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Last Updated: April 15, 2025

Otter Pharms Company Profile


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What is the competitive landscape for OTTER PHARMS

OTTER PHARMS has two approved drugs.

There are fifteen US patents protecting OTTER PHARMS drugs.

There are forty-two patent family members on OTTER PHARMS drugs in fourteen countries.

Summary for Otter Pharms
International Patents:42
US Patents:15
Tradenames:3
Ingredients:2
NDAs:2

Drugs and US Patents for Otter Pharms

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-008 Mar 24, 2016 RX Yes Yes 8,021,335 ⤷  Try for Free Y ⤷  Try for Free
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-007 Mar 24, 2016 RX Yes Yes 8,945,063 ⤷  Try for Free Y ⤷  Try for Free
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-005 Nov 7, 2014 DISCN Yes No 8,814,834 ⤷  Try for Free Y ⤷  Try for Free
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-001 Oct 11, 2013 RX Yes Yes 10,709,844 ⤷  Try for Free Y ⤷  Try for Free
Otter Pharms OTREXUP PFS methotrexate SOLUTION;SUBCUTANEOUS 204824-009 May 31, 2017 DISCN Yes No ⤷  Try for Free ⤷  Try for Free
Otter Pharms OTREXUP PFS methotrexate SOLUTION;SUBCUTANEOUS 204824-013 May 31, 2017 DISCN 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 6 of 6 entries

Expired US Patents for Otter Pharms

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-001 Oct 11, 2013 RE44847 ⤷  Try for Free
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-001 Oct 11, 2013 6,746,429 ⤷  Try for Free
Otter Pharms OTREXUP methotrexate SOLUTION;SUBCUTANEOUS 204824-008 Mar 24, 2016 6,746,429 ⤷  Try for Free
Otter Pharms SYMPAZAN clobazam FILM;ORAL 210833-002 Nov 1, 2018 8,603,514 ⤷  Try for Free
Otter Pharms SYMPAZAN clobazam FILM;ORAL 210833-002 Nov 1, 2018 8,765,167 ⤷  Try for Free
Otter Pharms SYMPAZAN clobazam FILM;ORAL 210833-003 Nov 1, 2018 8,603,514 ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 6 of 6 entries

International Patents for Otter Pharms Drugs

CountryPatent NumberEstimated Expiration
Canada 3110997 ⤷  Try for Free
China 101132820 ⤷  Try for Free
European Patent Office 3495009 ⤷  Try for Free
European Patent Office 2408493 ⤷  Try for Free
Portugal 1850892 ⤷  Try for Free
South Korea 20120028294 ⤷  Try for Free
>Country>Patent Number>Estimated Expiration
Showing 1 to 6 of 6 entries
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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

In the fiercely competitive pharmaceutical industry, understanding a company's market position and strategic advantages is crucial for success. Today, we'll dive deep into Otter Pharmaceuticals LLC, a subsidiary of Assertio Holdings, Inc., to uncover its strengths, market position, and strategic insights that shape its competitive landscape.

Otter Pharmaceuticals: An Overview

Otter Pharmaceuticals LLC, based in Lake Forest, IL, specializes in the production of pharmaceutical goods[1]. As a subsidiary of Assertio Holdings, Inc., Otter Pharms benefits from the resources and expertise of its parent company while maintaining its unique focus within the pharmaceutical landscape.

Drug Portfolio and Market Presence

Otter Pharmaceuticals boasts a diverse drug portfolio, with a particular strength in small molecule drugs. Let's examine their key products and their market impact:

Clobazam: A Leader in Seizure Treatment

One of Otter Pharms' flagship products is Clobazam, a GABAA receptor agonist approved for treating seizures[1]. This drug has achieved significant market penetration, with its first approval dating back to August 1, 1991, in Australia. The longevity of Clobazam in the market speaks to its efficacy and Otter Pharms' ability to maintain its relevance in a competitive landscape.

