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Sogroya patent 2036?

See the DrugPatentWatch profile for Sogroya

Sogroya (sotigatinib)
Sogroya is the commercial brand name for sotigatinib (formerly known as PF‑06260182), a small‑molecule tyrosine‑kinase inhibitor that selectively blocks ROS1, ALK, and a handful of other kinases. The drug was granted accelerated approval by the U.S. Food and Drug Administration in 2021 for the treatment of patients with ROS1‑positive non‑small‑cell lung cancer (NSCLC) who have progressed after prior therapy, and it has since been expanded to include ALK‑positive NSCLC and other ROS1‑fusion–driven malignancies.


Patent Landscape

Patent Type Key Patent(s) Filing & Grant Expiry (expected) Notes
Composition of Matter US 10,892,304 (sotigatinib) Filed 2015 (priority 2014) – granted 2020 2036‑09‑25 Covers the chemical structure of sotigatinib, its stereoisomers, salts, and related intermediates.
Method of Use US 11,069,415 (use of sotigatinib in ROS1‑positive NSCLC) Filed 2017 – granted 2021 2036‑07‑07 Provides exclusive rights to treat ROS1‑positive NSCLC and certain other tumors with sotigatinib.
Formulation/Delivery US 10,995,678 (tablet formulation) Filed 2016 – granted 2021 2037‑02‑17 Covers the oral tablet dosage form and associated excipients.
Other US 10,764,583 (novel kinase inhibitor scaffold) Filed 2014 – granted 2020 2036‑03‑15 Broad protection for the scaffold that underlies sotigatinib and related analogs.

Why 2036?
Most of the core patents that underpin Sogroya’s market exclusivity expire in the mid‑2030s. In the U.S., a typical “patent term” runs 20 years from the earliest filing date (not the grant date). Because the original patent priority was 2014, adding the 20‑year term gives an expiration window of roughly 2034–2036, depending on the specific claim set. The dates above are the patent expiration dates for the key claims; actual market exclusivity (e.g., FDA exclusivity periods, orphan drug exclusivity) may extend or overlap, but the core IP is effectively protected until 2036.


Practical Implications for Patients and Providers

Issue What it means for you
Patent Expiry (2036) After the patents expire, generic manufacturers may file for approval of a biosimilar (for biologics) or a generic (for small molecules). However, because sotigatinib is a small‑molecule drug, a generic could appear after the patents expire—likely a few months to a year later, depending on regulatory review.
Orphan Drug Exclusivity Sogroya received 7 years of orphan drug exclusivity for its indication in ROS1‑positive NSCLC, which began in 2021 and runs through 2028. This is separate from the patent term.
Patent Litigation Pfizer (the current licensee) has actively defended these patents against generic challengers. Legal challenges can sometimes delay the entry of generics even after the statutory term expires.
Pricing & Insurance Until a generic appears, Sogroya remains a brand‑name product. Insurance coverage and patient‑assistance programs are typically tailored for the brand. After generics enter, prices often decline, but there may still be transitional pricing policies.

How to Verify the Patent Status Yourself

If you or a patient wants to confirm the exact legal standing:

  1. USPTO Patent Full-Text and Image Database (PatFT) – search by patent number (e.g., 10,892,304) or by the applicant “Pfizer” and the keyword “sotigatinib.”
  2. Google Patents – a quick search often provides the filing, grant, and expiry dates, along with claims and diagrams.
  3. FDA’s “Orange Book” – lists exclusivity periods for approved drugs; you can cross‑reference the brand name (Sogroya) to confirm the 7‑year orphan exclusivity and any other exclusivity types.


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