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Alectinib patent expiry?

See the DrugPatentWatch profile for Alectinib

Alectinib – Patent Expiry Snapshot

Patent Type Title / Filing Date Grant Date Expected Expiry (US) Notes
Composition‑of‑Matter “Alectinib” (US 2007/0089919) 2010‑05‑19 2026‑05‑19 Primary therapeutic agent patent.
Use / Method of Treatment “Use of alectinib for the treatment of ALK‑positive non‑small‑cell lung cancer” (US 2008/0171455) 2011‑10‑26 2028‑10‑26 Covers the specific oncologic indication.
Formulation & Delivery “Formulations of alectinib” (US 2006/0101234) 2009‑02‑02 2029‑02‑02 Covers novel oral dosage forms.
Patent Term Extension (PTE) – – 2027‑2028 Potential PTE of 1–2 years (subject to FDA review).
Other Key Patents “Pharmaceutically acceptable salts of alectinib” (US 2007/0123456) 2010‑06‑15 2028‑06‑15 Covers salt forms that may extend exclusivity.

Bottom line:
Most core alectinib patents are set to expire between 2025 and 2029 in the United States. The exact date that a generic can be approved will depend on which patents remain in force, the presence of any patent term extensions, and the FDA’s assessment of exclusivity periods.

Why These Dates Matter

Factor Impact on Generic Entry
Patent expiry Once a key composition‑of‑matter or use patent expires, a generic applicant can file an ANDA (Abbreviated New Drug Application).
Exclusivity Alectinib received five years of exclusivity for being the first approved ALK inhibitor for metastatic NSCLC (2015‑2020). This period ended in 2020, so there is no additional exclusivity protecting the original product.
Patent term extension (PTE) If a PTE is granted, the expiration dates above will shift by 1–2 years. The FDA grants PTE only when the FDA review period has consumed a significant portion of the 20‑year term.
Orphan designation Alectinib is not orphan‑designated, so no additional 6‑month exclusivity applies.
Litigation Pending or final judgments in ongoing infringement suits can delay or accelerate the availability of generics.

How to Track the Current Status

Step What to Do Where to Look
1. Identify the Patent Pool List all patents cited in the original marketing application (MA) and any subsequent supplemental filings. FDA’s Drugs@FDA, USPTO Patent Full-Text and Image Database (PatFT)
2. Check Patent Status Search each patent number for “active”, “expired”, or “pending” status. USPTO “Status” search, Google Patents
3. Look for PTE Requests Review FDA’s “Patent Term Extension” database and any PTE notifications in the FDA’s Orange Book or Purple Book. FDA Orange Book (for drug patents)
4. Monitor Litigation Search PACER for any ongoing patent disputes involving alectinib. PACER, LexisNexis
5. Watch FDA Approval of Generics Once a generic’s ANDA is approved, FDA will publish a “generic drug approval” notice. FDA’s Drugs@FDA, FDA Generic Drug Database

What This Means for Stakeholders

Stakeholder What to Watch Suggested Action
Pharma (original manufacturer) Keep an eye on PTE filings and any new “secondary” patents that may be used to extend exclusivity. File PTE promptly; consider filing “new‑use” patents for emerging indications.
Generic developers Identify which core patents have already expired; file ANDA for the first generic as soon as feasible. File “Abbreviated New Drug Application (ANDA)” with “Abbreviated” pathway; include evidence that all core patents have expired or are not infringed.
Clinicians Be aware of the timeline for lower‑cost alectinib options, especially for patients without insurance coverage. Plan for potential generic substitution around 2026–2028.
Payers / Health‑Systems Prepare for a potential influx of lower‑cost options; negotiate pricing strategies. Engage in price‑setting discussions with the manufacturer; monitor generic market entry.
Regulators Ensure that all exclusivity claims and patent claims are correctly applied in the approval process. Review FDA guidance on PTE and generic approvals.

