Montelukast Intermediate Market

A patent is an exclusive sale right granted for an invention, product, or process that provides a new technical solution to a problem. In terms of the pharmaceutical market, the patent is being excised by various manufacturers to safeguard their products’ (drugs, APIs) sales. The European Patent Convention (EPC) requires all jurisdictions to give the European patent a term of 20 years from the actual date of applying. Likewise, in the US, the term of the patent is 20 years from the earliest filing date of the application on which the patent was granted. During this patent tenure, no other company (rather than the novel manufacturer) is allowed to market or manufacture the product, until there is a consent between two parties. Thus, the patent allows manufacturers to provide exclusive sales of their products in the absence of any competition for a limited period. Conclusively, the patent is seen as a reward for extensive research and development and capital invested by a company in creating a novel product

Molecule

Patent Number

Assignee/ Inventor

Title

Approval

Patent Expiry Date

Montelukast Intermediate

US7601741B2

· Synthon BV

Process for making montelukast and intermediates

20-11-2006

29-11-2026

Montelukast Intermediate

US20120165535A1

· Shandong New Time Pharmaceutical Co Ltd

A synthetic method for montelukast sodium intermediate

24-08-2010

31-10-2030

Montelukast Intermediate

WO2012020271A1

· József BÓDIJános FARAGÓKatalin SZÖKEViktor

· UJVÁRIKrisztina

· TEMESVÁRIAntal

· AranyiZsuzsanna SÁNTA

· Melinda Magdolna Nagy

Process for the preparation of montelukast sodium

08-10-2011

-

Montelukast Intermediate

WO2012123506A1

· Pere Dalmases BarjoanLidia Ozores Viturro

Montelukast intermediate camphorsulfonic salt

14-03-2011

Montelukast Intermediate

WO2014001860A1

· Srinivas Simhadri

· Yaseen MOHAMMADVenkata

· Sunil Kumar IndukuriSeeta Ramanjaneyulu GorantlaSatyanarayana Chava

Process for preparation of montelukast sodium

Abstract

17-05-2015

Source: MRFR Analysis

The montelukast intermediate market is entitled to witness rampant market growth during the forecast period from 2018 to 2023. Factors characterizing the market growth are worldwide rising prevalence of asthma, bronchospasm, allergic rhinitis, and urticaria, burgeoning pharmaceutical industry coupled with the increasing demand from API manufacturers, and montelukast patent expiration along with the increasing presence of generics. On the contrary, the presence of stringent regulatory policies and the high cost of manufacturing building blocks for active pharmaceutical ingredients (APIs) are likely to hinder market growth during the forecast period.

Research and development activities in montelukast intermediates by various organizations are expected to create ample opportunities for new market entrants and existing market players during the forecast period. Nanjing Wisdompharm Co., Ltd, a Chinese company focuses on technology innovations (in montelukast intermediates, pesticide formulation, and other chemicals), optimized management, and robust service system for its customers. In November 2018, IntelGenx Corp. (a Canadian oral drug delivery company engaged in the development and manufacturing of innovative pharmaceutical oral films based on its proprietary VersaFilm technology platform) commenced patient dosing in the Phase 2a study of montelukast VersaFilm in patients with mild to moderate Alzheimer’s disease (AD). This study enrolled around 70 subjects with mild to moderate Alzheimer’s disease to evaluate the safety, feasibility, tolerability, and efficacy of montelukast buccal film following the daily dosing for 26 weeks. Thus, these ongoing research activities in montelukast intermediates are expected to create promising avenues in the near future.

Stringent regulatory policies are imposed by various international healthcare authorities for the approval and use of pharmaceutical products. These authorities include US FDA (US), Medicines and Healthcare products Regulatory Agency (MHRA) (UK), Therapeutic Goods Administration (TGA) (Australia), Central Drugs Standard Control Organization (CDSCO) (India), Health Canada (Canada), Medicines Control Council (MCC) (South Africa), National Sanitary Surveillance Agency (ANVISA) (Brazil), European Medicines Agency (EMA) (European Union), State Food and Drug Administration (SFDA) (China), National Agency for Food and Drug Administration and Control (NAFDAC) (Nigeria), Medicines and Medical Devices Safety Authority (Medsafe) (New Zealand), Ministry of Health, Labor, and Welfare (MHLW) (Japan), Medicines Control Authority of Zimbabwe (MCAZ) (Zimbabwe), Swiss Agency for Therapeutic Products (Swissmedic) (Switzerland), Korea Food and Drug Administration (KFDA) (Korea), and Ministry of Health, Nutrition, and Indigenous Medicine (MoH) (Sri Lanka). These regulatory bodies ensure compliances in various legal and regulatory aspects of drugs. Government regulations lengthen the process for bringing new pharmaceuticals to the market thereby consuming time, which is anticipated to limit market growth over the forecast period.