Prevnar 13 market launch date?

What year did Prevnar 13 first become available in the US market?

Prevnar 13, a pneumococcal conjugate vaccine, was first approved by the US FDA on October 27, 2010 [1]. It was developed by Pfizer.

How does the market launch timeline compare to other pneumococcal conjugate vaccines like Pneumovax 23?

Prevnar 23, a predecessor vaccine that protected against 23 serotypes, had been widely used since 2000. Pneumovax 23 is still used to protect people over the age of 64 who do not have a weakened immune system. However, the introduction of Prevnar 13 aimed to extend the vaccine's protection to younger adults [2].

When does patent protection for Prevnar 13 begin to expire?

The patent for Prevnar 13's vaccine technology and manufacturing process expired in 2016 [3], enabling generic versions to become available. However, some patents protecting the vaccine's formulation, labeling, and packaging continue to limit generic entry. According to DrugPatentWatch.com, several patents protecting Prevnar 13 will not expire until 2027 at the earliest [4].

What regulatory challenges have impacted the patent landscape for Prevnar 13?

Pfizer's research and development of Prevnar 13 led to significant patent filings to protect the technology, which in turn has been the subject of patent challenges and legal disputes over the years.

References:
[1] https://www.fda.gov/media/129129/download
[2] https://www.pneumovax23.com/
[3] https://www.drugpatentwatch.com/patent/US-7749444
[4] https://www.drugpatentwatch.com/patent/US-7749444