Contents
Analysis of DMFs filed in November 2020
This week we would analyse DMFs filed by Indian companies in October 2020. About 59 DMFs filed in the month of November 2020 and 31 of those are from Indian companies.
Sidvim analysis is in below table.
HOLDER | SUBJECT | SIDVIM Comments |
TEVA PHARMACEUTICAL INDUSTRIES LTD | SAXAGLIPTIN HYDROCHLORIDE (DIHYDRATE) | This could have been filed by Indian entity of Teva. BMS has claimed many crystalline forms in WO2008131149A2. Most of the applications in this family are being abandoned. Generics are developing many forms claimed in this family. |
MICRO LABS LTD | ESCITALOPRAM OXALATE USP | Vanilla generics, several DMFs, but only Hetero and Cipla are actively exporting to US @ around USD 550/Kg. |
ALEMBIC PHARMACEUTICALS LTD | CLOFARABINE | Many DMFs, many ANDA filers. |
TEVA PHARMACEUTICAL INDUSTRIES LTD | MEMANTINE HYDROCHLORIDE 7SM1037 | Many DMFs. Teva had form H patent in US, which is abandoned in US, but active in some other countries. This form could be prepared as per described in WO2006076560A1 by Teva. DRL, MSN are main suppliers to US and selling in the range of USD 1000-1350/Kg. |
MSN LABORATORIES PRIVATE LTD | BARICITINIB | One of the first DMFs for Baricitinib, Gx launch looks difficult before 2029! But it indicates, someone must be active in filing ANDA. Natco, Aurobindo, Neuland and MSN are importing formulations must be innovator samples for ANDA development? |
ALEMBIC PHARMACEUTICALS LTD | TEGASEROD MALEATE | Only DMF! Tegaserod) had originally received approval from the US FDA in 2002 for the treatment of irritable bowel syndrome with constipation. Zelnorm (Tegaserod) by Sloan Pharma subsequently gained re-approval in April of 2019. Despite, challenges Tegaserod remains the only therapy for IBS-C. This could be good molecules for Gxs |
HARMAN FINOCHEM LTD | FOSPROPOFOL DISODIUM | Only DMF! Fospropofol was discontinued in the USA in 2018; the likely reasons include its delayed onset of effect. It is interesting to note this DMF filing! Who is accessing this DMF for discontinued product! |
MSN LABORATORIES PRIVATE LTD | DIAZOXIDE USP | Biophore is only other Indian company to file DMF. Few ANDA files for this old product. |
CADILA HEALTHCARE LTD | ALBENDAZOLE USP | Recently lot of interest in Albendazole by Cipla, MSN and other companies! To be investigated. Maybe there was a noise about antiparasitic drugs and its effectiveness against Covid-19? |
METROCHEM API PRIVATE LTD | ESOMEPRAZOLE MAGNESIUM TRIHYDRATE | Generic API |
METROCHEM API PRIVATE LTD | RABEPRAZOLE SODIUM | Generic API |
DASAMI LAB PRIVATE LTD | DROXIDOPA (PROCESS-II) | Many DMFs, Dusami formerly Medchem Organics Pvt. Ltd. The company has more than a dozen active DMFs, filed in last 3 years! |
TEVA PHARMACEUTICAL INDUSTRIES LTD | RIBOCICLIB SUCCINATE | Going to be very crowded market. Three DMFs within 3 years of approval! |
TEVA PHARMACEUTICAL INDUSTRIES LTD | MIDOSTAURIN | 2017 approvals and 3 DMFs already. Novartis molecule catching lot of attention of Gx. |
CHROMO LABORATORIES INDIA PRIVATE LTD | LINEZOLID USP | Many DMFs, more than 20 DMFs active. |
CADILA HEALTHCARE LTD | DIROXIMEL FUMARATE | 2019 approval and already 3 DMFs. Very simple small molecule. Once can expect too many NCE-1 filing in 2023! |
RA CHEM PHARMA LTD |
PIRIBEDIL | Not many Gx and DMFs active. Seems interesting, to be investigated. |
GRANULES INDIA LTD | DASATINIB | Too many DMFs, Granules is one among many. |
