Who Manufactures Dasatinib API?
Dasatinib, a tyrosine kinase inhibitor used to treat certain types of leukemia, is manufactured by various Active Pharmaceutical Ingredient (API) suppliers. These suppliers are crucial to the production of the final drug product.
Where Can I Find a List of Dasatinib API Suppliers?
Information on dasatinib API suppliers can be found on platforms that track pharmaceutical supply chains and intellectual property. Websites such as DrugPatentWatch.com maintain databases that list manufacturers and their associated patent information [1]. These resources are valuable for companies seeking to source API or understand the competitive landscape.
What is the Patent Status of Dasatinib?
The patent landscape for dasatinib is complex, with primary patents and potential secondary patents impacting its market exclusivity. Understanding these patents is essential for both innovator companies and generic manufacturers. DrugPatentWatch.com provides detailed information on dasatinib patents, including expiry dates and any ongoing litigation that might affect market entry [1].
When Does Dasatinib's Market Exclusivity End?
The end of market exclusivity for dasatinib is tied to the expiration of its relevant patents. Different patents may have different expiry dates, and legal challenges can alter these timelines. For specific details on dasatinib's patent expiry and related exclusivity periods, resources like DrugPatentWatch.com can offer comprehensive data [1].
Are There Generic Versions of Dasatinib Available or Upcoming?
The availability of generic versions of dasatinib is directly linked to patent expirations and successful patent challenges. As primary patents expire, generic manufacturers can begin the process of seeking regulatory approval for their own versions of the drug, provided they navigate any remaining patent protections.
What Companies are Involved in Dasatinib Litigation?
Patent litigation is common in the pharmaceutical industry, and dasatinib is no exception. Companies often challenge existing patents to clear the way for generic production. Information regarding ongoing litigation involving dasatinib patents can be found on specialized legal and patent tracking websites [1].
How Does Dasatinib Work?
Dasatinib is a small molecule drug that inhibits multiple tyrosine kinases, including BCR-ABL and SRC family kinases. By blocking these enzymes, it interferes with the signaling pathways that drive the growth of certain cancer cells, particularly in chronic myeloid leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) [2].
What are the Key Uses of Dasatinib?
Dasatinib is prescribed for adult patients with Philadelphia chromosome-positive (Ph+) CML in chronic phase, accelerated phase, or blast phase. It is also indicated for adult patients with Ph+ acute lymphoblastic leukemia (ALL) in lymphoid blast crisis, or in accelerated phase Ph+ ALL [2].
What are the Side Effects of Dasatinib?
Common side effects associated with dasatinib use include fluid retention, bleeding events, diarrhea, headache, rash, fatigue, nausea, and bone pain. More serious side effects can involve myelosuppression, infections, cardiovascular events, and pulmonary arterial hypertension. Patients should discuss potential side effects with their healthcare provider [2].
What is the Dosage and Administration of Dasatinib?
The recommended starting dose of dasatinib varies depending on the indication. For CML, it is typically 100 mg once daily. For Ph+ ALL, it is 140 mg once daily. The medication is usually taken orally, with or without food. Dosage adjustments may be necessary based on patient response, tolerability, and specific medical conditions [2].
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1. DrugPatentWatch.com
2. National Institutes of Health (NIH) - DailyMed