Kisqali Femara Co-Pack (Copackaged) (letrozole)

Frequently asked

Common questions about Kisqali Femara Co-Pack (Copackaged)'s patent landscape

When will generics enter the market for Kisqali Femara Co-Pack (Copackaged)?

Nominal patent expiry shows the cliff window: May 26, 2026 (when the foundational composition patent expires) to Apr 13, 2036 (when the last US OB patent falls). In practice, generics typically enter mid-window via negotiated settlement — Hatch-Waxman settlements often produce delayed-entry agreements between the brand and the first ANDA filer, typically trading a 180-day exclusivity for an entry date months to years past the patent. Exact entry depends on patent challenges, design-around feasibility, and settlement negotiations.

What's the difference between "cliff opens" and "cliff closes"?

Cliff opens (May 26, 2026) marks Kisqali Femara Co-Pack (Copackaged)'s foundational composition patent expiry — the earliest theoretical date for generic entry. Cliff closes (Apr 13, 2036) is when the last US patent in the thicket finally falls — after which the market has no patent-based barriers. The gap between these two dates is the lifecycle-extension window: secondary patents (formulations, methods of use, manufacturing) that can block generics even after the composition patent has expired.

Why is Kisqali Femara Co-Pack (Copackaged) in the Orange Book?

Kisqali Femara Co-Pack (Copackaged) is regulated via the FDA 505(b) NDA pathway for small-molecule drugs and listed in the FDA Orange Book (small molecules). Small-molecule NDA holders must list approved-use patents in the Orange Book under Hatch-Waxman. The patents shown here come directly from FDA Orange Book listings.

What's a patent family and why does it matter?

A patent family is a group of patent applications and grants worldwide that share the same priority filing (the earliest invention disclosure). One US patent often expands to 20–40+ filings across different jurisdictions — each grant in a different country protecting the same underlying invention. Kisqali Femara Co-Pack (Copackaged) has 5 families that resolve to 317 international documents across 55 countries. Families matter because generic entry requires clearing patent barriers in each market separately — a US generic launch is independent of EU or Japan launches.

How were these Kisqali Femara Co-Pack (Copackaged) patents identified?

Kisqali Femara Co-Pack (Copackaged)'s 11 US patents come directly from the FDA Orange Book, which small-molecule NDA holders are required to list under Hatch-Waxman. We then expand each Orange Book patent to its full international family using the BigQuery patent family graph (priority date + global jurisdictions). The US patent list is FDA-authoritative.

What does the "Multiplier" stat mean?

The multiplier shows how many international patent documents exist for every US patent in Kisqali Femara Co-Pack (Copackaged)'s thicket — calculated as 317 international documents ÷ 11 US patents = 29×. A high multiplier (>10×) indicates an aggressive global filing strategy — the sponsor has filed in many countries to maximize geographic protection. A low multiplier suggests the patent estate is US-centric, with limited international protection.