24 big-selling drugs to lose patents in US, big opportunity for Indian drugmakers

New Delhi: A total of 24 blockbuster drugs, with global sales worth $251 billion, have lost or will lose their patents in the United States by 2030, potentially unlocking huge business and growth opportunities for Indian pharmaceutical companies, according to a report by the Department of Pharmaceuticals (DoP).

According to the report, India’s pharmaceutical sector is bound to see massive potential for generic drug entry during 2022-2030. Mega-selling anti-rheumatic drug Humiras’ patent has already expired, while anti-cancer drugs Keytruda, Opdivo, Revlimid and Avastin and diabetes and obesity drugs Victoza, Januvia and Trulicity, among others, are up of the patent expiring.

Some other top-selling drugs on the list include Stelara, a drug for a chronic digestive condition called Crohn’s disease, and OxyContin, a pain reliever.

The expiration of the patents would mean that drugmakers will be able to release generic versions of these drugs, which are often priced up to 90 percent lower than their breakthrough drug. This will allow health care providers and insurers to realize substantial cost savings, the report suggests.

The report, accessed by ThePrint, was prepared for the government by Biovantis Healthcare, a health data science and compliance company. He adds that the impending loss of patents will affect most of the big biopharma players in the U.S. and Europe, but some, such as Pfizer, Novartis, Merck, Eli Lilly and Bristol Myers Squibb, are poised to face more patent cliffs pronounced or loss of income. add.

Through the exercise, which lasted for about six months, our aim was to identify the growth of business potential in the US and other global markets, said a senior DoP official.

The Indian generic pharmaceutical market has witnessed remarkable growth over the years underlines the report. According to DoPs Annual Report 2022-23, the total annual turnover of pharmaceuticals during FY 2021-22 in India was approximately $42.34 billion.

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Need for a switch to biosimilars

Drugs can be roughly divided into two categories based on their technical characteristics, pharmaceutical or small-molecule drugs, and biological or large-molecule drugs, such as vaccines, monoclonal antibodies, and immune modulators derived from biological sources.

Small-molecule drugs tend to be simpler to make and cheaper for the buyer, but the report notes that while Indian drugmakers have much more experience making generic versions of these drugs, the drugs that are sold off patent are mostly biological. This implies that it may be challenging for Indian drug manufacturers to produce their biosimilars (generic versions of biological drugs).

Indian generic companies have extensive experience in reverse engineering chemical drugs to develop generic versions and transfer the technology for mass production. However, for biosimilar, technology development and transfer are challenges. In addition, the types of patents used for biologics and small-molecule drugs and the strategies for using (or attacking) those patents are also very different from biosimilars, he says.

The report also notes that the regulatory and commercial consideration for obtaining approval for new or late stage biologics and small molecule drugs is vastly different, making biosimilars a riskier and more complex proposition for Indian generic companies.

So far, only a few Indian companies have ventured into this space and developed initial capabilities, but others need to rapidly expand their capabilities.

The global generic drugs market was valued at approximately $228 billion in 2020 and is expected to reach a value of $380 billion by 2030, growing at a compound annual growth rate (CAGR) of about 6, 2 percent over the forecast period.

The global generic pharmaceutical market is highly competitive and several major players operate on a global scale. These companies have established themselves as leaders in the generic drug industry, supplying a wide range of affordable drugs worldwide, the report added. list of the top 15 generic suppliers worldwide.

It then lists the top 15 generic suppliers globally, which includes seven Indian companies Sun Pharma, Dr Reddys Laboratories, Lupin, Cipla, Aurobindo Pharma, Zydus Cadila and Torrent Pharma.

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India’s Pharmaceutical Space: Is Quality an Issue?

The report sees India’s generic pharmaceutical industry as one of the largest and fastest growing sectors in the country, adding that India has more than 600 manufacturing sites approved by the US Food and Drug Administration (USFDA), which constitute nearly 12.5 percent of all registered manufacturing. facilities operating outside the US.

In addition, there are 500 API (active pharmaceutical ingredient) manufacturers, which contribute 8 percent. in the global API industry. Additionally, India is the largest supplier of generic drugs with a 20% share of global supply, manufacturing 60,000 different generic brands across 60 therapeutic categories.

The country exports about 30 percent of its total pharmaceutical exports to the US, the report says, but it also lists quality issues as a key weakness of the Indian pharmaceutical sector.

The report highlights that while India has many reputable drug manufacturers, the industry has also faced quality and compliance concerns.

Maintaining consistent quality and compliance with Good Manufacturing Practices (GMP) is crucial to the reputation and success of pharmaceutical companies, he stressed, adding that non-compliance and quality issues it can lead to regulatory action, import bans and damage to the industry’s image.

The Indian pharmaceutical market has been facing challenges with counterfeit and substandard drugs. These products not only pose risks to patient safety, but also damage the reputation of the industry. The report says there is a need to strengthen regulatory oversight and implement robust supply chain controls to address this issue.

He noted that recent cases of non-compliance with quality standards and regulations have put India under the scanner of regulatory authorities.

(Edited by Mannat Chugh)

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