Y Y ⤷  Try for Free
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-001 Jun 3, 2005 AB3 RX Yes No ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 2 of 2 entries

Expired US Patents for Santarus Inc

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-001 Jun 3, 2005 6,635,280 ⤷  Try for Free
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-002 Jun 3, 2005 6,340,475 ⤷  Try for Free
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-002 Jun 3, 2005 8,323,692 ⤷  Try for Free
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-001 Jun 3, 2005 6,340,475 ⤷  Try for Free
Santarus Inc GLUMETZA metformin hydrochloride TABLET, EXTENDED RELEASE;ORAL 021748-001 Jun 3, 2005 6,488,962 ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 5 of 5 entries
Paragraph IV (Patent) Challenges for SANTARUS INC drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Extended-release Tablets 500 mg and 1000 mg ➤ Subscribe 2009-07-27

Supplementary Protection Certificates for Santarus Inc Drugs

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
1506211 122014000070 Germany ⤷  Try for Free PRODUCT NAME: KOMBINATION VON DAPAGLIFLOZIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON UND METFORMIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, WIE DURCH DAS GRUNDPATENT GESCHUETZT; REGISTRATION NO/DATE: EU/1/13/900 20140116
1506211 132014902277722 Italy ⤷  Try for Free PRODUCT NAME: UNA COMBINAZIONE DI DAPAGLIFLOZIN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E METFORMINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE COME PROTETTI DAL BREVETTO DI BASE EP1506211(XIGDUO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/900, 20140116
2498758 301040 Netherlands ⤷  Try for Free PRODUCT NAME: METFORMINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; SAXAGLIPTINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; DAPAGLIFLOZINE OF EEN FARMACEUTISCH AANVAARDBAAR SOLVAAT DAARVAN; REGISTRATION NO/DATE: EU/1/19/1401 20191113
1730131 C01730131/02 Switzerland ⤷  Try for Free PRODUCT NAME: EMPAGLIFLOZIN UND METFORMINHYDROCHLORID; REGISTRATION NO/DATE: SWISSMEDIC 65570 12.11.2015
1261586 C300524 Netherlands ⤷  Try for Free PRODUCT NAME: COMBINATIE VAN SAXAGLIPTINE EN METFORMINE, DESGEWENST IN DE VORM VAN FARMACEUTISCH AANVAARDBARE AFGELEIDEN DAARVAN; NAT. REGISTRATION NO/DATE: EU/1/11/731/001-012 20111124; FIRST REGISTRATION:
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 5 of 5 entries
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Pharmaceutical Competitive Landscape Analysis: Santarus Inc – Market Position, Strengths & Strategic Insights

In the dynamic world of pharmaceuticals, understanding the competitive landscape is crucial for success. This comprehensive analysis delves into Santarus Inc., a specialty biopharmaceutical company that has made significant strides in the industry. We'll explore its market position, strengths, and strategic insights to provide a clear picture of where Santarus stands in the pharmaceutical arena.

Santarus Inc: Company Overview

Santarus Inc., founded in 1996, is a specialty biopharmaceutical company focused on acquiring, developing, and commercializing proprietary products for the prevention and treatment of gastrointestinal diseases and disorders[1]. The company's primary business strategy revolves around 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.

Key Facts About Santarus

  • Founded: 1996
  • Headquarters: San Diego, California
  • Total Funding Raised: $42.71M
  • Acquisition Status: Acquired by Salix Pharmaceuticals in 2013
  • Number of Patents: 23
  • Primary Focus: Gastrointestinal diseases and disorders

Market Position and Product Portfolio

Santarus has established a strong presence in the gastrointestinal (GI) market, with a portfolio of products targeting various GI-related conditions. The company's market position is bolstered by its focus on developing innovative formulations and delivery systems for existing compounds.

Key Products in Santarus' Portfolio

  1. ZEGERID: An immediate-release proton pump inhibitor (PPI) for treating upper gastrointestinal diseases and disorders[2].
  2. GLUMETZA: A metformin HCl extended-release tablet for treating type 2 diabetes[2].
  3. UCERIS: A treatment for mild to moderate active ulcerative colitis[3].

