DUBLIN--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/44rsbx/generic_drug) has announced the addition of the "Generic Drug Opportunity Assessment - Eltrombopag (Promacta)" report to their offering.
Promacta (eltrombopag) tablets contain eltrombopag olamine, a small molecule thrombopoietin (TPO) receptor agonist for oral administration. Eltrombopag was discovered as a result of research collaboration between Glaxo and Ligand. Eltrombopag interacts with the transmembrane domain of the TPO receptor (also known as cMpl) leading to increased platelet production. Eltrombopag is marketed under the brand names Promacta in the U.S. and Revolade in Europe and rest-of-World. The drug is approved in 90 countries as a treatment for thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura, or ITP. In the U.S., Promacta is already indicated for the treatment of thrombocytopenia in patients with chronic ITP who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy.
Immune thrombocytopenic purpura (ITP) is a disorder that can lead to easy or excessive bruising and bleeding. The bleeding results from unusually low levels of platelets, the cells that help the blood clot. ITP affects both children and adults. Promacta is indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
In November 2012, the FDA granted approval to Promacta for a new indication for treatment of thrombocytopenia -low blood platelet counts- in patients with chronic hepatitis C to allow them initiate and maintain interferon-based therapy. The approval makes Promacta the first supportive care treatment available to patients who are ineligible or poor candidates for interferon-based therapy due to low blood platelet counts.
Nplate (romiplostim), supplied by Amgen, was the first biotherapeutic to get approved for the treatment of low blood platelet counts in adults with chronic immune thrombocytopenia. In August 2008, the FDA approved Nplate for the treatment of thrombocytopenia in splenectomized (spleen removed) and nonsplenectomized adults with chronic immune thrombocytopenic purpura (ITP). Nplate works by raising and sustaining platelet counts. Amgen was granted an exclusive license by Kirin-Amgen to manufacture and market Nplate in the United States, all European countries, Canada, Australia, New Zealand, Mexico, all Central and South American countries and certain countries in Central Asia, Africa and the Middle East. In February 2009, the EC granted marketing authorization for Nplate for the treatment of splenectomized adult chronic ITP patients who are refractory to other treatments (e.g., corticosteroids, immunoglobulins).
Therapeutic Sector P (IV) Activity
Until recently, the cardiovascular drug sector has been quite active with regard to ANDA filings, with P (IV) certifications averaging about five per year from 2006 - 2010. This trend reflects the fragmented therapeutic environment. We expect the rate of P (iV) certifications to increase through 2018, as brand drugs lose exclusivity and patent protection.
- Promacta - The Brand
- Eltrombopag - The Product
- Eltrombopag - The Market
- Eltrombopag - The Opportunity
- Manufacturing and Sourcing
- Promacta Patents and Exclusivity
- Therapeutic Class P4 Certifications
- Generic First-to-File Revenue Opportunity
- Business Risk Assessment
- First-to-File - Probabilistic Scenario
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