Details for Patent: 10,888,544

Which drugs does patent 10,888,544 protect, and when does it expire?

Patent 10,888,544 protects CERDELGA and is included in one NDA.

This patent has sixteen patent family members in thirteen countries.

Summary for Patent: 10,888,544

Title:	Methods for treating Gaucher disease
Abstract:	Methods for treating Gaucher disease in patients with renal or hepatic impairment.
Inventor(s):	Jing Li, M. Judith PETERSCHMITT, Vanaja KANAMALURU, Jun Chen, Sebastiaan J. M. Gaemers, Dan RUDIN
Assignee:	Genzyme Corp
Application Number:	US16/219,064
Patent Claim Types: see list of patent claims	Use;

Scope and Claim Construction of US Patent 10,888,544 (Eliglustat Dosing for Gaucher Disease With CYP2D6/CYP3A and Organ Impairment)

US 10,888,544 is a method-of-treatment patent focused on tailoring eliglustat dosing in Gaucher disease based on (i) CYP2D6 metabolizer status (extensive), (ii) hepatic impairment severity (mild), or renal impairment severity (moderate or severe), and (iii) concomitant co-administration of strong or moderate CYP3A inhibitors. The patent also hard-locks specific numeric dosing regimens tied to the patient subgroup and to measurement in eliglustat base form, and it anchors the drug species to eliglustat hemitartrate in dependent claims.

At a practical level, the enforceable claim core is narrow: it requires an exact or constrained combination of biomarker phenotype (CYP2D6 extensive), organ impairment category, and CYP3A inhibitor co-therapy, plus dose regimen details (84 mg once daily in the mild hepatic impairment arm; 84 mg twice daily in the renal impairment arm) and the “base form” measurement constraint.

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What does US Patent 10,888,544 claim about eliglustat dosing for Gaucher disease?

Direct answer: The independent claim (claim 1) requires treating Gaucher disease by administering an adjusted effective amount of eliglustat to a CYP2D6 extensive metabolizer with mild hepatic impairment who is concurrently taking a strong or moderate CYP3A inhibitor.

Independent claim 1: required patient and treatment conditions

Claim 1 elements (all must be met):

1. Indication and action: “method of treating Gaucher disease” by administering eliglustat (or a pharmaceutically acceptable salt).
2. Patient genotype/phenotype: patient is an extensive CYP2D6 metabolizer.
3. Hepatic impairment: patient has mild hepatic impairment.
4. Drug-drug interaction condition: patient is concurrently taking a drug that is strong or moderate CYP3A inhibitor.
5. Dose concept: the administered amount is an “adjusted effective amount” (not specified numerically in claim 1).

Scope implications

• The claim does not read on CYP2D6 intermediate or poor metabolizers.
• The claim does not read on moderate or severe hepatic impairment.
• The claim does not read on patients not taking a strong/moderate CYP3A inhibitor.
• “Concurrently taking” implies contemporaneous exposure, which in enforcement typically translates to co-administration during the period eliglustat is taken.

Dependent claims 2–3: dosing regimen and salt

Claim 2 adds:

• “adjusted effective amount” is a once daily dose of 84 mg of eliglustat (or acceptable salt), measured in base form.

Claim 3 adds:

• the drug species is eliglustat hemitartrate.

Scope implications

• Claims 2 and 3 lock down the numeric regimen: 84 mg once daily for the mild hepatic impairment + extensive CYP2D6 + strong/moderate CYP3A inhibitor subgroup.
• “Measured in base form” is a dosing-chemistry constraint that can matter for infringement if a challenger uses a label different salt amount or different conversion.
• If an accused product uses a different salt or provides 84 mg base equivalent but not as hemitartrate, claim 3 might not be met, but claim 2 may still be met if the “eliglustat or pharmaceutically acceptable salt” is used and dose equivalence is met.

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What does US 10,888,544 cover for renal impairment patients on CYP2D6 extensive phenotype?

Direct answer: Claims 4–6 cover Gaucher treatment with eliglustat in CYP2D6 extensive metabolizers with moderate or severe renal impairment, using a 84 mg twice daily regimen measured in base form, with dependent anchoring to eliglustat hemitartrate.

Claim 4: renal impairment version

Claim 4 elements:

1. Treat Gaucher disease.
2. Administer eliglustat (or acceptable salt).
3. Patient is an extensive CYP2D6 metabolizer.
4. Patient has moderate or severe renal impairment.
5. Administer an effective amount (not numerically defined in the independent claim text provided).

Scope implications

• Unlike claim 1, claim 4 as provided does not require concurrent CYP3A inhibitor use.
• The independent “effective amount” is broader than claim 5 once the regimen is specified.

Claim 5: dose regimen hard constraint

Claim 5 specifies:

• Effective amount is twice daily dose of 84 mg of eliglustat (or acceptable salt),
• measured in base form.

Claim 6: salt

• eliglustat is eliglustat hemitartrate.

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What is the “combination with CYP3A inhibitor” claim scope in US 10,888,544?

Direct answer: Claims 7–9 are another method form that expressly recites treating Gaucher disease by giving an adjusted effective dose of eliglustat in a patient with:

• CYP2D6 extensive metabolizer
• mild hepatic impairment
• concurrent strong/moderate CYP3A inhibitor and then locks to 84 mg once daily (base form) and eliglustat hemitartrate in dependent form.

Claim 7: combination wording

As provided, claim 7 states:

• “administering an adjusted effective dose of eliglustat… in combination with a strong or moderate CYP3A inhibitor,”
• where the patient is CYP2D6 extensive and has mild hepatic impairment.