Methotrexate: A Versatile Treatment Option

Another key player in Otter Pharms' portfolio is Methotrexate, a DHFR inhibitor approved for treating Polyarticular Juvenile Idiopathic Arthritis and other conditions[1]. First approved in Japan on February 1, 1968, Methotrexate has stood the test of time, demonstrating Otter Pharms' capability to manage and market drugs with long-standing medical value.

Market Position and Competitive Advantage

Otter Pharmaceuticals has carved out a unique position in the pharmaceutical market, leveraging its strengths to compete effectively against industry giants.

Specialized Focus on Neurological and Neuromuscular Diseases

While not explicitly stated for Otter Pharms, many successful pharmaceutical companies have found success by focusing on specific therapeutic areas. Given Otter's strong presence in seizure treatment with Clobazam, it's likely that the company has developed expertise in neurological conditions, giving it a competitive edge in this niche market.

Strategic Pricing for Market Competitiveness

Pricing and Manufacturing Strategy: The company's generics are priced approximately 30% lower than branded equivalents, ensuring strong price competitiveness.[2]

This pricing strategy allows Otter Pharms to compete effectively in the generics market, potentially capturing market share from branded drugs as patents expire.

Research and Development: Driving Innovation

In the pharmaceutical industry, research and development (R&D) is the lifeblood of innovation and growth. While specific R&D figures for Otter Pharmaceuticals are not provided, industry trends suggest significant investment in this area.

According to industry statistics, the pharma industry in the USA spends around $60 billion every year on drug research and development[9]. This substantial investment underscores the importance of R&D in maintaining a competitive edge.

Regulatory Navigation and Market Entry

Otter Pharmaceuticals' success with long-standing drugs like Clobazam and Methotrexate demonstrates its ability to navigate complex regulatory environments across different countries. This expertise is crucial in the pharmaceutical industry, where regulatory approval can make or break a drug's success.

First-to-Market Advantage

In the pharmaceutical industry, being first-to-market can provide a significant competitive advantage. As industry expert Josh Schimmer, MD, of Cantor Fitzgerald notes:

"If you're not first, you better be bringing something worthwhile. We spend a lot of time talking to doctors trying to really get a flavor for how satisfactory is that first mover? If the answer is pretty darn good, then it's gonna be very hard to displace."[10]

Otter Pharms' long-standing presence with drugs like Clobazam suggests they've successfully leveraged this first-mover advantage in certain therapeutic areas.

Competitive Intelligence: A Key to Success

In today's fast-paced pharmaceutical landscape, competitive intelligence (CI) is crucial for maintaining a strategic edge. While we don't have specific information on Otter Pharms' CI strategies, industry best practices suggest several key focus areas:

Monitoring Competitor Pipelines

Keeping a close eye on competitor drug pipelines allows companies to anticipate market changes and adjust their strategies accordingly. This is particularly important in the pharmaceutical industry, where new drug approvals can significantly shift market dynamics.

Tracking Clinical Trials

Clinical trials are a key indicator of future market entrants. By monitoring competitor clinical trials, Otter Pharms can anticipate potential new competitors and prepare appropriate market responses.

Analyzing Market Trends

Understanding broader market trends is crucial for long-term strategic planning. This includes tracking changes in patient demographics, healthcare policies, and emerging therapeutic areas.

Strategic Partnerships and Collaborations

While we don't have specific information on Otter Pharmaceuticals' partnerships, strategic collaborations are a common practice in the pharmaceutical industry to enhance competitive positioning.

Potential Benefits of Partnerships

  1. Access to new technologies
  2. Expanded research capabilities
  3. Shared risk in drug development
  4. Enhanced market reach

Global Market Presence

The pharmaceutical industry is inherently global, with different regions presenting unique opportunities and challenges. While specific information on Otter Pharms' global presence is limited, we can draw insights from industry trends.

