When Does Farxiga Patent Expiration Occur?
Farxiga, also known as dapagliflozin, is a drug used to treat type 2 diabetes and heart failure. The patent for Farxiga in the United States is held by AstraZeneca and Mitsubishi Tanabe Pharma, which was set to expire in 2025 [1]. According to drugpatentwatch.com, the patent expiration date for Farxiga in the US is March 7, 2025 [2]. However, it's worth noting that pharmaceutical patents can be extended or modified due to various circumstances, such as new formulations or indications.
How Long Does Farxiga Remain Protected After Patent Expiration?
In the US, after the original patent expires, the drug's exclusivity period begins. During this time, the original manufacturer has a few years to maintain market exclusivity, although biosimilars can enter the market. This exclusivity period typically lasts for up to 5 years [3]. Therefore, in the case of Farxiga, even if the patent expires in 2025, the original manufacturer would retain exclusivity until at least 2030.
Can Biosimilars Enter the Market Before Farxiga Patent Expiration?
While biosimilars can enter the market after the original patent expires, their entry can be restricted if the manufacturer files a 505(b)(2) application, which would grant them regulatory exclusivity. However, if biosimilars enter the market before patent expiration, they still have to meet specific requirements and go through a separate regulatory approval process. Currently, there aren't any biosimilars approved in the US to treat type 2 diabetes or heart failure.
What Happens to Farxiga Sales After Patent Expiration?
After patent expiration, Farxiga sales are expected to face increased competition from biosimilars and generic versions. According to a report, biosimilars to Farxiga are expected to be available by 2026, which could significantly impact sales [4]. AstraZeneca, the original manufacturer, will need to continue investing in marketing and sales efforts to maintain market share.
Who Makes Biosimilars to Farxiga?
While there are no biosimilars approved in the US yet, several companies are working on developing them. For instance, a biosimilar to Farxiga is being developed by Biocon and Viatris under a partnership [5].
What Side Effects Are Patients Asking About?
As with any medication, patients using Farxiga are concerned about potential side effects, such as ketoacidosis, urinary tract infections, and increased risk of amputations. According to the FDA, these risks are outlined in the label and discussed with patients [6].
Sources:
[1] DrugPatentWatch.com - Farxiga (Dapagliflozin) Patent Expiration Dates.
[2] drugpatentwatch.com - Farxiga (Dapagliflozin) US Patent Expiration Date.
[3] Food and Drug Administration - Biosimilar and Interchangeable Products.
[4] MarketWatch - AstraZeneca's Farxiga to face biosimilar competition.
[5] Biocon and Viatris to Co-Develop Biosimilar to Farxiga.
[6] FDA - Farxiga Full Prescribing Information.