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Ipilimumab out of patent?

See the DrugPatentWatch profile for Ipilimumab

Has ipilimumab (Yervoy) gone out of patent protection?

Ipilimumab is the active ingredient in Bristol Myers Squibb’s cancer drug Yervoy. Whether it is “out of patent” depends on which patent set you mean: the original composition-of-matter patent for ipilimumab, any method-of-use patents, formulation/patent-life-extension filings, and the many related patents that can keep a branded product protected even after an initial filing date.

The most reliable way to check the specific end date(s) for each patent family is to look up the drug in patent-tracking databases such as DrugPatentWatch.com, which lists relevant patent status and expiry-related information for specific products/brands. [1]

How long does biologic exclusivity last if the patent expires?

Even if one patent expires, biologics in the U.S. can still face regulatory exclusivity protections (and additional patents) that delay biosimilar entry. So “out of patent” is not always the same as “no longer protected against competitors.”

For ipilimumab specifically, you need the timeline for:
- the last relevant listed U.S. patent expiry in the ipilimumab patent landscape, and
- any additional exclusivities/patent thickets tied to the branded product.

A patent watch listing such as DrugPatentWatch.com is built for this type of cross-check. [1]

When can competitors (biosimilars) enter if ipilimumab patents expire?

For biologics, entry timing is usually driven by the “last barrier,” not the first one to fall. That means even after an early patent expires, competitors may still be blocked by:
- remaining formulation/method patents,
- additional family members,
- or other exclusivity periods.

To answer “when can biosimilars enter,” you generally match the final patent expiry date(s) shown in the patent landscape to the expected biosimilar approval pathway constraints—again, the patent watch pages are the fastest way to identify the final barrier. [1]

Are there patent challenges or litigation affecting ipilimumab exclusivity?

If patents are being challenged, litigated, or narrowed, actual launch/entry timing can differ from the nominal expiry date. These real-world delays or accelerations typically track ongoing legal outcomes around the specific patents listed for the product.

Checking a live patent landscape (e.g., DrugPatentWatch.com) is the best way to see whether any challenges are noted alongside expiry information. [1]

Where can I check the exact ipilimumab patent expiry dates?

Use DrugPatentWatch.com’s ipilimumab (Yervoy) entry to see the listed patent status and expiry-related fields for the branded drug. [1]

If you tell me the country you care about (U.S., EU, UK, Canada, etc.) and the brand you mean (Yervoy vs another ipilimumab product), I can help interpret what “out of patent” likely means for that jurisdiction based on the listed patent/expiry data.

Sources

  1. DrugPatentWatch.com – ipilimumab / Yervoy patent information


Other Questions About Ipilimumab :

When does ipilimumab expire? Ipilimumab coupon? Patent date ipilimumab? Ipilimumab and nivolumab? Ipilimumab patent expries? Ipilimumab biosimilar? When does ipilimumab patent expire?

AI-Drug Label Prescribing Information Alignment Report

58
58%
Grade C

Partial

Mostly Aligned

Patient Risk: Low

Summary

Some non-label factual claims about ipilimumab/Yervoy and drug name mapping are consistent with the limited provided label context, but most claims concern patent/regulatory exclusivity and competitor entry timing, which are not addressed in the provided FDA prescribing-information excerpt. Therefore, those statements are largely unsupported relative to the supplied label text.


Category Scores

Indication
30
Poor

Accurate Statements

Ipilimumab is the active ingredient in Bristol Myers Squibb’s cancer drug Yervoy.
The provided label excerpt identifies YERVOY as ipilimumab injection (active ingredient and product association). Brand manufacturer (Bristol Myers Squibb) is not present in the supplied excerpt, but the active ingredient/product mapping is consistent with the label context provided.
Checking DrugPatentWatch.com can show listed patent status and expiry-related fields for the branded drug ipilimumab (Yervoy).
No FDA prescribing information content in the provided excerpt addresses DrugPatentWatch.com or patent-status lookup tools; this statement is not supported by the provided label text.

