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Sufentanil patent expiry?

See the DrugPatentWatch profile for Sufentanil

When does the sufentanil patent expire?

The exact patent-expiry date for sufentanil depends on which specific patent (and which country or regulatory market) you mean. Patent expiry is not one single date for all sufentanil products because different patents can cover different aspects such as the active ingredient, specific formulations (e.g., certain concentrations or delivery systems), manufacturing, or related medical uses, and each patent has its own term and status.

Why there isn’t one universal “sufentanil patent expiry” date

Search results for “sufentanil patent expiry” often vary because:
- Sufentanil is sold in multiple product forms and strengths, and formulation-specific patents may differ by product.
- Patent status can differ by jurisdiction (e.g., US vs. EU vs. UK), with different filing dates and legal term calculations.
- Some exclusivity is driven by regulatory exclusivity (not just patents). That can delay generic or biosimilar competition even after a relevant patent ends.

How to find the right expiry date for the product you care about

To determine the correct expiry for “sufentanil,” you typically need:
- The exact brand name or label (and formulation/strength).
- The country/market.
- The marketing authorization holder, so you can identify the patents listed for that product in that jurisdiction.

From there, the expiry date is calculated from the specific patent’s priority/filing timeline and its legal events (if any), then cross-checked against any additional regulatory exclusivities.

What happens after patent expiry (and what could still block generics)

Even if a key patent expires, entry of a generic version can still be delayed by:
- Remaining unexpired patents covering the same product (often formulation and method-of-use patents).
- Regulatory exclusivity that is independent of patent status.
- Ongoing litigation or regulatory stays that can pause approval timelines.

Quick check: what you should share to get a precise date

If you tell me:
1) the country (e.g., US or EU),
2) the exact product (brand name and strength/form), and
3) whether you mean drug substance patents or a specific formulation (if known),
I can narrow down which patent family you likely mean and what the expected expiry window is for that market.

Sources

I don’t have the provided patent/regulatory records in your prompt, so I can’t cite specific sufentanil patent expiry dates reliably yet. If you paste a link or the patent numbers/brand name you’re looking at, I can calculate and explain the expiry for that exact case.

AI-Drug Label Prescribing Information Alignment Report

60
60%
Grade C

Partial

Partially Aligned

Patient Risk: Low

Summary

The evaluation notes that no FDA-approved sufentanil labeling sections were provided for verification, limiting assessment to label content. Claims about patent expiry/regulatory exclusivity are not supported by the provided labeling data.


Category Scores


Accurate Statements

The response correctly notes that no FDA-approved sufentanil labeling sections were provided for verification.
Label Section Scores indicate 'absent_from_label' and note that no sections are available to support patent or safety claims.

Unsupported Statements

Claims about patent expiry processes and regulatory exclusivities are not supported by the provided labeling and relate to regulatory/commercial data rather than the label.
Patent expiry and exclusivity claims are not part of FDA labeling.

Contradictions


Important Omissions

Contraindications, Boxed Warnings, Warnings/Precautions, Adverse Reactions, Dosage and Administration, Use in Specific Populations (Pregnancy, Pediatrics, Nursing) were not provided in the labeling to verify.
Importance: High

Safety Assessment

Potential Patient Risk: Low
No label data available to assess safety from the provided labeling.

Regulatory Assessment

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

Recommendation

Partially Aligned

Primary Issue
No current FDA-approved sufentanil labeling sections were provided to verify safety claims.

Suggested Improvement
Provide the current FDA-approved labeling with sections and numbers; cite exact sections. Include Contraindications, Boxed Warnings, Warnings/Precautions, Adverse Reactions, Dosage and Administration, Use in Specific Populations (Pregnancy, Pediatrics, Nursing). Include dosing, monitoring, and risk statements as per label.

Drug Brand Mention Assessment

Branding Score
0
Visibility
0
Mentioned
Ranking
Sentiment
0
Recommendation Status
not mentioned
Brand Perception
Best Known For


Core Claims
Differentiators

Pricing Perception: Not Mentioned