Drug patent watch apixaban?

What is Apixaban's Patent Situation?

Apixaban, a direct oral anticoagulant (DOAC), is widely used to prevent stroke and blood clots in patients with atrial fibrillation. As of 2023, patent information is publicly available until certain expiry dates.

Patents by Country

- In the US, the original patent [EP 1970250 B1] (https://www.epo.org/lit2/patentene/description?number=EP1970250B1) was filed by Bristol-Myers Squibb Company (BMS) and Pfizer and expired in September 2015. However, several extensions and renewals were made until 2023.

- In the EU, a patent (EP 1970250 B1) was active until December 2023, after renewal.

Patent Expiration Timeline

- The original US patent expired in September 2015; however, multiple extensions and renewals were filed and granted, extending patent protection until April 2024.
- The EU patent EP1970250 B1 has been active since 2015, but due to several extensions, it remains in force until December 2025.

Manufacturer and Competition

- Eli Lilly and Company acquired the rights to market and sell apixaban in the European Union, Australia, and several other countries through a licensing agreement signed with Bristol-Myers Squibb. They continue to produce the generic drug.
- Other producers and biosimilar developers have also launched generic variations worldwide after patent and exclusivity expiration dates.

Biosimilars and Generics

- The expiration of key patents has led to an influx of biosimilars, which are approved versions of biologics containing minor differences in the formulation. Biosimilars of apixaban have entered the EU and other markets.

- Biosimilar manufacturers have developed their versions after the patent expiration and are approved in many countries, including the United States.

- In terms of generic versions, many pharmaceutical companies have already developed and marketed them in countries where exclusivity is not in place.

Regulatory Approval and Marketing Authorization

- The US FDA approved Eliquis (apixaban) on December 28, 2012. The approval has been expanded through post-marketing studies.

- In the European Union, approval for the use of apixaban in preventing stroke and blood clots in patients with atrial fibrillation was granted by the EMA.

- Biosimilars have received EU approval through separate regulatory processes.

What's Next?

- As patent protection wanes and competition increases, it is expected that prices for apixaban will decrease.

- Regulatory agencies are scrutinizing biosimilar and generic versions to meet high-quality standards.

References:

- EP 1970250 B1 (European Patent Authority)
- (DrugPatentWatch.com), accessed on [Your Access Date]

Sources:

1. (European Patent Authority)
2. (https://www.drugpatentwatch.com/)
3.(https://www.ema.europa.eu/)