How long does it take for the FDA to approve a generic drug?

Some generic versions of priority drugs – drugs that CDER has determined to potentially provide a significant advance in medical care — have been approved in six months or less. Other times it may take years before FDA’s scientific and medical team is 100 percent confident in an approval decision.

How long does it take for a generic drug to be developed?

However, a generic drug can only be marketed after the brand name drug’s patent has expired, which may take up to 20 years after the patent holder’s drug is first filed with the U.S. Food and Drug Administration (FDA). Generic drugs are usually much less expensive than brand name drugs once they reach the market.

How does the FDA approve generic drugs?

Generic drugs are approved only after a rigorous review by FDA and after a set period of time that the brand product has been on the market exclusively. This is because new drugs, like other new products, are usually protected by patents that prohibit others from making and selling copies of the same drug.

How long does it take to develop a brand name drug?

When a new drug is discovered, the company that discovered it would apply for patency to prevent other companies from producing and selling the drug. This patency may take up to 20 years and during this period, the company will produce and sell the drug under a brand name to recover its investment and make a profit.

How does a biosimilar get approved?

The FDA approves a biosimilar after a manufacturer establishes that the product is highly similar to a previously approved originator biologic reference product without any clinically meaningful differences in safety, purity, and potency.

Do generic drugs work slower than branded drugs?

The FDA requires that generic drugs work as fast and as effectively as the original brand-name products. Sometimes, generic versions of a drug have different colors, flavors, or combinations of inactive ingredients than the original medications.