API and IP Newsletter
Contents
New AI collaborations reflect rapid growth in pharmaceutical industry
Johnson and Johnson is going to spin off Consumer Health Business
FDA approvals September 2021
We analyse FDA approvals each month. Atogepant is one of the small molecule approved in September.
Compound 51 of patent family WO2013169348A1 issued to Merck Sharp & Dohme (MSD) relates to atogepant. Basic atogepant compound is covered in WO2012064910A1 family and will be valid till 2032.
As per FDA label, atogepant (QULIPTA), a calcitonin gene-related peptide (CGRP) receptor antagonist. The chemical name of atogepant is (3'S)-N-[(3S,5S,6R)-6-methyl-2-oxo-1- (2,2,2-trifluoroethyl)-5-(2,3,6-trifluorophenyl)piperidin-3-yl]-2'-oxo-1',2',5,7- tetrahydrospiro[cyclopenta[b]pyridine-6,3'-pyrrolo[2,3-b]pyridine]-3-carboxamide.
Atogepant is a white to off-white powder. It is freely soluble in ethanol, soluble in methanol, sparingly soluble in acetone, slightly soluble in acetonitrile, and practically insoluble in water. QULIPTA is available as tablets for oral administration containing 10 mg, 30 mg, or 60 mg atogepant.
Hetero is importing RMs such as derivatives of (3-AMINO-6-METHYL-5-PHENYL-1-(2,2,2-TRIFLUOROETHYL)-2-PIPERIDINONE) from China in couple of kilogram quantities. The last shipment was in in August 2021. It means Hetero must have started development of atogepant long before the approval and one can expect DMF filing soon by Hetero!
Glenmark, Aurobindo, Biphore and GMK are also ordering same/similar intermediates from China. However, kilogram quantities of these derivatives are being ordered only by Hetero and Biophore and they could be ahead of the competition in DMF filing. However, it seems many companies are working on atogepant and there could be few DMFs filed in the year 2022.
General information
New AI collaborations reflect rapid growth in pharmaceutical industry
Artificial intelligence is becoming the darling of the biopharma industry after years of testing and discussion. As the capabilities have been proven, AI is establishing a firm foothold in the key areas of R&D, drug development, clinical trials and, to some extent, patient-facing products.
Announcements of new AI deals, partnerships and product launches in biopharma are coming at a rapid pace. A new report from Research and Markets, AI In Pharma Global Market Opportunities and Strategies to 2030: COVID-19 Growth and Change, predicts this segment will grow from almost $699.3 million in 2020 to more than $2.895 billion in 2025.
News here.
Johnson and Johnson is going to spin off Consumer Health Business
Johnson & Johnson (JNJ.N) plans to spin off its consumer health division that sells Listerine and Baby Powder to focus on pharmaceuticals and medical devices in the biggest shake-up in the U.S. company's 135-year history.
News here.
Intellectual Property
Generic launches of empagliflozin in India
Dr. Reddy’s Lab and MSN launched generic versions of empagliflozin in October 2021. Boehringer Ingelheim (BI) sued generic companies after launches.
BI imported about Rs 366 Cr worth empagliflozin in 2020-21.
Below is the data which BI submitted to patent office. The cost of 1 pill of 10 Mg or 25 MG empagliflozin of BI is about Rs. 35-37, whereas price of 1 pill of DRL is about Rs. 15-18.
Empagliflozin covered by a granted patent IN 268846 (patent family WO 2005 092877), fees paid till 2021 and patent would expire in 2024.
After Gx launches (DRL and MSN), BI moved the court to restrain generics from marketing and HP High Court granted an injunction in favour of BI against MSN and DRL till the date of next hearing. DRL further directed to remove the impugned product from its website or any other websites.
News 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.
