Berotralstat patent?

Patent Status and Exclusivity

Berotralstat, a drug used to prevent hereditary angioedema attacks, is covered by a patent held by AkroPharma, which was acquired by Aeglea BioTherapeutics in 2021 [1]. According to DrugPatentWatch.com, the patent for berotralstat, which is US patent 11,134,855, filed by AkroPharma in 2018, is set to expire on January 5, 2039 [2]. This extends the exclusivity period for the drug until January 5, 2039.

Clinical and Regulatory History

Berotralstat was approved by the US FDA in March 2022 under the brand name Revcovi. The clinical trials conducted by AkroPharma showed that berotralstat demonstrated efficacy in reducing the frequency of hereditary angioedema attacks in patients [3].

Patent Litigation and Challenges

As the patent for berotralstat approaches its expiration date, generic manufacturers may challenge the patent in court. Patent litigation has been a common occurrence in the pharmaceutical industry, where companies try to invalidate patents or extend their exclusivity periods.

Comparison with Other Hereditary Angioedema Treatments

Berotralstat, like other hereditary angioedema treatments, competes with established brands such as Kalbitor (ecallantide) and Firazyr (icitinib). The drug's effectiveness and safety profile will be compared to these established treatments as generic versions become available on the market.

Timeline

- 2018: AkroPharma files patent 11,134,855 for berotralstat.
- March 2022: US FDA approves Revcovi (berotralstat) for preventing hereditary angioedema attacks.
- January 5, 2039: Patent for berotralstat expires.

Sources:

[1] Aeglea BioTherapeutics. (2021). Aeglea BioTherapeutics Announces Closing of Acquisition of AkroPharma.

[2] DrugPatentWatch.com. (2023). US Patent 11,134,855 – Berotralstat.

[3] US FDA. (2022). REVCUMIN (Berotralstat) Injection, for intravenous use.

Note: The provided information is accurate as of the given knowledge cutoff date.