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Last Updated: March 18, 2025

Shorla Oncology Company Profile


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Summary for Shorla Oncology
International Patents:6
US Patents:1
Tradenames:1
Ingredients:1
NDAs:1

Drugs and US Patents for Shorla Oncology

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Shorla Oncology IMKELDI imatinib mesylate SOLUTION;ORAL 219097-001 Nov 22, 2024 RX Yes Yes 11,957,681 ⤷  Try for Free Y ⤷  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 1 of 1 entries

International Patents for Shorla Oncology Drugs

CountryPatent NumberEstimated Expiration
Australia 2018306149 ⤷  Try for Free
China 111278466 ⤷  Try for Free
European Patent Office 3658190 ⤷  Try for Free
Russian Federation 2020108342 ⤷  Try for Free
Singapore 11202001720R ⤷  Try for Free
World Intellectual Property Organization (WIPO) 2019021229 ⤷  Try for Free
>Country>Patent Number>Estimated Expiration
Showing 1 to 6 of 6 entries

Supplementary Protection Certificates for Shorla Oncology Drugs

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
0564409 02C0012 France ⤷  Try for Free PRODUCT NAME: IMATINIB MESILATE; NAT. REGISTRATION NO/DATE: EU/1/01/198/001 20011107; FIRST REGISTRATION: LI - IKS 55 807 20010621
0564409 2002/005 Ireland ⤷  Try for Free PRODUCT NAME: IMATINIB OR ONE OF ITS PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALTS, ESPECIALLY THE MONOMETHANESULFONATE SALT; NAT REGISTRATION NO/DATE: EU/1/01/198/001-006 20011107; FIRST REGISTRATION NO/DATE: CH 55807 55807 01 55807 02 20010621; PAEDIATRIC INVESTIGATION PLAN: P/0028/2012
0564409 C00564409/01 Switzerland ⤷  Try for Free PRODUCT NAME: IMATINIB; REGISTRATION NO/DATE: IKS 55807 20010621
0564409 C300086 Netherlands ⤷  Try for Free PRODUCT NAME: IMATINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZUURADDITIEZOUT, IN HET BIJZONDER HET MESILAAT; NATL. REGISTRATION NO/DATE: EU/1/01/198/001 - 006 20011107; FIRST REGISTRATION: CH IKS 55807 20010621
0564409 SPC/GB02/016 United Kingdom ⤷  Try for Free PRODUCT NAME: IMATINIB (INN I.E. NON INTELLECTUAL PROPRIETARY NAME) OR ONE OF ITS PHARMACEUTICALLY ACCEPTABLE ACID ADDITION SALTS, ESPECIALLY THE MONOMETHANESULFONATE SALT; REGISTERED: CH IKS-NR: 55807 20010621; UK SG(2001) D/292083 20011108
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 5 of 5 entries
Similar Applicant Names
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Pharmaceutical Competitive Landscape Analysis: Shorla Oncology – Market Position, Strengths & Strategic Insights

In the ever-evolving landscape of pharmaceutical innovation, Shorla Oncology has emerged as a notable player, carving out a unique niche in the oncology drug market. This US-Ireland specialty pharmaceutical company has garnered attention for its focused approach to addressing unmet needs in cancer treatment, particularly in orphan and pediatric cancers. Let's delve into Shorla's market position, strengths, and strategic insights that are shaping its trajectory in the competitive pharmaceutical industry.

Shorla Oncology's Innovative Approach

Shorla Oncology's business model revolves around "formulation re-innovation," a strategy that sets it apart in the pharmaceutical landscape. This approach involves developing and commercializing reformulated versions of existing cancer treatments, with a particular focus on improving convenience and addressing drug shortages[1].

"We effectively expedited the development of a sterile drug product to treat T-ALL," says Sharon Cunningham, CEO of Shorla Oncology. "In doing so we removed both the financial and emotional burdens placed on patients who are forced to purchase costly alternative treatments or cease treatment if no alternatives exist."[2]

This patient-centric approach not only addresses critical market gaps but also aligns with the growing demand for more accessible and effective cancer treatments.

Market Position and Product Portfolio

FDA-Approved Products

Shorla Oncology has made significant strides in establishing its market presence. The company boasts four FDA-approved drugs in its portfolio, a remarkable achievement for a relatively young company[10]. This rapid progress in gaining regulatory approvals demonstrates Shorla's efficiency in navigating the complex pharmaceutical development and approval processes.

Pipeline and Development Strategy

Shorla's pipeline is robust and strategically aligned with its mission. The company plans to have four products on the market and three or more in development by the end of 2024[1]. This ambitious goal reflects Shorla's commitment to continuous innovation and market expansion.

Key products in Shorla's pipeline include:

  1. SH-105 (TEPYLUTE): Approved for breast and ovarian cancer
  2. SH-110: In development for glioma
  3. SH-201: In late-stage development for various leukemias and gastrointestinal tumors[1]

Strategic Strengths and Competitive Advantages

Focus on Unmet Needs

Shorla Oncology's strategic focus on orphan and pediatric cancers addresses a critical gap in the pharmaceutical market. By targeting areas where existing treatments are limited, in shortage, or inadequate for specific patient populations, Shorla has positioned itself as a solution provider in underserved market segments[6].

