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Authorized Generics Frequently Asked Questions

What are authorized generics?
What is an innovator pharmaceutical company?
What is the difference between authorized generics and ANDA generics?
What are the similarities between authorized generics and ANDA generics?
What is the customer advantage of authorized generics?
What is the advantage of authorized generics to trade customers?


What are authorized generics?
The term Authorized Generics refers to pharmaceutical products that are produced by innovator (brand) companies under a New Drug Application (NDA), and marketed and distributed by, an authorized generic distributor like Patriot Pharmaceuticals with a generic product label.

Authorized Generics compete with ANDA generic products in the generic pharmaceutical channels of distribution.
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What is an innovator pharmaceutical company?
An innovator pharmaceutical company is an organization whose purpose is to improve the quality of human life by investing significant dollars, time, and resources in developing, testing (pre-clinical and clinical), and creating advancements in medicine.  Patriot partners with an innovator pharmaceutical company once their innovative products lose regulatory and patent exclusivity.
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What is the difference between authorized generics and ANDA generics?
An Authorized Generic is the innovator's prescription drug, approved under a New Drug Application (NDA) by the FDA, marketed and distributed by an authorized generic distributor like Patriot with a generic product label.

ANDA generics are produced and marketed under an Abbreviated New Drug Application, which relies on the innovator's safety and efficacy data in the NDA to obtain aproval to market a generic version of the innovator product.
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What are the similarities between authorized generics and ANDA generics?
Both are approved by the FDA to be sold and distributed through the same trade channels.
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What is the customer advantage of authorized generics?
Consumers will have the same product experiences with Authorized Generics as they did with the innovator pharmaceutical products in areas such as taste, color, mouth feel, size and shape.   This is because an authorized generic is the innovator's prescription drug approved under an NDA by the FDA, with a generic label.
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What is the advantage of authorized generics to trade customers?
The Trade can expect the same product quality and supply chain reliability it experienced with the innovator's branded product.  Multiple years of manufacturing experience, steady availability of raw materials, and ample production capacity that are available for Authorized Generics help to ensure supply reliability to trade customers.   An Authorized Generic competes directly with ANDA generic products and provides another competitive supply choice. More sources of supply generally reduce the cost of non-branded pharmaceuticals.

Additionally, store level patient counseling may be streamlined due to the fact that Authorized Generic pharmaceutical products have the same taste, color, mouth feel, size and shape as the innovator product.
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