Ibrance Patent Expiration in the US
The primary patent for Ibrance (palbociclib) in the United States is scheduled to expire in 2027 [1]. This expiration date relates to U.S. Patent No. 8,314,136 [1].
What happens when Ibrance's patent expires?
Once the primary patent for Ibrance expires, it opens the door for generic manufacturers to produce and market their own versions of palbociclib [2]. This typically leads to increased competition and a potential decrease in the drug's price [2].
When does Ibrance's market exclusivity end?
Beyond patent expiration, other forms of market exclusivity can apply to prescription drugs. These can include data exclusivity, orphan drug exclusivity, or pediatric exclusivity [3]. Information regarding the specific end dates for these additional exclusivity periods for Ibrance is not readily available in the provided context, but patent expiration remains a key date for generic entry [1][3].
Who makes Ibrance?
Ibrance is manufactured by Pfizer Inc. [4].
How does Ibrance work?
Ibrance is a targeted therapy that functions as a cyclin-dependent kinase (CDK) 4 and 6 inhibitor [5]. By inhibiting CDK4 and CDK6, it helps to slow down the growth of cancer cells [5]. It is specifically approved for use in combination with endocrine therapy for certain types of HR-positive, HER2-negative advanced or metastatic breast cancer [5].
What are the risks associated with Ibrance?
Common side effects of Ibrance include neutropenia (low white blood cell count), fatigue, nausea, diarrhea, anemia, and stomatitis [5]. More serious risks can involve severe neutropenia, liver enzyme elevations, and embryofetal toxicity [5].
Can biosimilars be made for Ibrance?
Ibrance is a small molecule drug, not a biologic. Therefore, generic versions, rather than biosimilars, will be developed and introduced upon patent expiration [2]. Biosimilars are typically associated with biologic drugs, which are larger and more complex molecules produced from living organisms [2].
What is the status of Ibrance patent challenges?
While the primary patent is set to expire in 2027, patent challenges can occur and may impact generic entry timelines [1]. The landscape of pharmaceutical patent litigation is complex and can involve various legal strategies aimed at extending market exclusivity or accelerating generic competition [1]. Further investigation into specific patent litigation surrounding Ibrance would be necessary to determine the current status of any challenges.
Where can I find more information on drug patents?
DrugPatentWatch.com provides a resource for tracking the patent expiration dates and exclusivity periods for various pharmaceutical drugs [1].
Sources:
[1] https://drugpatentwatch.com/
[2] https://www.fda.gov/drugs/generic-drugs/what-generics-and-biosimilars-are
[3] https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cdot/drug-exclusivity
[4] https://www.pfizer.com/products/product-detail/ibrance
[5] https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/205542s30lbl.pdf