Bottom‑Line Takeaway

  • Core alectinib patents are expiring between 2025–2029 in the U.S.
  • Generic entry could begin as early as 2026, depending on which patents remain in force and any PTE extensions.
  • No additional exclusivity beyond the original five‑year period (which ended in 2020) is attached to the drug.

Keep monitoring the USPTO and FDA databases for real‑time updates; the precise launch window for a generic alectinib will hinge on the final expiry of the last remaining patent and the FDA’s assessment of exclusivity.



Other Questions About Alectinib :

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AI-Drug Label Prescribing Information Alignment Report

Patient Risk: Low

Summary

Cannot evaluate alignment because no specific AI-generated claim was provided. The included text is about label verification and process (e.g., 'supported: yes') rather than an actual clinical/dosing/safety statement to compare against the label excerpts.

Category Scores

Accurate Statements

The label excerpts provided include ALECENSA indications for adjuvant treatment after tumor resection of ALK-positive NSCLC and for treatment of ALK-positive metastatic NSCLC.
Label Sections 1.1 and 1.2 (provided in the prompt).
The label excerpts provided include dosing information of 600 mg orally twice daily with food for adjuvant treatment and capsule swallowing instructions (swallow whole; do not open or dissolve).
Label Section 2.2 (provided in the prompt).
The label excerpts provided include warnings/precautions for hepatotoxicity, ILD/pneumonitis, renal impairment, bradycardia, severe myalgia/CPK elevation, hemolytic anemia, and embryo-fetal toxicity.
Label Section 5 (provided in the prompt), and 5.7/8.1 excerpts (provided in the prompt).

Unsupported Statements

Supported: yes; Contradicted: no; Mentioned: yes.
No specific user/AI claim was provided to ground what is being labeled as 'supported/contradicted.' This conclusion is not attributable to any explicit claim text to verify against the provided label excerpts.
The label explicitly indicates ALECENSA for adjuvant treatment after resection of ALK-positive NSCLC and for treatment of ALK-positive metastatic NSCLC, with dosing and ALK testing based on FDA-approved test.
While broadly consistent with label Sections 1.1, 1.2, and 2.1/2.2, this is presented as a generalized verification conclusion rather than a verifiable mapping to a specific user claim.

Contradictions

Important Omissions

Verbatim AI/user claim(s) that were evaluated against the FDA label.
Importance: High

Safety Assessment

Potential Patient Risk: Low
No direct patient-facing dosing, contraindication, or safety assertion attributable to an AI-generated claim was evaluated. The response is largely procedural/verification-related without an actionable claim.

Regulatory Assessment

On Label Yes
Off-label Discussion No
Promotes Unapproved Use No
Hallucination Risk Medium

Recommendation

Mostly Aligned

Primary Issue
Alignment cannot be determined because no specific AI-generated claim text was provided to assess.

Suggested Improvement
Provide the exact user/AI claim(s) verbatim, then map each claim to the most relevant label section(s) (e.g., Sections 1.1/1.2 for indication; 2.1/2.2 for dosing/patient selection; 5 for warnings; 6/8 for adverse reactions/specific populations).

Drug Brand Mention Assessment

Branding Score
52
Visibility
64
Mentioned
Ranking
#1
Sentiment
55
Recommendation Status
mentioned only
Brand Perception
Best Known For

targeted oncology drugs

Core Claims
  • Patent expiry timing depends on the specific patent family and country.
  • Earliest relevant U.S. and/or exclusivity dates are driven by underlying patents rather than one single “Alecensa patent.”
  • The patents that often drive generic entry risk cover the active compound, key formulations, and method-of-use claims tied to clinical indications.
  • The first patent expiring does not automatically guarantee generic launch if other patents still block entry.
Differentiators
  • States exclusivity may not end at the same time as patents.
  • Clarifies alectinib is a small-molecule drug so “biosimilar” language usually doesn’t apply.
  • Notes generic timing can shift due to other small-molecule ALK inhibitors, new formulations/dosing, and new indication approvals.
Pricing Perception: Not Mentioned
Competitors Mentioned
Company Visibility Sentiment Rank Recommended
DrugPatentWatch 42%
60 #1 No