Can medication be patented?

Patents and exclusivity apply to drugs in different ways. Patents can be issued or expire at any time regardless of the drug’s approval status. Exclusivity attaches upon approval of a drug product if the statutory requirements are met.

Is drug license required for OTC products?

Non-prescription drugs specified in Schedule K can also be sold in non-pharmacies as there is no license requirement to sell them. Therefore, OTC drugs can be sold through additional locations than other drugs.

What makes a drug patentable?

What is patentable? A patentable invention must be novel, useful, and non-obvious. An invention is defined as a new and inventive solution to a technical problem. Ideas, laws of nature, scientific principles, ‘immoral’ inventions, and human life or its parts aren’t patentable.

When can you patent a drug?

Pharma companies file for a patent soon after the discovery of a drug and its novel mechanism of action. From that point the company has a 20-year patent for the product, but R&D can take up to 15 years, so by the time the products is approved and available on the market, the patent can be close to running out.

Do OTC drugs need FDA approval?

Nonprescription drug products conforming to an OTC monograph and other relevant general requirements are generally recognized as safe and effective and are not required to be individually reviewed and approved by the FDA before U.S. marketing.

Who regulates OTC drugs?

The Food and Drug Administration (FDA) has regulated most over-the-counter (OTC) drugs—that is, drugs available without a prescription—through the OTC monograph process.

How do I find out if a drug is patented?

The information is collected from various publicly available and accessible databases including USFDA, EMEA, DCGI, USPTO, Espacenet, WIPO-Patentscope etc and details for applications filed in India is compiled from the Indian Patent Office website (IPAIRS http://ipindiaservices.gov.in/patentsearch/search/index.aspx ).

Can generic drugs be patented?

A generic drug is a pharmaceutical drug that contains the same chemical substance as a drug that was originally protected by chemical patents. Generic drugs are allowed for sale after the patents on the original drugs expire.