API and IP Newsletter
Content
DMFs filed in the month of May 2021.
General information.
Purdue University & US Pharmacopeia Launch Pharmaceutical Industry Technology Forum..
Bayer Sees A Golden Age For China’s Pharmaceutical Market
Intellectual Property.
Access to generic companies for product samples.
DMFs filed in the month of May 2021
In SIDVIM, we analyze DMFs filed by generic companies. This month we analysed DMFs filed in May 2021. There are about 70 DMFs filed. Glimpses of our analysis is as below:
General information
Purdue University & US Pharmacopeia Launch Pharmaceutical Industry Technology Forum
The forum will begin with a one-hour introduction session on September 14, 2021 and will continue monthly into 2022. (Read more)
Bayer Sees A Golden Age For China’s Pharmaceutical Market
Bayer has business locations in 83 countries around the world. Bayer’s sales in Greater China last year were hurt by fallout from Covid-19, sliding 5-6% to 3.48 billion euros. (Read more)
Intellectual Property
Access to generic companies for product samples.
The CREATES Act
CREATES establishes a private right of action that allows developers to sue brand companies that refuse to sell them product samples needed to support their generic applications (such as ANDA). If the product developer (Generic applicant) prevails, the court will order the sale of samples, award attorneys’ fees and litigation costs to the product developer and may impose a monetary penalty on the brand company. Details of the law could be read at the FDA website here.
The law was enacted in December 2019.
Migalastat, sold under the brand name Galafold, is a medication for the treatment of Fabry disease, a rare genetic disorder. It was developed by Amicus Therapeutics. Sales was about $ 260 mio in 2020.
Teva wanted to develop a generic version. Teva submitted an initial request to Amicus seeking to purchase two wallet packs of GALAFOLD® (each containing 14 capsules) on 5 August 2020.
Teva sent a second request to Amicus dated 29 March 2021. That request sought twenty-five additional wallet packs to complete required analytical and bioequivalence testing.
Amicus delivered the two wallet packs of GALAFOLD® (migalastat) to Teva on 27 April 2021, more than six months after the deadline specified in the CREATES Act for compliance. Amicus then responded to Teva’s second request by simply refusing to provide the twenty-five additional packs of GALAFOLD® that Teva sought. Amicus raised a number of specious arguments as to why Teva was not entitled to these twenty-five additional packs, and unilaterally stated that it would furnish only two more wallet packs to Teva. Amicus’ refusal to provide the requested quantity of GALAFOLD®, which Teva had determined was necessary to allow Teva to conduct testing to support approval of its planned ANDA, violates the CREATES Act.
Teva sued Amicus Therapeutics, alleging the company refused to supply samples of its high-priced branded drug, Galafold
Teva’s action here
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.
