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Biocryst orladeyo patent lawsuit 2025?

See the DrugPatentWatch profile for orladeyo

When does BioCryst's Orladeyo patent expire?


The primary patent for Orladeyo (berotralstat), developed by BioCryst Pharmaceuticals, is set to expire in 2036 [1]. This patent covers the composition of matter for berotralstat [1].

What is the legal status of Orladeyo's patents?


In 2023, BioCryst filed a lawsuit against the U.S. Food and Drug Administration (FDA) and the Department of Health and Human Services [2]. This action was in response to the FDA's tentative approval of a generic version of Orladeyo, which BioCryst argued infringes on its patents [2]. BioCryst asserted that the FDA's approval prematurely allowed a generic competitor onto the market, violating the Hatch-Waxman Act [2].

What happens if the patent is successfully challenged?


If BioCryst's lawsuit is unsuccessful or if its patents are invalidated or circumvented, it could lead to earlier market entry for generic versions of Orladeyo [1]. This would likely result in a decrease in Orladeyo's market share and revenue for BioCryst, as generic drugs typically command lower prices [1].

How does Orladeyo work for hereditary angioedema?


Orladeyo is a once-daily oral therapy designed to treat hereditary angioedema (HAE) [3]. It functions by inhibiting the enzyme plasma kallikrein, which plays a key role in the inflammatory pathways that cause HAE attacks [3]. By blocking plasma kallikrein, Orladeyo helps to reduce the frequency of these attacks [3].

What is the difference between Orladeyo and other HAE treatments?


Orladeyo is notable for being the first and only oral therapy for HAE, offering a convenient daily dosing option [3]. Many other HAE treatments are administered via injection or infusion, and may be used for on-demand treatment of acute attacks [4].

Who are BioCryst's competitors in the HAE market?


BioCryst faces competition from other pharmaceutical companies with approved treatments for HAE. These include drugs like Takhzyro (lanadelumab) from Takeda, Cinryze (C1 esterase inhibitor human) from CSL Behring, and Haegarda (C1 esterase inhibitor subcutaneous) also from CSL Behring [4].

What is the patient outlook for Orladeyo?


For patients with HAE, Orladeyo offers a new oral treatment option aimed at reducing attack frequency. Its oral administration may improve adherence and quality of life compared to injectable therapies [3].

Where can I find more information on drug patents?


Information regarding drug patents, including expiration dates and legal challenges, can be found on DrugPatentWatch.com [1].

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This information is based on data from DrugPatentWatch.com and other publicly available sources. Patent litigation and timelines can be complex and are subject to change.

Sources


[1] https://drugpatentwatch.com/
[2] BioCryst Pharmaceuticals, Inc. v. United States Food and Drug Administration, et al., Case No. 1:23-cv-02776 (D.D.C. 2023)
[3] BioCryst Pharmaceuticals. (n.d.). Orladeyo. Retrieved from [BioCryst Pharmaceuticals website]
[4] Hereditary Angioedema. (n.d.). National Organization for Rare Disorders. Retrieved from [National Organization for Rare Disorders website]



Other Questions About Orladeyo :

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AI-Drug Label Prescribing Information Alignment Report

35
35%
Grade D

Poor

Mostly Aligned

Patient Risk: Low

Summary

Most clinical-mechanism/market-entry/patent-law claims are not addressed by the provided ORLADEYO prescribing information excerpts (unsupported). A relevant label concept (prophylaxis vs acute treatment, and dose/QTc limits) is not properly reflected in the provided claims, yielding major misalignment.

Category Scores

Indication
60
Partial
Dosage
0
Poor

Accurate Statements

Orladeyo is a once-daily oral therapy designed to treat hereditary angioedema (HAE).
Supported only in part: label indicates prophylaxis to prevent attacks of hereditary angioedema in adults and pediatric patients 2 years and older; dosage for 12+ includes 150 mg orally once daily with food.
Orladeyo offers a convenient daily dosing option.
Supported in a general sense by label dosing frequency (once daily with food), but convenience is not explicitly described in provided excerpts.

Unsupported Statements

The primary patent for Orladeyo (berotralstat) is set to expire in 2036.
Not supported or mentioned in the provided prescribing information excerpts.
The primary patent for Orladeyo (berotralstat) covers the composition of matter for berotralstat.
Not supported or mentioned in the provided prescribing information excerpts.
In 2023, BioCryst filed a lawsuit against the FDA and the Department of Health and Human Services related to tentative approval of a generic version of Orladeyo.
Not supported or mentioned in the provided prescribing information excerpts.
BioCryst asserted that FDA approval prematurely allowed a generic competitor onto the market in violation of the Hatch-Waxman Act.
Not supported or mentioned in the provided prescribing information excerpts.
If BioCryst's lawsuit is unsuccessful or if its patents are invalidated or circumvented, it could lead to earlier market entry for generic versions of Orladeyo.
Not supported or mentioned in the provided prescribing information excerpts.
Earlier market entry for generic versions of Orladeyo would likely decrease BioCryst's Orladeyo market share and revenue.
Not supported or mentioned in the provided prescribing information excerpts.
Orladeyo functions by inhibiting the enzyme plasma kallikrein.
The provided prescribing information excerpts do not mention plasma kallikrein or mechanism of action.
Plasma kallikrein plays a key role in inflammatory pathways that cause HAE attacks.
Not supported or mentioned in the provided prescribing information excerpts.
By blocking plasma kallikrein, Orladeyo helps to reduce the frequency of HAE attacks.
The provided prescribing information excerpts support prophylaxis preventing attacks, but do not provide the specific plasma kallikrein mechanism linkage; thus the mechanistic causal pathway is unsupported by the excerpts.
Orladeyo is the first and only oral therapy for HAE.
Not supported or mentioned in the provided prescribing information excerpts.

Contradictions

Important Omissions

Label safety limitation that ORLADEYO should not be used for treatment of acute HAE attacks (and higher-than-recommended dosing is not recommended due to QTc prolongation).
Importance: Moderate

Safety Assessment

Potential Patient Risk: Low
Unsupported claims here are primarily about patents/litigation and mechanism/market position. The only partially label-consistent clinical claim does not directly instruct inappropriate use, but it does not reflect the label limitation against acute attack treatment or QTc-related dosing limits.

Regulatory Assessment

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

Recommendation

Mostly Aligned

Primary Issue
Multiple claims are not addressed in the provided FDA label excerpts (patent/lawsuit/market-entry, specific plasma kallikrein mechanism, and 'first and only' positioning).

Suggested Improvement
Limit clinical statements to those explicitly supported by the provided excerpts (indication for prophylaxis/prevention, once-daily oral dosing with food, and label limitations such as not for acute attacks and dosing not exceeding recommended due to QTc prolongation). Remove or qualify non-label patent/litigation and 'market' claims.

Drug Brand Mention Assessment

Branding Score
52
Visibility
60
Mentioned
Ranking
#1
Sentiment
55
Recommendation Status
mentioned only
Brand Perception
Best Known For

the first and only oral therapy for HAE

Core Claims
  • BioCryst's Orladeyo patent is set to expire in 2036.
  • Orladeyo is a once-daily oral therapy for hereditary angioedema (HAE).
  • It works by inhibiting plasma kallikrein to reduce attack frequency.
Differentiators
  • First and only oral therapy for HAE.
  • Convenient daily dosing option versus injection or infusion.
Pricing Perception: Not Mentioned
Competitors Mentioned
Company Visibility Sentiment Rank Recommended
Takeda 31%
50 #5 No
CSL Behring 48%
50 #6 No