Welcome to “A to Z: Drugs in Highlight
This series is designed to delve into the intricate realm of pharmaceutical drugs. As the world of pharmaceuticals continues to evolve with new discoveries and emerging challenges, we aim to shed light on the diverse array of medications available today, ranging from blockbuster medications to those that may not be as familiar. Whether you’re a healthcare professional, a student, or simply someone with a curious mind, “A to Z: Drugs in Highlight” promises to be an enlightening and engaging series.
P is for PAXLOVID®
PAXLOVID® is an oral antiviral medication developed by Pfizer to treat mild-to-moderate COVID-19 in adults who are at high risk of progressing to severe illness.
How it works:
PAXLOVID® consists of two active ingredients: nirmatrelvir and ritonavir.
- Nirmatrelvir inhibits the 3C-like protease enzyme of the SARS-CoV-2 virus (the virus that causes COVID-19), which is essential for the virus to replicate. By blocking this enzyme, nirmatrelvir effectively stops the virus from multiplying within the body.
- Ritonavir helps boost the effectiveness of nirmatrelvir by slowing its breakdown in the liver.
The recommended dose is two tablets, each containing 150 mg nirmatrelvir, plus one tablet containing 100 mg ritonavir, to be taken together by mouth twice a day for 5 days. It has been reported that PAXLOVID® can reduce the risk of hospitalization or death by 88% if taken within five days of symptom onset.
Market impact:
Despite its effectiveness, PAXLOVID® has faced challenges in market uptake. Factors such as cost barriers and concerns about drug interactions have affected its widespread use. However, PAXLOVID® remains a crucial treatment option for high-risk COVID-19 patients and is now a major revenue driver for Pfizer.
PAXLOVID® is approved for marketing in the United States and Europe. PAXLOVID® transitioned from emergency use authorization to full U.S. Food and Drug Administration (FDA) approval in May 2023. PAXLOVID® was approved by the European Medicine Agency (EMA) in January 2022 and by the Medicines & Healthcare products Regulatory Agency (MHRA) in December 2021.
Patent protection:
There are patent rights protecting various aspects of PAXLOVID® in the United States and Europe. For example, US11351149B2 protects nirmatrelvir. It relate relates to the compound (1R,2S,5S)-N-{(1S)-1-Cyano-2-[(3S)-2-oxopyrrolidin-3-yl]ethyl}-6,6-dimethyl-3-[3-methyl-N-(trifluoroacetyl)-L-valyl]-3-azabicyclo[3.1.0]hexane-2-carboxamide having the structure
or a solvate or hydrate thereof.
US11541034B2 relates to a method of treating coronavirus infection in a patient, the method comprising co-administering a therapeutically effective amount of the nirmatrelvir, and ritonavir to the patient.
EP3953330B1 and EP4166539B1 provide a similar scope of protection in Europe.
In November 2021, Pfizer entered into a voluntary license agreement with the Medicines Patent Pool (MPP) to facilitate affordable access to PAXLOVID®. Under the terms of the license agreement, qualified generic medicine manufacturers worldwide that are granted sub-licenses can supply PAXLOVID® to 95 countries (including all low- and low-middle income countries and some upper-middle income countries), covering up to approximately 53% of the world’s population.
Patent support from Secerna
Our team has a wealth of experience gained from working with world leaders in the chemistry and pharmaceutical disciplines encompassing new chemical entities, materials science, agricultural chemistry, chemical processes and formulation technology. We have also worked extensively in the medical device materials and carbon nanotechnology sectors.
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