DrugPatentWatch Frequently Asked Questions

1.What is the difference between patents and exclusivity?

Patents and exclusivity work in a similar fashion but are distinctly different from one another. Patents are granted by the patent and trademark office anywhere along the development lifeline of a drug and can encompass a wide range of claims. Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statuatory provision and is granted to an NDA applicant if statuatory requirements are met. See 21 C.F.R. 314.108.  Exclusivity was designed to promote a balance between new drug innovation and generic drug competition.

2.How long is a patent granted for?

Patents expire 20 years from the date of filing.  Many other factors can affect the duration of a patent.

3.How long is exclusivity granted for?

It depends on what type of exclusivity is granted.
Orphan Drug (ODE) - 7 years
New Chemical (NCE)- 5 years
"Other" Exclusivity - 3 years for a "change" if criteria are met
Pediatric Exclusivity (PED) - 6 months added to existing Patents/Exclusivity
Patent Challenge – (PC) – 180 days (this exclusivity is for ANDAs only)

See 21 C.F.R. 314.108 New Drug Product Exclusivity.

4. Why does the exclusivity expire before the patent?
Patent before exclusivity?
Why does a particular drug product only have patents?
Only have exclusivity?
Have neither?

Patents can be expired before drug approval, issued after drug approval, and anywhere in between. Exclusivity is granted upon approval of a drug product if the statuatory requirements are met. Some drugs have both patent and exclusivity protection while others have just one or none. Patents and exclusivity may or may not run concurrently and may or may not encompass the same claims. Exclusivity is not added to the patent life. Expired patents and exclusivity are not included in the published list.

5. Why don’t I see some antibiotic drugs products listed in the Patent and Exclusivity section?

Title I of the 1984 Amendments did not apply to drug products submitted or approved under the former Section 507 of the Federal Food, Drug, and Cosmetic Act (antibiotic products). Therefore,
(1) holders of approved applications for antibiotic products did not need to submit the patent information required of other NDA application holders,
(2) these antibiotic products were not eligible for exclusivity protection, and
(3) applicants submitting abbreviated applications for these antibiotic products were not required to provide the patent certification statement that was included in ANDAs.

Antibiotics submitted after the effective date of the Food and Drug Administration Modernization Act (FDAMA) are covered or subject to the provisions of Title I.  See Guidance for Industry and Reviewers Repeal of Section 507 of the Federal Food, Drug and Cosmetic Act for more information.

When pediatric exclusivity is granted to a drug product, a period of 6 months exclusivity is added to all existing patents and exclusivity on all applications held by the sponsor for that active moiety. The *PED designation indicates a pediatric extension.  Related information can be found on the Pediatric Medicine Page and Pediatric FAQ page.

7. Where can I find patent and exclusivity regulations in the C.F.R.?

C.F.R (Code of Federal Regulation). An external link to the Code of Federal Regulations on the Government Printing Office web site.