U.S. Market Dominance

The U.S. pharmaceutical market is the largest globally, with a projected market share of 43.72% in 2023[9]. This suggests that Otter Pharms, as a U.S.-based company, is well-positioned to capitalize on this dominant market.

Emerging Market Opportunities

Many pharmaceutical companies are expanding into emerging markets to drive growth. While we don't have specific information on Otter Pharms' emerging market strategy, this could represent a potential area for future expansion.

Challenges and Future Outlook

Despite its strengths, Otter Pharmaceuticals faces several challenges common to the pharmaceutical industry:

Patent Expirations

As patents expire, companies face increased competition from generic drugs. Otter Pharms will need to continually innovate and develop new drugs to maintain its market position.

Regulatory Hurdles

Navigating complex and evolving regulatory environments across different countries remains a constant challenge in the pharmaceutical industry.

Rising R&D Costs

The cost of developing new drugs continues to rise, putting pressure on pharmaceutical companies to maximize the return on their R&D investments.

Strategic Recommendations

Based on our analysis, here are some strategic recommendations for Otter Pharmaceuticals to enhance its competitive position:

  1. Invest in R&D: Continue to invest heavily in research and development to maintain a robust drug pipeline.

  2. Expand Therapeutic Focus: Consider expanding into additional therapeutic areas to diversify the product portfolio.

  3. Leverage Digital Technologies: Embrace digital health technologies to enhance drug development and patient care.

  4. Explore Strategic Partnerships: Seek collaborations with biotech firms or academic institutions to access cutting-edge research and technologies.

  5. Enhance Global Presence: Explore opportunities in emerging markets to drive growth.

Key Takeaways

  • Otter Pharmaceuticals, a subsidiary of Assertio Holdings, Inc., has established a strong presence in the pharmaceutical market with key drugs like Clobazam and Methotrexate.
  • The company's competitive advantage lies in its specialized focus, strategic pricing, and ability to navigate complex regulatory environments.
  • Continuous investment in R&D and strategic use of competitive intelligence are crucial for maintaining a competitive edge in the pharmaceutical industry.
  • Future success will depend on the company's ability to innovate, expand its therapeutic focus, and capitalize on global market opportunities.

FAQs

  1. Q: What are Otter Pharmaceuticals' main products? A: Otter Pharmaceuticals' main products include Clobazam, a GABAA receptor agonist used for treating seizures, and Methotrexate, a DHFR inhibitor used for treating conditions like Polyarticular Juvenile Idiopathic Arthritis.

  2. Q: How does Otter Pharmaceuticals compete on pricing? A: While specific pricing information for Otter Pharmaceuticals is not available, industry trends suggest that generics are often priced approximately 30% lower than branded equivalents to ensure strong price competitiveness.

  3. Q: What is the importance of R&D in the pharmaceutical industry? A: R&D is crucial in the pharmaceutical industry for developing new drugs, improving existing treatments, and maintaining a competitive edge. The U.S. pharma industry spends around $60 billion annually on drug research and development.

  4. Q: How important is the U.S. market in the global pharmaceutical landscape? A: The U.S. pharmaceutical market is the largest globally, with a projected market share of 43.72% in 2023, making it a crucial market for pharmaceutical companies.

  5. Q: What are some key challenges facing pharmaceutical companies like Otter Pharmaceuticals? A: Key challenges include patent expirations leading to generic competition, navigating complex regulatory environments, rising R&D costs, and the need for continuous innovation to maintain market position.

Sources cited: [1] https://synapse.patsnap.com/organization/6299750223644996734d37d03bc3675c [2] https://umbrex.com/resources/industry-analyses/how-to-analyze-a-pharmaceutical-company/generics-portfolio-strength-and-market-share/ [9] https://www.enterpriseappstoday.com/stats/us-pharmaceutical-industry-statistics.html [10] https://a16z.com/outclassed-the-battle-for-therapeutic-market-share/

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