In the ever-evolving landscape of pharmaceuticals, one of the more nuanced and strategic decisions a brand company can make is whether to launch an Authorized Generic (AGx) product. I’ve been fortunate to work closely with clients navigating this decision, and one thing has become abundantly clear: competitive intelligence is a critical enabler of success in this space.

For those unfamiliar, an authorized generic is essentially a brand-name drug marketed without its label, typically through a separate channel or partner, at generic pricing. It’s chemically identical to the brand but sold under a generic name. While the primary intent is often to defend market share during the onslaught of generic competition, the playbook around AGx is far more strategic—and highly dependent on timely, accurate competitive insight.

Making the Call: To Launch or Not to Launch

The decision to launch an AGx is anything but straightforward. Timing, pricing, partner selection, and supply chain readiness all come into play. But what’s often overlooked is the competitive context that frames those decisions.

• Who are the ANDA filers and what are their launch timelines?
• What is their litigation posture, and how aggressive have they been historically?
• How fragmented is the generic competition likely to be in the first 180 days?
• Could we leverage an AGx to deter or delay competitive entry—or mitigate the revenue cliff when loss of exclusivity (LOE) hits?

This is where competitive intelligence becomes indispensable. A robust CI program helps brand teams map the threat landscape, anticipate competitor moves, and assess potential AGx partners. It gives visibility into supply chain constraints, regulatory hurdles, and potential pricing dynamics at launch.

AGx as a Defensive and Offensive Weapon

One of the more interesting shifts I’ve observed is how AGx strategy has evolved from purely defensive to more proactive and offensive.

I’ve seen teams use AGx launches to:

• Undercut “at-risk” generic launches by signaling market saturation.
• Lock in preferred pharmacy contracts before competitors can.
• Set price anchors that shape long-term generic price erosion curves.

None of these tactics happen in a vacuum. They require real-time insights on competitor readiness, wholesaler sentiment, and payer contracting dynamics. It’s not just about what’s happening today, but what’s likely to happen three, six, even twelve months down the road.

Choosing the Right AGx Partner: CI as Due Diligence

Another key area where CI adds value is evaluating potential AGx commercialization partners. Not all generic partners are created equal—some have deeper wholesaler relationships, and others are better at navigating pharmacy benefit manager (PBM) formularies.

CI helps assess:

• Partner reputation and track record in launching AGx products
• Capacity and reliability of manufacturing and distribution
• Strategic fit—are they aligned with your competitive posture?

It’s not just about picking a partner. It’s about picking the right partner for the market you’re about to enter, and competitive intelligence makes that possible.

Lessons from the Trenches

I’ve worked with brand teams who decided not to launch an AGx after seeing that expected generic entry was likely to be delayed due to a bottleneck at FDA or pending patent litigation. I’ve also seen the opposite: teams that pulled the trigger early and captured significant value during the exclusivity window, thanks to early warning from CI that a Paragraph IV challenger was closer to market than anticipated.

In both scenarios, competitive intelligence wasn’t a “nice to have”—it was mission-critical. It helped inform launch timing, partner selection, and pricing strategy, often changing the entire business case.

The Bottom Line

An authorized generics strategy can be one of the most effective tools a brand team has for managing LOE and sustaining revenue. But without the right intelligence, it’s a shot in the dark.

If you’re not embedding competitive intelligence into your AGx strategy—monitoring pipeline filers, legal outcomes, regulatory timelines, market signals—you’re playing checkers while your competitors are playing chess.

AGx isn’t just about surviving post-LOE. With the right CI framework, it can become a strategic growth lever.