Patents and Exclusivity Approach for Monopoly
Did you know that “patent” and “exclusivity” are two of the most commonly searched terms on the FDA website?
Generics account for more than 80% of prescription drugs in the US, and that number continues to grow. With approaching patent expirations of several top-selling prescription brand-name drugs, sponsors of innovator drug products and generic manufacturers need to know the ins and outs of patents and exclusivity.
Let's find out the basics difference between patents & exclusivity.
Patents:
A patent is a property right issued by the respective patent office to an inventor “to exclude others from making, using, offering for sale, or selling the invention throughout the respective territory or importing the invention into the respective territory” for a limited time, in exchange for public disclosure of the invention when the patent is granted.
Generally, the term of a new patent is 20 years from the date on which the application for the patent was filed in any country. A company may apply for a patent from the respective patent office anywhere along the development lifeline of a drug and can encompass a wide range of claims. However, many other factors can affect the duration of a patent.
Exclusivity:
Exclusivity is exclusive marketing rights granted upon approval of a drug and can run concurrently with a patent or not. It prevents the submission or effective approval of ANDAs or applications described in Section 505(b)(2) of the Act, and was designed to promote a balance between new drug innovation and generic drug competition. Exclusivity is granted upon approval of a drug product if the statutory requirements are met.
The length of time that FDA grants new drug exclusivity depends on the type of exclusivity.
There are four types of exclusivity (FDA) that fall under the NDA statutory requirements:
1. Orphan Drug Exclusivity (ODE) - 7 years
2. New Chemical Exclusivity (NCE) - 5 years
3. "Other" Exclusivity - 3 years for a "change" if criteria are met.
4. Pediatric Exclusivity (PED) - 6 months added to existing Patents/Exclusivity.
5. 180-Day Exclusivity: FDA may also grant exclusivity to abbreviated new drug applications (ANDAs) for generic drugs. Under the Drug Price Competition and Patent Term Restoration Act, or the Hatch-Waxman Act, a company can seek approval from FDA to market a generic drug before the expiration of a patent relating to the brand name drug upon which the generic is based. The first company to submit an ANDA with the FDA has the exclusive right to market the generic drug for 180 days. This is called 180-day exclusivity.
Generics account for more than 80% of prescription drugs in the US, and that number continues to grow. With approaching patent expirations of several top-selling prescription brand-name drugs, sponsors of innovator drug products and generic manufacturers need to know the ins and outs of patents and exclusivity.
Let's find out the basics difference between patents & exclusivity.
Patents:
A patent is a property right issued by the respective patent office to an inventor “to exclude others from making, using, offering for sale, or selling the invention throughout the respective territory or importing the invention into the respective territory” for a limited time, in exchange for public disclosure of the invention when the patent is granted.
Generally, the term of a new patent is 20 years from the date on which the application for the patent was filed in any country. A company may apply for a patent from the respective patent office anywhere along the development lifeline of a drug and can encompass a wide range of claims. However, many other factors can affect the duration of a patent.
Exclusivity:
Exclusivity is exclusive marketing rights granted upon approval of a drug and can run concurrently with a patent or not. It prevents the submission or effective approval of ANDAs or applications described in Section 505(b)(2) of the Act, and was designed to promote a balance between new drug innovation and generic drug competition. Exclusivity is granted upon approval of a drug product if the statutory requirements are met.
The length of time that FDA grants new drug exclusivity depends on the type of exclusivity.
There are four types of exclusivity (FDA) that fall under the NDA statutory requirements:
1. Orphan Drug Exclusivity (ODE) - 7 years
2. New Chemical Exclusivity (NCE) - 5 years
3. "Other" Exclusivity - 3 years for a "change" if criteria are met.
4. Pediatric Exclusivity (PED) - 6 months added to existing Patents/Exclusivity.
5. 180-Day Exclusivity: FDA may also grant exclusivity to abbreviated new drug applications (ANDAs) for generic drugs. Under the Drug Price Competition and Patent Term Restoration Act, or the Hatch-Waxman Act, a company can seek approval from FDA to market a generic drug before the expiration of a patent relating to the brand name drug upon which the generic is based. The first company to submit an ANDA with the FDA has the exclusive right to market the generic drug for 180 days. This is called 180-day exclusivity.
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