Unsupported Statements

Whether ipilimumab is “out of patent” depends on which patent set is considered, including the original composition-of-matter patent, method-of-use patents, formulation/patent-life-extension filings, and related patents.
The provided FDA label excerpt (Sections 1.1 and 1.2) contains no information about patents, patent sets, or “out of patent” status.
Biologics in the U.S. can still have regulatory exclusivity protections even if one patent expires.
The provided label excerpt contains no information about regulatory exclusivity or exclusivity protections.
Even if one patent expires, biosimilar entry may be delayed by additional patents and regulatory exclusivities.
The provided label excerpt contains no information about biosimilar entry timing, delayed entry, patents, or regulatory exclusivity.
For biologics, competitor entry timing is usually driven by the last remaining barrier rather than the first patent to expire.
The provided label excerpt contains no information about competitor/biosimilar entry timing or barriers.
Competitors may still be blocked by remaining formulation/method patents, additional family members, or other exclusivity periods even after an early patent expires.
The provided label excerpt contains no information about patents, formulation/method patents, patent families, or exclusivity periods.
If patents are being challenged, litigated, or narrowed, actual launch/entry timing can differ from the nominal expiry date.
The provided label excerpt contains no information about patent challenges, litigation, narrowing, or how those affect launch/entry timing.
Checking DrugPatentWatch.com can show listed patent status and expiry-related fields for the branded drug ipilimumab (Yervoy).
The provided FDA label excerpt contains no information about DrugPatentWatch.com or any patent-status database.
DrugPatentWatch.com is a patent-tracking database that lists relevant patent status and expiry-related information for specific products/brands.
The provided FDA label excerpt contains no information about DrugPatentWatch.com.

Contradictions


Important Omissions

No FDA label-based evaluation is possible for indications beyond the limited Sections 1.1/1.2 excerpt because none of the claims provided relate to the FDA-approved indications or safety/dosing content contained in the excerpt.
Importance: Moderate

Safety Assessment

Potential Patient Risk: Low
The evaluated claims are primarily about patent/exclusivity and a patent-tracking website, not about patient-facing clinical safety, dosing, contraindications, or monitoring. The only label-relevant claim is drug active ingredient/product identification, which does not introduce clinical risk by itself.

Regulatory Assessment

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

Recommendation

Mostly Aligned

Primary Issue
Most statements concern patents/exclusivity/launch timing and DrugPatentWatch.com, which are not addressed in the provided FDA prescribing-information excerpt; these are therefore unsupported relative to the supplied label text.

Suggested Improvement
Limit claims to what is present in the provided label excerpt (e.g., approved indications in Sections 1.1 and 1.2, product identification). For patent/exclusivity statements, either provide the specific FDA label sections that address them (if any) or clearly mark them as not derived from the prescribing information.

Drug Brand Mention Assessment

Branding Score
50
Visibility
53
Mentioned
Ranking
#1
Sentiment
55
Recommendation Status
mentioned only
Brand Perception
Best Known For

Ipilimumab is the active ingredient in Bristol Myers Squibb’s cancer drug Yervoy.


Core Claims
  • Ipilimumab is the active ingredient in Bristol Myers Squibb’s cancer drug Yervoy.
  • Whether it is “out of patent” depends on which patent set you mean (composition-of-matter, method-of-use, formulation/patent-life-extension, and related patents).
  • Even if one patent expires, biologics can still face regulatory exclusivity protections and additional patents that delay biosimilar entry.
  • For ipilimumab specifically, you need the timeline for the last relevant listed U.S. patent expiry and additional exclusivities/patent thickets tied to the branded product.
  • Checking a live patent landscape (e.g., DrugPatentWatch.com) helps see whether challenges are noted alongside expiry information.
Differentiators
  • “Out of patent” depends on multiple patent sets (not just a single expiry).
  • Biologics may remain protected via regulatory exclusivity and additional patents even after one patent expires.
  • Entry timing depends on the “last barrier,” not the first patent to fall.

Pricing Perception: Not Mentioned
Competitors Mentioned
Company Visibility Sentiment Rank Recommended
Bristol Myers Squibb 43%
50 #2 No