How to sort out expired patented drugs on the FDA

You can check it on drugfuture**, **can't be transmitted, the curve saves the country ......The FDA Drug Patent Database uses the patent number as the keyword: the patent expire date: -Scope:

Compound patent product patent use patent Note: 1. If the patent number is used as the keyword, the patent number is not added to us and category**.

2. If the patent expiration period is the keyword, the determined time period will be directly selected.

Note: This database includes all valid drug patents recognized and published by the US FDA.

Typically, generic drugs, also known as generic drugs, must expire before they can be marketed. The search of drug patents is of great significance to the R&D and market of generic drugs. A search of this database will give you the following information:

1) By searching by patent number, you can query the patented drug information related to the patent. (2) With patent expiration inquiry, you can query the U.S. patents and corresponding drug information that have expired and expired in any period of time. (3) The full text of the patent in pdf tif format can be directly packaged through the U.S. patent function of the drug.

The FDA is the U.S. Food and Drug Administration, and does not accept or approve patents, and has nothing to do with patents. Do you mean with a joke that there are restrictions on the production and sale of drugs patented in the United States? That's what it means.

If a product has not applied for a patent in China and has been authorized, or has applied for an international patent and has not been formulated to enter China or to be authorized in China, then we can all imitate it. However, now the international enterprises are very strong in patent awareness, especially for developing countries like us, usually they will apply for patents in our country, so there are almost no loopholes mentioned above.

Regardless of whether it is a drug or not, as long as it is a patent, it has exclusive rights, and US patents are no exception.

Pharmaceutical patents can only be invention patents, and according to China's Patent Law, the protection period of invention patents is 20 years.

First of all, let's be clear about the concept, new drugs and patents are not the same concept. According to the Measures for the Administration of Drug Registration, a new drug refers to a drug that has not been marketed in China.

A drug patent is a patent for the formulation or preparation process of a drug.

Patented drugs do not necessarily conform to the concept of new drugs, because the same drug can be patented differently because of different preparation methods.

Article 2 The term "invention-creation" as used in this Law refers to inventions, utility models and designs.

An invention refers to a new technical solution proposed for a product, a process or an improvement thereof.

Utility model refers to a new technical solution suitable for practical use proposed for the shape, structure or combination thereof of a product.

Design refers to a new design that is aesthetically pleasing and suitable for industrial application made of the shape, pattern or combination thereof, as well as the combination of color and shape and pattern.

Rule 42 The term of a patent right for invention shall be 20 years, and the term of a patent right for utility model and a patent right for design shall be 10 years, both of which shall be calculated from the date of application.

You are here:Home The term of protection of new drug patents, there are no special provisions in China, that is, 20 years for invention patents and 10 years for utility models and designs. In the United States, Japan and other countries, the term of patent protection is also 20 years, but the United States and Japan have implemented a patent compensation term system. The United States was the first country to implement a patent compensation term system.

In 1984, the U.S. Congress enacted the Drug Competition and Patent Term Compensation Act, Article II of which provides that patentees of inventions of human drugs, medical devices, food additives and color additives may compensate for part of the lost patent protection time due to the patent product pending federal pre-marketing approval. The extension period in the United States is equal to 1 2 (clinical trial phase time) plus the time of the application phase, and the extension period is generally not more than 5 years.

However, since FDA approval, the actual term of protection cannot exceed 14 years. The compensation period for a patent in Japan shall be calculated from the date of patent registration and the date of commencement of clinical trials, and shall end on the date of obtaining the administrative license, and the total compensation period shall not exceed 5 years. The application must be submitted within three months after receiving the above-mentioned administrative license, but the above-mentioned application shall not be submitted after the expiration of the original patent protection period.

Patent term compensation applies to human or veterinary drugs, human or veterinary diagnostic reagents or materials, medical use, and does not apply to medical devices or devices. It is hoped that China will also establish a compensation system for the protection period of patented drugs as soon as possible to promote drug research and development into a virtuous circle. Pharmaceutical patent application.

U.S. FDA refers to the U.S. Food and Drug Administration, which is official**.

Because the U.S. FDA has a large number of public data on Serino, including the compliance status of some foods, drugs, medical devices, radiation electronics, cosmetics, tobacco products (including e-cigarettes), compliance guidelines, databases, pages about consumers, discussions within the industry, Q&A, hyperlinks, etc. Because the U.S. FDA is a large organization, the products it manages are relatively complex and the security requirements are extremely high, so the amount of information that needs to be stored is very large.

If you want to know more about FDA, we recommend consulting FDA Registrar Corp Technical Services****. Founded in 2003, Registrar Corp assists companies around the world in complying with U.S. Food and Drug Administration (FDA) regulations. The head office is located in Virginia, USA, and has 19 representative offices around the world.

The team includes former U.S. FDA**, lawyers, scientists, and senior experts in the industry's first shed. It has a dedicated U.S. team that has assisted more than 50,000 companies in more than 160 countries to safely export to the U.S.