Pipeline Products

Santarus has been actively developing new products to expand its portfolio:

  1. Budesonide MMX: In Phase III clinical trials for induction of remission of mild or moderate active ulcerative colitis[2].
  2. Rifamycin SV MMX: In Phase III clinical testing for the treatment of travelers' diarrhea[2].
  3. RUCONEST: A recombinant human C1 esterase inhibitor for treating acute angioedema attacks in patients with hereditary angioedema[3].

Competitive Strengths of Santarus

Santarus has several competitive advantages that have contributed to its success in the pharmaceutical industry:

1. Focus on Specialty Markets

By concentrating on specialty pharmaceutical products, particularly in the GI space, Santarus has carved out a niche for itself. This focused approach allows the company to develop deep expertise and strong relationships with healthcare providers in its target markets.

2. Innovative Product Development Strategy

Santarus' strategy of developing new formulations or expanded indications for existing compounds reduces the risks associated with drug development while still providing opportunities for innovation.

3. Strong Patent Portfolio

With 23 patents filed, Santarus has built a robust intellectual property portfolio. The company's patents cover various areas, including antacids, dosage forms, and drug delivery devices[1].

4. Experienced Management Team

Santarus boasts a leadership team with extensive experience in the pharmaceutical industry, providing the company with valuable insights and strategic direction.

"Our employees have worked very hard to build Santarus into a premier specialty biopharmaceutical company. I would like to thank all of our employees for their contributions to making Santarus the successful company it is today." - Gerald T. Proehl, President and Chief Executive Officer, Santarus[3]

Strategic Insights and Market Trends

To fully understand Santarus' position in the pharmaceutical landscape, it's essential to consider broader industry trends and the company's strategic moves.

Consolidation in the Pharmaceutical Industry

The pharmaceutical industry has seen significant consolidation in recent years, with larger companies acquiring smaller, specialized firms to expand their product portfolios and market reach. Santarus itself was acquired by Salix Pharmaceuticals in 2013 for $2.6 billion[3].

This acquisition trend highlights the value of companies like Santarus, which have developed expertise in specific therapeutic areas and built strong relationships with healthcare providers.

Focus on Gastrointestinal Diseases

The global gastrointestinal drugs market is expected to grow significantly in the coming years, driven by factors such as the increasing prevalence of GI disorders and the aging population. Santarus' focus on this area positions it well to capitalize on this growing market.

Emphasis on Primary Care

Santarus' strategy of expanding into primary care settings represents a significant opportunity for growth. By leveraging its specialty sales force to promote products in primary care, the company can potentially capture a larger market share[3].

Competitive Landscape Analysis

To fully appreciate Santarus' position, it's crucial to understand its competitors and how the company stacks up against them.

Key Competitors

Some of Santarus' main competitors include:

  1. Humanetics
  2. Intarcia Therapeutics
  3. Zosano Pharma
  4. Annovis Bio
  5. Aerogen[1]

Comparative Analysis

While specific financial data for these private companies may not be readily available, we can compare them based on factors such as product portfolio, therapeutic focus, and development pipeline.

Santarus stands out due to its:

  1. Diverse product portfolio spanning multiple GI conditions
  2. Strong presence in both specialty and primary care markets
  3. Robust pipeline of late-stage development products

SWOT Analysis of Santarus

A SWOT analysis provides a structured way to evaluate Santarus' competitive position:

Strengths

  • Strong focus on GI diseases
  • Innovative product development strategy
  • Robust patent portfolio
  • Experienced management team

Weaknesses

  • Reliance on a relatively small number of products
  • Vulnerability to generic competition (as seen with ZEGERID)[2]

Opportunities

  • Growing global market for GI drugs
  • Potential for expansion into primary care
  • Pipeline products in late-stage development

Threats

  • Intense competition in the pharmaceutical industry
  • Regulatory challenges
  • Potential for patent expirations

Strategic Moves and Future Outlook

Santarus has made several strategic moves to strengthen its market position and prepare for future growth:

1. Expansion into Primary Care

By promoting products like GLUMETZA in primary care settings, Santarus is expanding its reach beyond specialty markets[2].

