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Last Updated: March 16, 2025

Swedish Orphan Company Profile


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Summary for Swedish Orphan
International Patents:21
US Patents:1
Tradenames:1
Ingredients:1
NDAs:2

Drugs and US Patents for Swedish Orphan

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-002 Jan 18, 2002 AB RX Yes No ⤷  Try for Free ⤷  Try for Free
Swedish Orphan ORFADIN nitisinone SUSPENSION;ORAL 206356-001 Apr 22, 2016 RX Yes Yes 9,301,932 ⤷  Try for Free Y ⤷  Try for Free
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-001 Jan 18, 2002 AB RX Yes No ⤷  Try for Free ⤷  Try for Free
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-004 Jun 13, 2016 AB RX Yes Yes ⤷  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 4 of 4 entries

Expired US Patents for Swedish Orphan

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-001 Jan 18, 2002 5,006,158 ⤷  Try for Free
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-003 Jan 18, 2002 5,550,165 ⤷  Try for Free
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-002 Jan 18, 2002 5,550,165 ⤷  Try for Free
Swedish Orphan ORFADIN nitisinone CAPSULE;ORAL 021232-001 Jan 18, 2002 5,550,165 ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 4 of 4 entries

Supplementary Protection Certificates for Swedish Orphan Drugs

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
0591275 05C0024 France ⤷  Try for Free PRODUCT NAME: NITISINONE; REGISTRATION NO/DATE: EU/1/04/303/001 20050221
0591275 C300198 Netherlands ⤷  Try for Free PRODUCT NAME: NITISINONE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAAR DBAAR ZOUT; REGISTRATION NO/DATE: EU/1/04/303/001-003 20050201
0591275 SPC/GB05/030 United Kingdom ⤷  Try for Free PRODUCT NAME: NITISINONE (2-(2-NITRO-4-TRIFLUOROMETHYLBENZOYL)-1,3-CYCLOHEXANEDIONE) OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/303/001 20050221; UK EU/1/04/303/002 20050221; UK EU/1/04/303/003 20050221
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 3 of 3 entries
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

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

Swedish Orphan Biovitrum AB (Sobi) has established itself as a prominent player in the pharmaceutical industry, specializing in rare diseases and orphan drugs. This analysis delves into Sobi's market position, strengths, and strategic insights, providing a comprehensive overview of the company's competitive landscape.

Company Overview

Swedish Orphan Biovitrum AB, commonly known as Sobi, is an international biopharmaceutical company headquartered in Stockholm, Sweden. Founded in 2001, Sobi has grown to become a leader in rare disease treatments, focusing on areas such as haematology, immunology, and specialty care[1].

Market Position

Sobi has carved out a strong position in the orphan drug market, which is experiencing significant growth. The global orphan drug market was valued at USD 232.12 billion in 2023 and is expected to grow at a CAGR of 9.7% from 2024 to 2030[3]. This growth trajectory presents substantial opportunities for companies like Sobi that specialize in rare disease treatments.

Geographic Presence

Sobi has established a diverse geographical presence, with operations spanning Europe, the Middle East, North America, Russia, and Asia[4]. This global footprint allows the company to tap into various markets and leverage regional opportunities.

Product Portfolio

Sobi's product portfolio focuses on several key therapeutic areas:

  1. Haemophilia
  2. Immunology
  3. Specialty Care
  4. Inflammation
  5. Genetic and Metabolic Diseases

The company's flagship products include Elocta and Alprolix for haemophilia treatment, Doptelet for immune thrombocytopenia (ITP) and chronic liver disease (CLD), Kineret for various inflammatory disorders, and Gamifant for primary hemophagocytic lymphohistiocytosis (pHLH)[1].

Financial Performance

Sobi has demonstrated strong financial performance in recent years. In the fourth quarter of 2024, the company reported:

  • Total revenue of SEK 7,436 million, a 9% year-over-year increase
  • Adjusted EBITA of SEK 2,557 million
  • Profit for the period of SEK 1,391 million, a 36% year-over-year increase[2]

This financial growth underscores Sobi's strong market position and effective business strategies.

Strengths and Competitive Advantages

Expertise in Rare Diseases

Sobi's focus on rare diseases and orphan drugs has allowed the company to develop deep expertise in these niche areas. This specialization gives Sobi a competitive edge in a market that requires highly specialized knowledge and capabilities.

Strong R&D Pipeline

The company maintains a robust research and development pipeline, with several products in pre-market stages. These include treatments for paroxysmal nocturnal hemoglobinuria (PNH), haemophilia, secondary hemophagocytic lymphohistiocytosis (sHLH), acute graft failure (aGF), amyotrophic lateral sclerosis (ALS), and chronic refractory gout[1].

