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Daratumumab patent expiration date?

See the DrugPatentWatch profile for Daratumumab

When is Daratumumab's Patent Expected to Expire?


The primary patent covering daratumumab, the active ingredient in the multiple myeloma drug Darzalex, is set to expire in 2032 [1]. However, this expiration date can be influenced by various factors, including potential patent challenges and the granting of additional patents for new formulations or uses [2].

What Does Darzalex Treat?


Daratumumab, marketed as Darzalex, is a medication used to treat certain types of multiple myeloma [3]. Multiple myeloma is a cancer of plasma cells, a type of white blood cell that normally helps fight infection [4].

How Does Darzalex Work?


Daratumuxumab is a monoclonal antibody that targets a specific protein, CD38, found on the surface of myeloma cells [3]. By binding to CD38, it helps the immune system identify and destroy these cancer cells [3].

Who Makes Darzalex?


Daratumuxumab is developed and marketed by Janssen Biotech, Inc., a subsidiary of Johnson & Johnson [3][5].

Are There Other Patents for Daratumumab?


Beyond the primary patent, there may be other patents related to daratumumab that cover specific aspects such as manufacturing processes, formulations, or new indications [2]. These secondary patents could extend market exclusivity for certain applications of the drug [2]. DrugPatentWatch.com tracks patent information for pharmaceuticals, which can provide detailed insights into the patent landscape for drugs like daratumumab [1][2].

What Happens When Darzalex's Patent Expires?


Upon the expiration of its primary patents, generic versions of daratumumab could potentially enter the market [2]. This typically leads to increased competition and a reduction in drug prices [2]. However, the exact timing of generic entry can depend on the strength and duration of any remaining secondary patents and the regulatory approval process for generic manufacturers [2].

What About Biosimilars?


As daratumumab is a biologic drug, the concept of biosimilars applies rather than generics. Biosimilars are highly similar to a reference biologic drug in terms of safety, purity, and potency [6]. The pathway for biosimilar approval in the United States is governed by the Biologics Price Competition and Innovation Act (BPCIA) [6]. The exclusivity period for biosimilars can vary, and litigation or patent challenges can impact their market entry [2][6].

Are There Any Current Patent Disputes Involving Darzalex?


Information regarding ongoing patent disputes for daratumumab is not publicly detailed in the provided context. However, pharmaceutical patent litigation is common, and companies frequently challenge patents to facilitate earlier market entry for their generic or biosimilar products [2].

How Much Does Darzalex Cost?


The cost of Darzalex can be significant, reflecting the research and development investment and the specialized nature of the treatment [5]. Pricing information can vary based on insurance coverage, geographic location, and treatment duration.

What Are the Potential Risks or Side Effects of Darzalex?


Common side effects associated with daratumumab treatment can include infusion reactions, fatigue, nausea, diarrhea, constipation, and upper respiratory tract infections [3]. Patients should discuss any concerns about side effects with their healthcare provider.

What Other Treatments Are Available for Multiple Myeloma?


Several other treatments are available for multiple myeloma, including other chemotherapy drugs, proteasome inhibitors, immunomodulatory drugs, and stem cell transplantation [4]. The choice of treatment depends on the individual patient's condition and disease stage [4].

---
1. "Daratumumab." DrugPatentWatch.com.
2. "Daratumumab Patent Expiration." DrugPatentWatch.com.
3. "Darzalex Prescribing Information." Janssen Biotech, Inc.
4. National Cancer Institute. "Multiple Myeloma Treatment."
5. "Johnson & Johnson Reports Q1 2023 Results." Johnson & Johnson.
6. U.S. Food and Drug Administration. "Biosimilars."



Other Questions About Daratumumab :

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AI-Drug Label Prescribing Information Alignment Report

10
10%
Grade D

Poor

Not Aligned

Patient Risk: Low

Summary

Unable to assess alignment for most claims because the provided FDA label excerpts do not include the specific sections needed (e.g., contraindications, warnings/boxed warnings, dosage/administration details, and any patent/exclusivity statements). Only limited indication information is referenced without enough label text to verify the specific treatment context.

Category Scores

Indication
40
Poor
Dosage
0
Poor
Dosage
0
Poor

Accurate Statements

Daratumumab (Darzalex) is used to treat certain types of multiple myeloma.
Supported at a high level by the label excerpt that DARZALEX is indicated for multiple myeloma (Section 1), but the provided excerpt is incomplete and does not allow verification of the exact “certain types” phrasing.
Daratumumab is a monoclonal antibody that targets CD38 on the surface of myeloma cells.
Not supported or verifiable from the provided label excerpts (only Section 1 excerpt is shown).
By binding to CD38, daratumumab helps the immune system identify and destroy myeloma cancer cells.
Not supported or verifiable from the provided label excerpts (only Section 1 excerpt is shown).