CHROMO LABORATORIES INDIA PRIVATE LTD | RITONAVIR USP | Many DMFs since 1996. But suddenly 4 DMFs filed in last 2 years. Something must be going on in Ritonavir. One should study in detail! |
METROCHEM API PRIVATE LTD | OMEPRAZOLE MAGNESIUM | Vanilla generic |
INNOVARE LABS PRIVATE LTD | VORICONAZOLE USP | About dozen active DMFs. Innovare would be one among them. |
HETERO DRUGS LTD | DEUTETRABENAZINE | 2017 approval and 5 DMFs already filed! One can expect few filers on NCE-1 date. |
APICORE LLC | FLIBANSERIN | Surprisingly only one DMF filed so far for 2015 approved molecule. Development was halted in 2010 due to side effects, later sought approval in 2015. Maybe Gx are not very keen in working on this molecule. Good selection by Apicore for 2022-23 launch possibilities in US. |
AURO PEPTIDES LTD | ETELCALCETIDE HYDROCHLORIDE | Generic launch appears difficult till 2030. MSN had already filed DMF. |
SUNPURE EXTRACTS PVT LTD | CISSUS QUADRANGULARIS EXTRACT | Natural product |
SUNPURE EXTRACTS PVT LTD | MONOAMMONIUM GLYCYRRHIZINATE | Glycyrrhizic Acid is a natural material isolated from the licorice plant |
SYMBIOTEC PHARMALAB PRIVATE LTD | METHYLPREDNISOLONE USP (PROCESS 2) | 23 DMFs |
WAVELENGTH ENTERPRISES LTD | SUGAMMADEX SODIUM | Many DMFs |
TORRENT PHARMACEUTICALS LTD | FEBUXOSTAT | 28 DMFs. Torrent is one among many. More than half dozen ANDA filers. Torrent might file ANDA soon? |
DISHMAN CARBOGEN AMCIS LTD | CETRIMIDE | Very old molecule! An antiseptic and disinfectant first aid medicine used for cleaning wounds and treating minor burns. Only 2 other DMFs. Very cheap product, exported around USD 8-10/Kg |
General information
China still India’s largest source of import for many critical sectors, says top govt official
China is still India’s largest source of import for critical sectors like pharmaceuticals and electronics, Sanjay Chadha, Additional Secretary, Department of Commerce.
He also added that India’s production lines still suffer under Chinese control. “If China would stop API (active pharmaceutical ingredient) for penicillin, we would not be able to produce it in this country (India),” he said, and asked why India’s pharmaceuticals “do not find a place in Chinese shelves”. (Read more)
Sai Life Sciences Expands Capabilities
Sai Life Sciences, a contract research, development, and manufacturing organization (CRDMO), has unveiled plans to double its headcount and expand its suite of technical capabilities at its Manchester, UK site, a center of excellence for active pharmaceutical ingredient (API) process and analytical development serving an expanding list of global clients. (Read more)
Intellectual Property
H Lundbeck A/S vs Hetero Drug Ltd. on 23 December, 2020
The Delhi High Court passed an order on 23/12/2020 in the matter of H Lundbeck A/S v. Hetero Drugs Ltd., whereby it ruled that “export of the products from India would amount to use of the product in India” under Section 107 of the Act.
Lundbeck alleged infringement of their patent IN 227963 by Hetero and one more company. Lundbeck could prove to the court that that infringers manufactured and exported generic version of Vortioxetine to Latin America and Canada. The said patent was granted to Lundbeck in January 2009 titled as "Pharmaceutical Composition Comprising Phenyl Piperazine Derivatives (Vortioxetine) as Serotonin Reuptake Inhibitors".
An ad-interim injunction is granted in favour of Lundbeck and Hetero would not be able to export Vortioxetine till the next date of hearing before the Court. The Court order is 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.