2. Focus on Late-Stage Development Products

With multiple products in Phase III clinical trials, Santarus is positioning itself for future growth through new product launches[2].

3. Strategic Partnerships

Santarus has engaged in strategic partnerships to expand its reach. For example, it licensed rights to GlaxoSmithKline for ZEGERID immediate-release omeprazole products in over 100 countries[7].

Impact of Acquisition by Salix Pharmaceuticals

The acquisition of Santarus by Salix Pharmaceuticals in 2013 marked a significant milestone for the company. This strategic move has several implications:

1. Enhanced Market Position

The combined entity solidified its position as the largest U.S. gastroenterology-focused specialty pharmaceutical company[3].

2. Expanded Product Portfolio

The merger combined two complementary product portfolios, creating a stronger, more diverse offering in the GI space[3].

3. Increased Scale and Resources

As part of a larger organization, Santarus gained access to greater resources for research, development, and commercialization efforts.

"We believe the timing is right for this strategic combination with Salix, a highly respected company that is uniquely positioned to expand the commercialization of Santarus' marketed products and to continue to advance the development of our pipeline products." - Gerald T. Proehl, President and Chief Executive Officer, Santarus[3]

Lessons from Santarus' Success

Santarus' journey offers valuable insights for other pharmaceutical companies:

1. Focus on Niche Markets

By concentrating on specific therapeutic areas, companies can develop deep expertise and strong relationships with healthcare providers.

2. Innovate Within Established Frameworks

Santarus' strategy of developing new formulations or expanded indications for existing compounds demonstrates how innovation can occur within established regulatory and scientific frameworks.

3. Balance Specialty and Primary Care

Santarus' expansion into primary care while maintaining its specialty focus shows the potential benefits of a balanced approach to market penetration.

4. Prepare for Industry Consolidation

The acquisition of Santarus by Salix Pharmaceuticals highlights the importance of building a strong, attractive business that can provide value in the context of industry consolidation.

Key Takeaways

  1. Santarus has established a strong position in the gastrointestinal pharmaceutical market through a focused strategy and innovative product development approach.

  2. The company's strengths include its specialty market focus, robust patent portfolio, and experienced management team.

  3. Santarus' acquisition by Salix Pharmaceuticals in 2013 enhanced its market position and provided access to greater resources.

  4. The company's strategy of expanding into primary care while maintaining its specialty focus offers a model for balanced market penetration.

  5. Santarus' success demonstrates the value of focusing on niche markets and innovating within established frameworks in the pharmaceutical industry.

FAQs

  1. Q: What was Santarus' primary focus in the pharmaceutical industry? A: Santarus primarily focused on acquiring, developing, and commercializing proprietary products for the prevention and treatment of gastrointestinal diseases and disorders.

  2. Q: How many patents did Santarus file? A: Santarus filed 23 patents, covering areas such as antacids, dosage forms, and drug delivery devices.

  3. Q: What was a key strategic move made by Santarus to expand its reach? A: Santarus licensed rights to GlaxoSmithKline for ZEGERID immediate-release omeprazole products in over 100 countries, expanding its international presence.

  4. Q: When was Santarus acquired, and by which company? A: Santarus was acquired by Salix Pharmaceuticals in 2013 for $2.6 billion.

  5. Q: What was one of Santarus' innovative strategies in product development? A: Santarus focused on developing new formulations, enhanced delivery systems, or expanded indications for existing compounds with proven safety and efficacy, reducing development risks while still innovating.

Sources cited: [1] https://www.cbinsights.com/company/santarus [2] https://www.fiercebiotech.com/biotech/santarus-inc-snts-competitor-releases-generic-company-restructures-and-reduces-workforce-by [3] https://www.fiercepharma.com/m-a/salix-pharmaceuticals-to-acquire-santarus [7] https://www.biospace.com/santarus-inc-licenses-rights-to-glaxosmithkline-for-zegerid-immediate-release-omeprazole-products-in-over-100-countries

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