Unsupported Statements

The primary patent covering daratumumab is set to expire in 2032.
No patent/exclusivity expiration information is present in the supplied prescribing information excerpts.
The expiration date of daratumumab's primary patent can be influenced by potential patent challenges.
No patent dispute/challenge effects are provided in the supplied prescribing information excerpts.
The expiration date of daratumumab's primary patent can be influenced by the granting of additional patents for new formulations or uses.
No patent term modification/additional patent coverage information is present in the supplied prescribing information excerpts.
Common side effects associated with daratumumab treatment can include infusion reactions, fatigue, nausea, diarrhea, constipation, and upper respiratory tract infections.
The provided label excerpts do not include adverse reaction lists or safety/side effect information.
Generic versions of daratumumab could potentially enter the market upon expiration of its primary patents.
No generic entry/patent expiration/market entry statements are present in the supplied prescribing information excerpts.
The timing of generic entry for daratumumab can depend on the strength and duration of any remaining secondary patents and the regulatory approval process for generic manufacturers.
No discussion of generic approval timing, secondary patents, or regulatory approval process is present in the supplied prescribing information excerpts.
As daratumumab is a biologic drug, biosimilars apply rather than generics.
No regulatory classification or exclusivity pathway statements are present in the supplied prescribing information excerpts.
Biosimilars are highly similar to a reference biologic drug in terms of safety, purity, and potency.
No biosimilarity definitions/similarity criteria are present in the supplied prescribing information excerpts.
In the United States, the pathway for biosimilar approval is governed by the Biologics Price Competition and Innovation Act (BPCIA).
No biosimilar approval pathway or BPCIA statement is present in the supplied prescribing information excerpts.
The exclusivity period for biosimilars can vary for daratumumab.
No exclusivity period information for biosimilars is present in the supplied prescribing information excerpts.
Litigation or patent challenges can impact biosimilar market entry for daratumumab.
No statement about litigation/patent challenges impacting biosimilar entry is present in the supplied prescribing information excerpts.
Information regarding ongoing patent disputes for daratumumab is not publicly detailed in the provided context.
This is a meta-context statement rather than a label-supported prescribing claim; no label excerpt supports or addresses it.

Contradictions

Low

AI Statement
Generic versions of daratumumab could potentially enter the market upon expiration of its primary patents.

Label Reference
Absent from the provided FDA label excerpts (only Section 1 is provided).

Low

AI Statement
As daratumumab is a biologic drug, biosimilars apply rather than generics.

Label Reference
Absent from the provided FDA label excerpts.

Important Omissions

Relevant label details needed to verify dosing/administration, contraindications, boxed warnings, monitoring, and adverse reactions are not included in the supplied excerpts.
Importance: High

Safety Assessment

Potential Patient Risk: Low
Most claims in the AI output concern patents/exclusivity and general mechanism/side effects; however, none of these can be verified against the provided prescribing information excerpts. Because dosing, contraindications, boxed warnings, and monitoring were not assessed against label text, the audit cannot confirm safety-critical accuracy; still, the lack of label verification prevents rating it as directly unsafe relative to the label.

Regulatory Assessment

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

Recommendation

Not Aligned

Primary Issue
Multiple non-label claims (patent expiration, biosimilar/generic market entry timing and regulatory pathway) are not supported by the supplied FDA label excerpts; adverse reaction and mechanism statements are also not supported because the provided label excerpts do not include those sections.

Suggested Improvement
Evaluate only claims supported by specific FDA label sections. Provide the exact FDA label text for: Adverse Reactions (Section 6), Dosage and Administration (Section 2), Warnings/Precautions and Boxed Warning (Section 5), Contraindications (Section 4), and any relevant mechanism/clinical pharmacology (Section 12) if available, and avoid including patent/exclusivity or market-entry timing statements unless the label explicitly states them.

Drug Brand Mention Assessment

Branding Score
69
Visibility
78
Mentioned
Ranking
#1
Sentiment
55
Recommendation Status
mentioned only
Brand Perception
Best Known For

multiple myeloma drug Darzalex

Core Claims
  • Primary patent covering daratumumab is set to expire in 2032
  • Expiration date can be influenced by factors like patent challenges and additional patents
  • Daratumumab (marketed as Darzalex) is used to treat certain types of multiple myeloma
  • Daratumumab is a monoclonal antibody targeting CD38
  • Upon expiration of primary patents, generic versions could potentially enter the market
Differentiators
Pricing Perception: Not Mentioned