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Last Updated: December 25, 2024

SIKLOS Drug Patent Profile


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Which patents cover Siklos, and when can generic versions of Siklos launch?

Siklos is a drug marketed by Theravia and is included in one NDA.

The generic ingredient in SIKLOS is hydroxyurea. There are ten drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the hydroxyurea profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Siklos

A generic version of SIKLOS was approved as hydroxyurea by BARR on October 16th, 1998.

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Summary for SIKLOS
Drug patent expirations by year for SIKLOS
Drug Prices for SIKLOS

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Recent Clinical Trials for SIKLOS

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
PHINC DEVELOPMENTPhase 1
ADDMEDICA SASAPhase 1
Oncodesign SAPhase 1

See all SIKLOS clinical trials

Pharmacology for SIKLOS
Drug ClassAntimetabolite

US Patents and Regulatory Information for SIKLOS

SIKLOS is protected by zero US patents and one FDA Regulatory Exclusivity.

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Theravia SIKLOS hydroxyurea TABLET;ORAL 208843-002 Dec 21, 2017 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Theravia SIKLOS hydroxyurea TABLET;ORAL 208843-001 Dec 21, 2017 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

SIKLOS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for SIKLOS

Introduction to SIKLOS

SIKLOS, also known as hydroxyurea, is a prescription medicine used to reduce the frequency of painful crises and the need for blood transfusions in patients with sickle cell anemia. Here, we will delve into the market dynamics and financial trajectory of SIKLOS, a crucial drug in the treatment of sickle cell disease.

Market Size and Growth

The global sickle cell disease treatment market, within which SIKLOS operates, is experiencing significant growth. As of 2022, the global market size was valued at USD 2.25 billion and is projected to grow to USD 9.84 billion by 2030, with a Compound Annual Growth Rate (CAGR) of 20.1% during the forecast period of 2023-2030[1][4].

Treatment Modality and Segment Growth

The pharmacotherapy segment, which includes drugs like SIKLOS, is expected to lead the market growth. This segment's high growth rate is attributed to the launch of new branded pharmacotherapy drugs and increasing government initiatives supporting early launches of these drugs. The pharmacotherapy segment is anticipated to grow at the fastest CAGR during the forecast period due to these factors[1].

Distribution and Marketing

SIKLOS is marketed and distributed in the United States by Medunik USA, through an exclusive agreement with ADDMEDICA, a French pharmaceutical company specializing in hematology. This partnership has been instrumental in ensuring the availability of SIKLOS for patients in the U.S., particularly for children with sickle cell anemia[5].

Impact of COVID-19

The COVID-19 pandemic had a mixed impact on the sickle cell disease treatment market. While the pharmacotherapy segment, including drugs like SIKLOS, was not significantly affected due to the continued commercialization of branded pharmaceutical treatments, other segments such as blood transfusions and bone marrow transplants saw a decline in growth in 2020. This decline was due to the reallocation of healthcare resources towards COVID-19 treatment and a reduction in the number of patients seeking sickle cell disease treatment during the pandemic[1].

Government Support and Regulatory Environment

Government support plays a crucial role in the growth of the pharmacotherapy segment. In countries like the U.S. and India, governments provide funding and designations such as orphan drugs, fast track, and priority review to support research activities for sickle cell disease treatment. These initiatives accelerate the introduction of new pharmacotherapy drugs, including SIKLOS, and provide significant momentum to the market[1].

End-User Segmentation

The market is segmented into hospitals, specialty clinics, and others based on end-users. Hospitals dominated the global sickle cell disease treatment market share in 2022 due to the increasing prevalence of sickle cell disease and the rising number of hospital admissions for treatment. Specialty clinics are also expected to grow significantly during the forecast period, which could further boost the demand for drugs like SIKLOS[1].

Geographic Market Dynamics

The U.S. dominates the global sickle cell disease treatment market, holding a significant share of 64% in 2022. This dominance is attributed to better access to treatment, potential pipeline candidates, strong government support, and rising collaborations to improve treatment. Europe also accounts for a significant market share and is projected to witness considerable growth during the forecast period due to favorable reimbursement policies and increasing prevalence of the disease[1].

Competitive Landscape

The market for sickle cell disease treatment is competitive, with key players such as Global Blood Therapeutics Inc. (Pfizer Inc.), Novartis AG, and Emmaus Medical, Inc. These companies have captured a considerable market share and are driving innovation in SCD therapeutics. The strong sales of drugs like Oxbryta by Global Blood Therapeutics Inc. and the presence of other effective treatments contribute to the competitive landscape in which SIKLOS operates[1].

Financial Performance and Projections

Given the overall growth of the sickle cell disease treatment market, the financial performance of SIKLOS is expected to be robust. The increasing prevalence of sickle cell disease, rising awareness, and government support for new drug launches are key drivers. As the pharmacotherapy segment grows, SIKLOS, being a part of this segment, is likely to see increased demand and revenue.

Key Takeaways

  • Market Growth: The global sickle cell disease treatment market is projected to grow significantly, driven by the pharmacotherapy segment.
  • Government Support: Strong government initiatives and funding support the launch of new pharmacotherapy drugs.
  • Distribution and Marketing: SIKLOS is exclusively marketed and distributed in the U.S. by Medunik USA.
  • COVID-19 Impact: The pandemic had a mixed impact, but pharmacotherapy segments remained relatively stable.
  • Geographic Dynamics: The U.S. and Europe are key markets, with significant growth expected in these regions.
  • Competitive Landscape: The market is competitive, with major players driving innovation and sales.

FAQs

  1. What is SIKLOS used for?

    • SIKLOS (hydroxyurea) is used to reduce the frequency of painful crises and the need for blood transfusions in patients with sickle cell anemia.
  2. Who distributes SIKLOS in the United States?

    • SIKLOS is distributed in the United States by Medunik USA, through an exclusive agreement with ADDMEDICA.
  3. How has the COVID-19 pandemic affected the market for SIKLOS?

    • The pandemic had a mixed impact, with the pharmacotherapy segment remaining relatively stable but other segments like blood transfusions and bone marrow transplants seeing a decline.
  4. What are the key drivers of the sickle cell disease treatment market?

    • The key drivers include the increasing prevalence of sickle cell disease, rising awareness, and government support for new drug launches.
  5. Which regions dominate the global sickle cell disease treatment market?

    • The U.S. and Europe dominate the market, with the U.S. holding a significant share due to better access to treatment and strong government support.

Sources

  1. Fortune Business Insights - Sickle Cell Disease Treatment Market Size & Analysis [2030]
  2. Shionogi Inc. - Future - Shionogi Inc. (Annual Report)
  3. IQVIA - Understanding the Dynamics of Drug Expenditure
  4. Fortune Business Insights - Sickle Cell Disease Treatment Market | CAGR of 20.1%
  5. Sickle Cell Information - Sickle Cell News for September 2018

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