Enzolytics Inc (ENZC)

[bigtalan]

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. Some drugs have both patent and exclusivity protection while others have just one or neither 1. Therefore, a drug does not need to be approved to protect a patent. However, if a drug is approved, it can get exclusivity protection which can indirectly extend market exclusivity of a product 2.

Learn more:

1. fda.gov
2. ajmc.com
3. bing.com
4. sidley.com
5. finnegan.com

Patents protect a drug manufacturer’s invention (for example, a new drug or a new use for a drug) and prevent other manufacturers from marketing products covered by the patent, among other things. Generally, a patent term is 20 years from the date of filing with the PTO1. FDA does not enforce patents, or evaluate patent validity or infringement. Rather, new drug application (NDA) holders for a “brand-name” drug product submit patent information to FDA for inclusion in FDA’s “Orange Book”1. The Orange Book lists patents that have been submitted to the FDA by drug companies2. The exclusivity period is different from the patent term and is granted by the FDA. It is intended to encourage innovation by providing a period of market exclusivity to the first applicant to gain approval of a particular drug2.

Learn more:

1. fda.gov
2. fda.gov
3. bing.com
4. aurorapatents.com
5. alacrita.com
6. crsreports