Efficient Development Model

The company's approach to drug development, which involves reimagining existing cancer drugs, allows for a more streamlined and cost-effective R&D process. This model reduces the risks and costs associated with traditional drug discovery while accelerating the time to market[2].

Flexible Commercialization Strategy

Shorla has developed a flexible go-to-market strategy that combines in-house expertise with external commercial partnerships. This approach allows the company to adapt its commercialization efforts on a case-by-case basis, optimizing resource allocation and market penetration[1].

Market Dynamics and Growth Potential

Oncology Drug Market Overview

The global oncology drugs market is experiencing significant growth, valued at USD 179.96 Billion in 2021 and projected to reach USD 368.22 Billion by 2027, growing at a CAGR of 12.74%[4]. This robust market growth provides a favorable environment for Shorla's expansion plans.

Targeted Therapy Trend

Within the oncology drug market, targeted therapy is gaining prominence. This category, which includes gene therapy and immunotherapy, is expected to account for a significant revenue share in the coming years. Shorla's focus on innovative formulations aligns well with this market trend[4].

Strategic Partnerships and Funding

Recent Funding Success

In October 2023, Shorla Oncology secured $35 million in Series B funding, led by Kurma Partners' Growth Opportunities Fund[5][6]. This substantial investment provides Shorla with the financial resources to accelerate its product development and market expansion efforts.

Collaborative Approach

Shorla's strategy includes both in-house development and strategic acquisitions. The company has demonstrated its ability to quickly integrate and commercialize acquired products, as evidenced by its acquisition and launch of an FDA-approved oncology drug from a UK-based company in just two months[2].

Challenges and Future Outlook

Competitive Landscape

While Shorla has carved out a unique position, the oncology drug market remains highly competitive. Major players like GlaxoSmithKline, Eli Lilly & Company, and Roche continue to dominate the market[4]. Shorla will need to maintain its innovative edge to compete effectively.

Regulatory Environment

Navigating the complex regulatory landscape remains a challenge for pharmaceutical companies. However, Shorla's track record of FDA approvals suggests a strong capability in this area.

Future Growth Strategies

Shorla's future growth strategies may include:

  1. Expanding its product portfolio through continued in-house development and strategic acquisitions
  2. Leveraging AI and emerging technologies to enhance R&D efficiency
  3. Exploring new geographic markets beyond the US and Ireland

Key Takeaways

  1. Shorla Oncology has established a unique position in the oncology drug market through its focus on formulation re-innovation and addressing unmet needs in orphan and pediatric cancers.

  2. The company's efficient development model and flexible commercialization strategy provide competitive advantages in a rapidly growing market.

  3. Recent funding success and a robust pipeline position Shorla for continued growth and market expansion.

  4. Shorla's ability to navigate regulatory challenges and quickly bring products to market demonstrates operational excellence.

  5. The company's future success will depend on maintaining its innovative edge, effectively competing with larger pharmaceutical companies, and capitalizing on emerging market trends and technologies.

FAQs

  1. What is Shorla Oncology's primary focus in drug development? Shorla Oncology focuses on developing reformulated versions of existing cancer treatments, particularly for orphan and pediatric cancers, addressing drug shortages and improving treatment convenience.

  2. How many FDA-approved drugs does Shorla Oncology currently have? As of early 2025, Shorla Oncology has four FDA-approved drugs in its portfolio.

  3. What was the value of Shorla Oncology's recent Series B funding round? Shorla Oncology secured $35 million in Series B funding in October 2023.

  4. What is the projected growth rate of the global oncology drugs market? The global oncology drugs market is projected to grow at a CAGR of 12.74% from 2022 to 2027.

  5. How does Shorla Oncology's development strategy differ from traditional pharmaceutical companies? Shorla Oncology employs a "formulation re-innovation" strategy, which involves reimagining existing cancer drugs to improve efficacy, safety, and accessibility, rather than focusing on discovering entirely new compounds.

Sources cited: [1] https://shorlaoncology.com/pipeline/ [2] https://substack.com/app-link/post?publication_id=1367396&post_id=151822337&action=share&triggerShare=true&isFreemail=true&r=2l93z&token=eyJ1c2VyX2lkIjo0MzUwODE1LCJwb3N0X2lkIjoxNTE4MjIzMzcsImlhdCI6MTczMTk2MzcxMCwiZXhwIjoxNzM0NTU1NzEwLCJpc3MiOiJwdWItMTM2NzM5NiIsInN1YiI6InBvc3QtcmVhY3Rpb24ifQ.al9NgjRpEounOPG-QluqtMVqyB2zXJ1sK3g3ToUVCLE [4] https://www.researchandmarkets.com/reports/5569604/oncology-drugs-market-insights-competitive [5] https://www.pharmaceutical-technology.com/news/shorla-funds-oncology-drug-candidates/ [6] https://www.businesswire.com/news/home/20231004152524/en/Shorla-Oncology-Secures-35M-Series-B-Funding-Round-to-Advance-its-Oncology-Product-Portfolio [10] https://www.irishtimes.com/business/2025/01/10/shorla-oncology-co-founders-we-felt-compelled-to-do-something-meaningful/

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