Insight health with new patent information blockbuster interferon beta 1a loses patent protection ge

Overview / INSIGHT Health GmbH& Co. KG / Announcement from 20.07.2021Tuesday, 20. July 2021, 10:11 a.m

INSIGHT Health GmbH& Co. KG

INSIGHT Health press release

INSIGHT Health with new patent information: Blockbuster interferon beta-1a loses patent protection

Waldems-Esch – In the last quarter of this year, the patent of interferon beta-1a, the top product in the multiple sclerosis market, expires. In addition, from July to September 2021, seven pharmaceutical substances will lose. Combinations of substances their patent protection. This can be seen in the patent database SHARK of INSIGHT Health.

The blockbuster in 2021 is interferon beta-1a, the patent for which is due to expire in 26. October runs off. Although a supplementary protection certificate has been approved in numerous EU countries, it has been rejected in Germany. The drug is produced by genetic engineering. Finds use in the therapy of relapsing-remitting multiple sclerosis (MS). In the MS market (ATC3 class N07A), interferon beta-1a is the top product by sales with a market volume of 232.5 million euros. This corresponds to a market share of just under 16 percent (based on the pharmaceutical company's sales price; SHI billing data, INSIGHT Health).

Furthermore, the patents of seven pharmaceutical substances and substance combinations expire from July to September 2021. Among them is the genetically engineered drug Abatacept, which will lose patent protection in July for the treatment of rheumatic diseases. The immunosuppressive and anti-inflammatory agent is mainly used for the treatment of rheumatoid arthritis and has a sales share of around 14 percent in the market for anti-rheumatic drugs (according to the pharmaceutical company's sales price; GKV billing data, INSIGHT Health). The protection by a supplementary protection certificate of the basic substance has already expired at the end of 2017.

It is also worth noting that in the last three months, an application for pediatric extension of patent protection was filed or an extension was granted for 25 drugs. Slightly more than a quarter of all applications were for antidiabetics (ATC2 class A10). Four for antiviral substances for systemic use (ATC2 class J05). At the same time, the supplementary protection certificate for four substances was extended by six months in Germany. The extension is based on a pediatric investigation plan (PIP) and the pediatric approval in all EU countries. The investigational plan outlines the development program for the use of the drug in children.

Expansion of the portfolio on patent information

In addition to the online version of the SHARK database, INSIGHT Health now offers another service in the area of patent information with the Patent Expirations Report. This provides a concise overview of the current patent situation in numerous countries worldwide. Thus forms an informed basis for decisions in the drug marketplace. "The decisive advantage is that not only the actual situation of patent expiries is provided, but also an evaluation of the possible entry of generics and biosimilars takes place. In addition, special exclusivities such as an orphan drug status, extensions through supplementary protection certificates as well as legal ambiguities are shown.", says Esther Zollner, Director Patent Insights at INSIGHT Health.

INSIGHT Health is one of the leading information service providers in the healthcare market, headquartered in Waldems-Esch with offices in Berlin and Vienna. The company offers a broad portfolio of data-based services for market and healthcare research based on its extensive industry expertise. The plus of INSIGHT Health GmbH& Co. KG lies in the rapid and transparent provision of data in compliance with statutory data protection regulations and in the development of individual solutions for the pharmaceutical industry, health insurance companies, doctors' associations, pharmacy associations, scientific institutes, authorities, politicians and other decision-makers in the healthcare market.

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