"What" Series

What is the difference between a generic drug and an innovator drug?

8 December 2023
2 min read

Generic drugs are medications that have been approved by the FDA as equivalent to brand-name drugs in terms of safety, efficacy, and quality. They are typically manufactured after the patent term for the innovator drug has expired or been challenged successfully.
In contrast, innovator drugs are new chemical entities (NCEs) that have not previously been approved by the FDA. These drugs often undergo extensive testing and research before being submitted for approval, and may receive a period of market exclusivity once they are approved. The exact length of this period varies depending on the type of drug and the specific circumstances of its development.
Regarding patent protection, the duration of exclusive rights granted to the innovator depends on various factors such as the type of drug, the extent of clinical trials conducted, and the submission process. For example, a small molecule with a well-characterized target may be eligible for 10 years of protection from the date of first approval. However, some biologic drugs can have longer periods of protection due to their complexity and the challenges involved in their development and production.

What are HSP90 inhibitors and how do you quickly get the latest development progress?
What are HSP90 inhibitors and how do you quickly get the latest development progress?
8 December 2023
Hsp90 inhibitors are substances that inhibit the activity of the Hsp90 heat shock protein. They have therapeutic benefit in treating various types of malignancies, as Hsp90 stabilizes a variety of proteins required for cancer cell survival.
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How many types of NDA Classification Codes are there?
Knowledge Base
2 min read
How many types of NDA Classification Codes are there?
8 December 2023
There are 11 NDA Classification Codes.
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What is CBER's role after a biological product is approved and in use?
"What" Series
2 min read
What is CBER's role after a biological product is approved and in use?
8 December 2023
CBER continues to monitor the safety and stability of biological products that have been approved.
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Escient Pharmaceuticals Begins First Human Study of EP262, an Oral MRGPRX2 Inhibitor for Eczema Treatment
Latest Hotspot
3 min read
Escient Pharmaceuticals Begins First Human Study of EP262, an Oral MRGPRX2 Inhibitor for Eczema Treatment
8 December 2023
Escient Pharmaceuticals Commences First Human Study for EP262, a Novel Oral Drug Blocking MRGPRX2, Aimed at Treating Eczema.
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