Strategic Partnerships

Sobi has established valuable partnerships with other pharmaceutical companies, enhancing its product portfolio and market reach. For example, the company has agreements with Amgen for products like Kepivance, Stemgen, and Kineret, and with Biogen for hemophilia treatments[1].

Market Leadership in Orphan Drugs

Sobi's specialization in orphan drugs has positioned it as a market leader in this growing segment. The company's focus on addressing unmet patient needs in rare diseases has contributed to its strong market position[8].

Strategic Insights

Focus on Innovation

Sobi's strategy heavily emphasizes innovation, particularly in developing novel treatments for rare diseases. This focus on innovation is crucial in maintaining a competitive edge in the rapidly evolving pharmaceutical landscape.

Expansion through Acquisitions

The company has pursued strategic acquisitions to expand its product portfolio and market presence. For instance, Sobi acquired Dova Pharmaceuticals, strengthening its position in the hematology space[2].

Geographical Expansion

Sobi continues to expand its geographical footprint, particularly in North America. This strategy allows the company to tap into new markets and diversify its revenue streams.

Emphasis on Rare Disease Treatments

By focusing on rare diseases, Sobi addresses a critical need in the healthcare sector while benefiting from regulatory incentives and market exclusivity often associated with orphan drugs.

Challenges and Opportunities

Challenges

  1. High Development Costs: The development of orphan drugs often involves high costs due to the complexity of rare diseases and smaller patient populations.

  2. Regulatory Hurdles: Navigating the regulatory landscape for rare disease treatments can be challenging and time-consuming.

  3. Competition: Despite the niche nature of orphan drugs, competition in this space is increasing as more companies recognize the potential of this market segment.

Opportunities

  1. Growing Orphan Drug Market: The expanding orphan drug market presents significant growth opportunities for Sobi.

  2. Unmet Medical Needs: Many rare diseases still lack effective treatments, providing opportunities for Sobi to develop novel therapies.

  3. Technological Advancements: Advances in biotechnology and genomics offer new possibilities for developing targeted treatments for rare diseases.

Future Outlook

Sobi's future looks promising, given its strong market position, robust product pipeline, and focus on the growing orphan drug market. The company's strategic focus on innovation and geographical expansion is likely to drive continued growth.

"Swedish Orphan Biovitrum AB (Sobi) is an international biopharmaceutical company dedicated to treatments in the areas of haematology, immunology and specialty care, based in Stockholm, Sweden."[1]

As the demand for rare disease treatments continues to grow, Sobi is well-positioned to capitalize on this trend. However, the company will need to navigate challenges such as increasing competition and regulatory complexities to maintain its market leadership.

Key Takeaways

  1. Sobi has established a strong position in the orphan drug market, specializing in rare disease treatments.
  2. The company's financial performance shows consistent growth, with a 9% increase in total revenue in Q4 2024.
  3. Sobi's strengths include its expertise in rare diseases, strong R&D pipeline, and strategic partnerships.
  4. The company's focus on innovation and geographical expansion are key drivers of its competitive strategy.
  5. While facing challenges such as high development costs and regulatory hurdles, Sobi is well-positioned to capitalize on the growing orphan drug market.

FAQs

  1. What is Swedish Orphan Biovitrum AB's main focus? Swedish Orphan Biovitrum AB (Sobi) primarily focuses on developing and marketing treatments for rare diseases, particularly in the areas of haematology, immunology, and specialty care.

  2. How has Sobi's financial performance been in recent years? Sobi has shown strong financial performance, with a 9% year-over-year increase in total revenue in Q4 2024, reaching SEK 7,436 million.

  3. What are some of Sobi's key products? Some of Sobi's key products include Elocta and Alprolix for haemophilia treatment, Doptelet for ITP and CLD, Kineret for inflammatory disorders, and Gamifant for pHLH.

  4. How is Sobi positioned in the global orphan drug market? Sobi is well-positioned in the global orphan drug market, which is expected to grow at a CAGR of 9.7% from 2024 to 2030. The company's specialization in rare diseases gives it a competitive advantage in this growing market.

  5. What are the main challenges and opportunities for Sobi in the coming years? Main challenges include high development costs and regulatory hurdles, while opportunities lie in the growing orphan drug market, addressing unmet medical needs, and leveraging technological advancements in biotechnology and genomics.

Sources cited: [1] https://en.wikipedia.org/wiki/Swedish_Orphan_Biovitrum [2] https://www.marketscreener.com/quote/stock/SWEDISH-ORPHAN-BIOVITRUM--6499130/news/Swedish-Orphan-Biovitrum-AB-s-4Q-profits-up-by-36-49014278/ [3] https://www.maximizemarketresearch.com/market-report/orphan-drugs-market/342/ [4] https://www.globaldata.com/company-profile/swedish-orphan-biovitrum-ab/ [8] https://www.globaldata.com/company-profile/swedish-orphan-biovitrum-ab/swot-analysis/

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