World Intellectual Property Day! 10 billion anti-cancer drugs are not selected in the "Encouraged Generic Drug Catalog", and there are no corporate generics for the 2 major varieties...

The World Intellectual Property Day (TheWorldIntellectualPropertyDay) was established by the World Intellectual Property Organization on April 26, 2001. Today (April 26) is the 21st World Intellectual Property Day. The purpose is to foster awareness of respecting knowledge, advocating science and protecting intellectual property rights worldwide, and create a legal environment that encourages knowledge innovation.

As a big country of generic drugs, China has a close relationship between intellectual property and medicine. At present, most of the drugs on the market in China are imitations of European and American original research drugs, and are listed after the patent protection of the original research drugs expires.

Due to China’s huge drug market demand, original research drugs and imported drugs are expensive, with a unit price of tens of thousands of yuan, but they are necessary for treatment and life-saving; generic drugs and original drugs have the same active ingredients, dosage forms, administration routes and The therapeutic effect is much cheaper, and it has become a new choice for patients to use drugs, while saving medical insurance funds. Therefore, the state encourages pharmaceutical companies to imitate drugs that are in short supply and insufficient competition.

The generic drug market is changing, 17 varieties encourage imitation

Recently, the National Health Commission and other six departments organized experts to select and demonstrate the selection and demonstration of domestic patents that have not yet submitted registration applications, clinical supply shortages and insufficient competition, and formulated the "Second Batch of Encouraging Generic Drugs Catalog" and released it. List. It covers 17 kinds of drugs, involving many indications such as primary biliary cirrhosis, epilepsy, and constipation, including sustained-release tablets, oral solutions, oral suspensions and other dosage forms. It is worth mentioning that the drugs included in the list of generic drugs are supported by relevant departments in clinical trials, research on key common technologies, and priority review and approval.In order to allow the industry to have a clear understanding of the patent expiration, application for registration and domestic listing of the drugs in the catalog, and to be targeted, the author has sorted out relevant information for the industry's reference.

2 varieties were unsuccessful, including the tens of billions of varieties Olapali

Compared with the 19 recommended generic drugs in the second batch of encouraged generic drugs list, brimonidine timolol and olaparib failed to be selected.

Olapali's first domestic PARP inhibitor, originally from AstraZeneca, was approved in China in 2018 and successfully renewed in 2020 medical insurance negotiations, and expanded medical insurance reimbursement indications to the front line of BRCA-mutated advanced ovarian cancer Maintenance treatment. According to Yaozhi's global best-selling drug database, olaparib sales reached 16.356 billion yuan in 2020, a year-on-year increase of 44.61%. According to Yaozhi Patent Communication, the expiration date of Olapali patent is March 12, 2024. At present, more than ten domestic enterprises including Luoxin, Hausen, CSPC, Kelun, and CP Tianqing have deployed and applied for imitation.

7 varieties of patents have expired, these varieties are competing for layout

It is worth noting that among the 17 drugs in the second batch of encouraged generic drugs list, clevidipine, milaberon, mamorelin, eslicarbazepine, tasmetron, tapentadol, cabazitaxel Seven varieties of domestic compound patents have expired, and three varieties of obeticholic acid, eligrostat and arformoterol have no domestic compound patents; the remaining 7 varieties of arformoterol have domestic compound patents in 2021- 2022 expires in the next two years, and the latest elagoli compound patent will expire in July 2024.

In addition, among the 17 varieties, clevidipine, milaberon, cabazitaxel, desvenlafaxine and other varieties have attracted more attention from generic drug companies, and more than 15 generic drug companies of each category applied for registration and competed Fierce, among them, clevidipine imitation application companies have the most, 25 companies have already applied; followed by cabazitaxel, 21 companies have applied for registration.

Clevidipine Butyrate is a third-generation new short-acting dihydropyridine calcium channel antagonist developed by AstraZeneca. The Medicines Company of the United States has its development and commercialization authorization in the global market except Japan. As a new type of antihypertensive drug for intravenous injection, this product represents a major progress in the current field of hypertension treatment, and promotes the rapid and precise control of blood pressure in critical care.

Cabazitaxel (Jevtana) was developed by Sanofi Pharmaceuticals and was approved by the US FDA for marketing. It is an anti-tumor drug, which is mainly used in combination with prednisone to treat patients with metastatic prostate cancer that has been refractory to hormones with docetaxel in the past. It is worth noting that cabazitaxel, apatamide, and enzalutamide have long dominated the Chinese prostate cancer market.



There are no corporate imitations for 2 heavy varieties

However, the varieties of tasmetron, pukanatide, and elagoli have not received enough attention from generic pharmaceutical companies. This directly reflects that there are few applications and registrations. There are no domestic companies for the two varieties of talsmetron and elagoli. Declare imitation.

Elagolix is an oral GnRH antagonist jointly developed by Abbvie and its partner Neurocrine Bioscienc Chemical bookes. It was approved by the FDA for listing in July 2018. It was the first oral new drug approved by the FDA for endometriosis in 10 years. Currently, the original drug has not yet been marketed in China. Its compound patent expires in July 2024, and there is no domestic drug. Enterprise registration and application for imitation. According to public data, the global sales of Orilissa and Relumina (Orilissa and Relumina, an oral small molecule GnRH receptor antagonist jointly developed by Japanese Takeda and Aska Pharmaceuticals, and MyovantScience) in 2019 are approximately US$122 million.

Tasimelteon is a melatonin MT1 and MT2 receptor agonist. It is the first drug approved by the FDA for the treatment of non-24-hour wakefulness disorder (N24HSWD). The drug was originally developed by Bristol-Myers Squibb and later developed by Vanda. It was approved by the U.S. FDA on January 31, 2014. It has not yet been marketed in China, and no domestic company has applied for imitation. The patent for the original compound has been issued in 2018. Expired in the year. According to Yaozhi's global best-selling drug data, in 2020, the global sales of talsmetron is 1.051 billion yuan, a year-on-year increase of 6.71%.

In terms of domestic approval for marketing, among the 17 varieties in the generic drug catalog, only fluticasone furoate, vilanterol, flutimavir, miraberone, perampanel, and brivaracetam, only have original research drugs. Approved for marketing, the remaining 12 varieties have not been approved for marketing of original research or generic drugs in China.

Experts said that the introduction of the catalogue of encouraged generic drugs by the state not only solves the dilemma of no drugs available in the country, but also eases the problem of expensive drugs; in addition, after enterprises understand the information, they can promptly develop timely and efficient research and development based on their own advantages to meet the needs of the market. Expanding its own product line while meeting the needs of patients. At the same time, encouraging generic drugs to replace original research drugs can greatly reduce the burden on medical insurance departments.

Data and data sources: Yaozhi Data, Yaozhi Patent Pass, corporate announcements and other public information and data.