What is Orfegalipt (or Orfegalipt)?
Orfegalipt, also known as [Org 34517], is a medication developed by Organon International (now part of Merck) for the treatment of respiratory diseases such as chronic obstructive pulmonary disease (COPD) [1]. It works by inhibiting the pro-inflammatory action of IL-1β and IL-6 cytokines.
Patent Status and Exclusivity
According to the Orange Book database and DrugPatentWatch.com, the original New Drug Application (NDA) for Orfegalipt, filed by Organon, was approved in 2001 [2]. The NDA included a patent covering the compound's use in treating respiratory diseases. This patent, US Patent 6,479,547, issued in 2002, is set to expire in 2019.
However, subsequent patent applications for Orfegalipt's use in various therapeutic areas were granted. For instance, US Patent 9,341,654, filed in 2016 and covering additional uses for Orfegalipt in respiratory disease, is scheduled to expire in 2036.
Generic Orfegalipt Availability and Patent Exclusivity Status
Generic versions of Orfegalipt may enter the market once the relevant patents expire. Currently, there are no generic versions of Orfegalipt approved by the US FDA, primarily due to the ongoing patent protection for the original drug.
Patent Expiry Dates and Potential Impact on Availability
To confirm the current patent status and potential expiry dates:
- The patent (US Patent 6,479,547) originally covering Orfegalipt expired in 2019.
- US Patent 9,341,654, covering additional respiratory uses, expires in 2036.
Keep in mind that patent expiration dates may change over time due to various factors, such as settlements or modifications involving patent applications or existing patents. These changes can lead to the earlier availability of generic versions of Orfegalipt.
References:
[1] - Organon International and Merck KGaA. (2001). New Drug Application (NDA) for Org 34517 (Orfegalipt).
[2] - DrugPatentWatch.com - Org 34517 (Orfegalipt, Orfegalipt, Orfegalipt) https://drugpatentwatch.com/orfegalipt
Sources:
1. DrugPatentWatch.com- https://drugpatentwatch.com/