Actavis Filed to Produce Generic Avinza

The generic manufacturer challenged the patent held by King Pharmaceuticals, sparking an imminent legal standoff.

Updated on Sept. 22, 2026 in Healthcare

Isometric editorial illustration of a single empty pharmaceutical vial on a clinical surface, representing pharmaceutical patent disputes. — Actavis filed an FDA application to produce a generic version of the pain medication Avinza, triggering a planned patent defense from King Pharmaceuticals. AI Illustration. Upload story photo >

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Should drug manufacturers be permitted to legally challenge generic competition to protect their existing patents?

In September 2007, Actavis submitted an application to the U.S. Food and Drug Administration to produce a generic version of the pain medication Avinza. The move prompted patent holder King Pharmaceuticals to signal that it would initiate litigation to defend its intellectual property rights.

Why it matters

King Pharmaceuticals maintains a strict protocol to challenge every generic filing against its products to protect revenue streams. For operators in highly regulated sectors, this highlights the high stakes of patent defense and the financial impact of maintaining exclusive market access.

Avinza generated $35 million in revenue in Q2 2007, a significant increase from $9 million in Q1 2007. King Pharmaceuticals previously acquired the drug patent from Ligand Pharmaceuticals for $246 million.

The players

Actavis

An international pharmaceutical company specializing in the development and production of generic medications.

King Pharmaceuticals

A United Kingdom-based pharmaceutical firm that maintains a aggressive strategy of enforcing product patents against generic competitors.

Ligand Pharmaceuticals

A San Diego-based biopharmaceutical company that previously held and sold the patent rights for Avinza.

The details

Actavis initiated the process by filing an abbreviated application with the FDA, a standard move for generic manufacturers seeking market entry. King Pharmaceuticals intends to use its established enforcement protocol to block the generic version, with legal proceedings expected to begin within 45 days. The dispute will ultimately be settled in a U.S. court, determining if the generic drug can enter the market before the patent's 2017 expiration.

Q1 2007: Avinza generated $9 million in revenue.
Q2 2007: Avinza generated $35 million in revenue.
September 2007: Actavis filed its application with the FDA.
November 2026: The projected window for legal enforcement initiation.
November 25, 2017: The patent on Avinza is scheduled to expire.

Market Landscape

This dispute follows the standard pattern of patent litigation established by the Hatch-Waxman Act, where generic filings trigger mandatory legal challenges from incumbent manufacturers. It highlights the recurring industry trend where pharmaceutical firms aggressively defend branded drugs until the expiration date.

Operators in regulated industries should note that intellectual property disputes often lead to significant litigation costs that can impact short-term margins. Maintain rigorous oversight of patent expiration dates and budget for potential legal contingencies if market exclusivity is challenged.

The takeaway

The rapid growth in Avinza revenue likely invited this generic challenge, proving that market success often accelerates legal scrutiny. Executives should track competitors' filings and ensure legal counsel is prepared to defend intellectual property on a strict schedule.