API and IP Newsletter
Contents
FDA approvals in January 2021.
General information.
Reported ANDA litigation settlements in district court cases
Indian pharma industry expected to grow to $65 billion by 2024.
Intellectual Property.
Valent Vs Zydus Claim construction.
FDA approvals in January 2021
In this write-up we would evaluate synthetic APIs.
Cabotegravir
PCT application WO 2006/116764 published on 2 November 2006, where the reaction depicted at page 80 from 16 to 17-1, could be a potential synthesis for Cabotegravir. A second reaction scheme is on page 113 of WO 2006/116764.
One more synthesis is reported as example A in WO2010/068253A1. This is a summary, but a lot of work has gone into the synthetic chemistry of Cabotegravir.
Major raw material (RM) would be Methyl 4-methoxyacetoacetate. It is a common RM for Dolutegravir. One can expect that all Dolutegravir suppliers will extend their portfolio of antiretrovirals by offering Cabotegravir in future. Vivian, Mylan, Styrax and Honour are importing Methyl 4-methoxyacetoacetate in huge quantities (maybe for Dolutegravir) and these could be potential suppliers of Cabotegravir.
General information
Reported ANDA litigation settlements in district court cases
This chart in the news article summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed pursuant to the Hatch-Waxman Act. (Read more)
Indian pharma industry expected to grow to $65 billion by 2024
The drug industry, which is currently valued at $41 billion, is expected to grow to $65 billion by 2024 and $120-130 billion by 2030. (Read more)
Intellectual Property
Valent Vs Zydus Claim construction
The case was in District Court of New Jersey and about Claim Construction for Efinaconazole topical solution marketed product, and specifically regarding claimed applicator reported in US 10,478,601.
Efinaconazole topical solution, 10%, is indicated for the topical treatment of onychomycosis of the toenail(s) due to trichophyton rubrum and trichophyton mentagrophytes. Efinaconazole topical solution, 10%, had estimated annual sales of USD 222.9 million in the US, according to IQVIA MAT September 2020.
Orange book patents:
The chart below sets forth the parties’ proposed constructions.
The Court defined the disputed claim term “bottom portion” to mean “the lateral surface that is bonded to the tubular body,” and “tip portion” to mean “the fan-shaped end of the columnar brush member.”
This case is reported by Pharmacircle here.
Teva and Perrigo had already sought the approval, for them this must be a later listed patent, and hence they did not have to certify against `601.
Disclaimer
Sidvim LifeSciences Private Ltd has taken due care and caution in developing this document. Since the data used for analysis in this document is based on the information available in the public domain, its adequacy or accuracy or completeness cannot be guaranteed. This document is for information only and Sidvim is not responsible for losses that may or may not arise due to any decisions made based on the same. No part of the document shall constitute or be represented as a legal opinion of any kind or nature. No warranties or guarantees, expressed or implied, are included in or intended by the document, except that it has been prepared in accordance with the current generally accepted practices and standards consistent with the level of care and skill exercised under similar circumstances by professional consultants or firms that perform the same or similar services.
