Biden administration unveils first 10 drugs subject to Medicare price negotiations

[BumRushDaShow]

42. "they are prohibited by the FDA to putting them on the market for a couple of years"

It's FDA following Patent law and statutes related to it in the FD&C Act - https://www.fda.gov/drugs/development-approval-process-drugs/frequently-asked-questions-patents-and-exclusivity#What_is_the_difference_between_patents_a

Summary of that from the FDA FAQ (from that link)-

Orange Book Frequently Asked Questions

1. What is the difference between patents and exclusivity?
Patents and exclusivity work in a similar fashion but are distinct from one another and governed by different statutes. Patents are a property right granted by the United States Patent and Trademark Office anytime during the development of a drug and can encompass a wide range of claims. Exclusivity refers to certain delays and prohibitions on approval of competitor drugs available under the statute that attach upon approval of a drug or of certain supplements. A new drug application (NDA) or abbreviated new drug application (ANDA) holder is eligible for exclusivity if statutory requirements are met. See 21 C.F.R. 314.108, 316.31, 316.34 and sections 505A, 505E, and 505(j)(5)(B)(iv) of the FD&C Act. Periods of exclusivity and patent terms may or may not run concurrently. Exclusivity was designed to promote a balance between new drug innovation and greater public access to drugs that result from generic drug competition.


2. How long is a patent term?
Patent terms are set by statute. Currently, the term of a new patent is 20 years from the date on which the application for the patent was filed in the United States. Many other factors can affect the duration of a patent.


3. How long does an exclusivity period last?
It depends on what type of exclusivity is at issue.

Orphan Drug Exclusivity (ODE) – 7 years

New Chemical Entity Exclusivity (NCE) – 5 years

Generating Antibiotic Incentives Now (GAIN) Exclusivity– 5 years added to certain exclusivities

New Clinical Investigation Exclusivity – 3 years

Pediatric Exclusivity (PED) – 6 months added to existing Patents/Exclusivity

Patent Challenge (PC) – 180 days (this exclusivity is for ANDAs only)

Competitive Generic Therapy (CGT) - 180 days (this exclusivity is for ANDAs only)

See 21 C.F.R. 314.108, 316.31, 316.34 and sections 505A, 505E, 505(j)(5)(B)(iv), and Section 505(j)(5)(B)(v) of the FD&C Act.

(snip)

More: https://www.fda.gov/drugs/development-approval-process-drugs/frequently-asked-questions-patents-and-exclusivity#What_is_the_difference_between_patents_a

On average it's about 17 years from when they decide to go with a patented entity, and then get it to the finished product stage, and on the market. The faster they can get it approved, the longer it can be sold without competition before the patent expires. What normally happens is once a company finds an active ingredient and decides to patent it, it often takes time to go through researching how to formulate it, then test dosage forms and amounts through animal and clinical trials, and finally get approval of their NDA (New Drug Application). If they run into problems getting a finished product on the market, that might mean that they do only have a few years left on the patent before someone else can use it.

What happens too is that the biggest pharma companies may have generic firms in their corporate portfolios so they often have those firms submit an ANDA (Abbreviated New Drug Application) for a lesser cost "generic" version of the original (but will still pocket the $$$ even though they are the innovator firm).