BioTech IP Review

While AbbVie’s full immunology patent estate includes many related filings, one of the core U.S. composition-of-matter patents for upadacitinib underpins Rinvoq’s exclusivity. According to regulatory listings, patents covering upadacitinib (Rinvoq) include U.S. Patent No. 11,564,922 and others listed for the product in the FDA’s Orange Book.

Filing Date:
Filed prior to issuance — typical priority filings date back several years before grant (common for drug composition/method patents), with this one issued in January 2023.

Expected Exclusivity Period:
Composition-of-matter patents covering upadacitinib in the U.S. are expected to expire around 2033, and additional related patents extend protection — many running into the mid-2030s — helping delay generic competition beyond 2023.

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What This Patent Covers

1. Composition-of-matter (Active Ingredient Protection)
The core patents protect the chemical compound upadacitinib itself — a Janus kinase (JAK) inhibitor used in Rinvoq for immunology indications like rheumatoid arthritis, atopic dermatitis, ulcerative colitis, and Crohn’s disease — giving AbbVie exclusive rights to make and sell the molecule in the U.S. until patent expiry.

2. Methods of Treatment
The specific patent example (11,564,922) covers methods of treating Crohn’s disease and ulcerative colitis using upadacitinib, which broadens legal protection to include specific clinical uses that are important to the drug’s label and market value.

3. Formulations & Additional Claims (Typical for Rinvoq Patents)
Beyond composition and treatment methods, AbbVie’s portfolio includes numerous related patents on tablet formulations, dosing regimens, and manufacturing processes, which further fortify Rinvoq’s exclusivity against generics — a strategy that can prolong market protection even after the base composition patent expires.

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Why This Patent is Important

• Revenue impact: Rinvoq was a key growth driver for AbbVie, especially as Humira’s patents expired and biosimilars entered the U.S., reducing Humira’s share of sales.
• Extended exclusivity: Although the core composition patent have been used in litigation and settlements to block or postpone generic competition, supporting billions in continued revenue.

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Summary: The upadacitinib composition and method patent (e.g., U.S. Patent No. 11,564,922) was among AbbVie’s most important patents. It not only protects the chemical identity of Rinvoq but also covers critical methods of treating immune-mediated diseases — anchoring the drug’s blockbuster sales as AbbVie navigated the post-Humira landscape.