Authorized Generics Frequently Asked Questions



What are Authorized Generics?

Authorized Generics are pharmaceutical prescription products that are manufactured by the innovator (brand) company under the New Drug Application, but do not have the brand name on the label and are sold like a generic product. 

For reference, see FDA definition and current list of Authorized Generics:
https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/fda-list-authorized-generic-drugs

What is an innovator pharmaceutical company?

An innovator pharmaceutical company is the new drug application (NDA) holder.  The innovator is the first company to develop the drug, complete the required testing (pre-clinical and clinical), seek FDA approval, and bring the drug to market for patients to use.  Patriot partners with innovator pharmaceutical companies like Janssen Pharmaceuticals, Inc. to make authorized generic products available to patients.

What is the difference between Authorized Generics and ANDA generics?

An Authorized Generic is the innovator’s prescription drug–previously approved under a New Drug Application (NDA) by the FDA – marketed and distributed by an authorized generic distributor like Patriot Pharmaceuticals.

An Authorized Generic is identical to the brand name product with potentially a few minor differences such as color, product markings, packaging, or labeling.  Both the Authorized Generic and the brand name drug are manufactured under the same NDA and share the following qualities:

  • Active ingredients
  • Strength
  • Dose
  • Dosage form
  • Route of administration
  • Intended use
  • Inactive ingredients
  • Taste, smell, mouthfeel
  • Size
  • Shape

ANDA generics are copies of the innovator’s prescription drug, approved under an Abbreviated New Drug Application (ANDA).  Per the FDA, a generic drug product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics, and intended use.

https://www.fda.gov/drugs/types-applications/abbreviated-new-drug-application-anda

What are some advantages of an Authorized Generic?
Patients will have the same product experiences with Authorized Generics as they did with the brand name products in areas such as taste, color, mouth feel, size and shape. 
Trade customers can expect the same product quality and supply chain reliability they experienced with the brand name products, but at a lower acquisition price.  Multiple years of manufacturing experience and production capacity are available for the Patriot line of authorized generics.


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