Definition
Authorized Generic (AG) is a version of a brand-name drug marketed as a generic by or with permission from the brand company. It’s typically identical to the brand product and can be launched without an ANDA, even during 180-day exclusivity periods.
How Authorized Generics Work
Brand companies can launch authorized generics under their existing NDA or license the right to a generic partner. No separate FDA approval is required since the product is already approved.
Authorized Generic Launch Options
| Approach | Description |
|---|---|
| Brand Subsidiary | Brand’s own generic division markets AG |
| Licensing Partner | Brand licenses AG rights to generic company |
| Settlement Agreement | AG rights as part of Paragraph IV settlement |
Strategic Uses of Authorized Generics
- Compete During 180-Day Exclusivity: Enter market alongside first filer
- Reduce Settlement Costs: Threaten AG launch in Paragraph IV negotiations
- Capture Generic Revenue: Maintain share as market goes generic
- Delay Profit Loss: Slow erosion of franchise value
Why BD Teams Track Authorized Generics
For business development professionals, AG strategy affects market dynamics:
- Deal Implication: AG provisions are common in Paragraph IV settlements
- Due Diligence Focus: Assess AG strategy for products approaching generic entry
- Opportunity Signal: Companies seek AG partners for manufacturing and distribution