Scope implications

• Claim 7 likely overlaps heavily with claim 1 but is drafted as a “combination” method. In practice, claim 7 can be used to argue infringement even if a defendant argues that “concurrently taking” in claim 1 is not satisfied, depending on how “in combination with” is construed.
• It still requires mild hepatic impairment and the CYP2D6 extensive phenotype.

Claims 8–9: dose and salt

• Claim 8 sets dose to 84 mg once daily measured in base form.
• Claim 9 specifies eliglustat hemitartrate.

Practical overlap analysis

• Claims 1–3 and claims 7–9 map to the same patient/dosing core. The main difference is drafting structure: one is “wherein said patient is concurrently taking,” the other is “in combination with.”

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How narrow are the claims, and what are the enforceable boundaries?

Direct answer: The enforceable boundary is a three-factor intersection: (CYP2D6 extensive) × (mild hepatic impairment or moderate/severe renal impairment) × (CYP3A strong/moderate inhibition condition in the mild hepatic branch), plus exact dose regimens (84 mg once daily in the hepatic+mild+CYP3A inhibitor branch; 84 mg twice daily in the renal impairment branch) and, for the narrower dependent claims, eliglustat hemitartrate.

Enforceability map by claim cluster

Claim cluster	Required phenotype	Organ impairment	CYP3A inhibitor requirement	Dose regimen requirement	Salt lock
Claims 1, 2, 3	Extensive CYP2D6	Mild hepatic impairment	Yes, strong/moderate CYP3A inhibitor	84 mg once daily (base form)	Claim 3: hemitartrate
Claims 4, 5, 6	Extensive CYP2D6	Moderate or severe renal impairment	Not required (as provided)	84 mg twice daily (base form)	Claim 6: hemitartrate
Claims 7, 8, 9	Extensive CYP2D6	Mild hepatic impairment	Yes, strong/moderate CYP3A inhibitor	84 mg once daily (base form)	Claim 9: hemitartrate

Key boundaries likely to matter in litigation

1. CYP2D6 extensive requirement: Patients must be “extensive metabolizers,” typically determined by genotype or phenotyping.
2. Impairment category: “mild hepatic impairment” vs “moderate or severe renal impairment” are discrete categories. If a patient is reclassified (for example, renal impairment severity differs), the claim may fail.
3. CYP3A inhibitor severity: “strong or moderate CYP3A inhibitor” is a category that depends on regulator/label listings or pharmacology classification.
4. “Base form” measurement: Challenges could focus on whether the asserted dose conversion matches base amount.
5. Salt identity (dependent claims): hemitartrate is specified only in dependent claims; independent claims cover “eliglustat, or pharmaceutically acceptable salt” as provided.

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What is the likely patent landscape around US 10,888,544 (method-of-use and dosing adjustments)?

Given the claims’ subject matter, the surrounding patent landscape for eliglustat typically clusters into:

• CYP2D6 phenotype-based dosing (extensive/intermediate/poor)
• CYP3A inhibitor co-therapy adjustments
• Hepatic impairment dosing adjustments
• Renal impairment dosing adjustments
• Salt form and formulation patents (often separate families)
• Method-of-treatment claims (Gaucher disease)

US 10,888,544 is specifically a dosing-adjustment method-of-treatment family member that ties those elements together, which often positions it against generic or biosimilar product developers seeking to market eliglustat under FDA dosage instructions. For enforcement, this type of claim is designed to reach physicians and distribution channels because the “method” requires patient conditions and a dosing regimen.

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How does US 10,888,544 compare with typical eliglustat labeling dose regimes?

Direct answer: The claim language tracks a label-style logic: eliglustat dosing differs by CYP metabolism phenotype and by CYP3A inhibitor exposure, and it further adjusts by hepatic or renal impairment.

Claim-dosing logic expressed in labeling terms

• For extensive CYP2D6 metabolizers with mild hepatic impairment, concurrent use of strong/moderate CYP3A inhibitors triggers a dose adjustment to 84 mg once daily (base form).
• For extensive CYP2D6 metabolizers with moderate or severe renal impairment, eliglustat dosing is set to 84 mg twice daily (base form).
• Dependent claims fix salt as eliglustat hemitartrate.

This pattern is consistent with how exclusivity and risk are often managed in eliglustat’s post-approval safety communications and dosing instructions.

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What generic entry risks exist if a challenger plans to market eliglustat with different dosing?

Direct answer: The highest infringement risk for this patent arises when a challenger’s proposed dosing instructions include exactly the same constrained regimens for the same patient subgroups and when prescribing practices follow those instructions.

Scenario analysis by claim cluster

1. Hepatic+mild+CYP3A inhibitor scenario
   • If a proposed label instructs dosing that results in 84 mg once daily (base form) for extensive CYP2D6 + mild hepatic impairment patients taking strong/moderate CYP3A inhibitors, the claim 2/3 or 8/9 pathways are highly exposed.
2. Renal impairment scenario
   • If a proposed label supports 84 mg twice daily (base form) for extensive CYP2D6 with moderate/severe renal impairment, claim 5/6 exposure is higher.
3. Labeling deviations
   • If the challenger uses a different regimen, provides contraindication language that blocks the regulated subgroup, or instructs clinicians to avoid strong/moderate CYP3A inhibitors altogether (where the patent requires co-therapy), the probability of meeting the claim elements decreases.

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How would Paragraph IV and FDA pathway strategies likely intersect with this patent type?

Direct answer: For method-of-use patents tied to labeling and prescribing, Paragraph IV challenges typically target whether the accused drug label infringes or would induce infringement. This patent’s element structure (phenotype + organ impairment + co-administered inhibitor class + exact dosing regimen + base-form measure) is well-suited for claim charts that map label instructions to patient criteria.

Claim-chart hooks for a Paragraph IV case

• Is the proposed FDA-approved labeling for the ANDA/BLA aligned with the “adjusted effective amount” and numeric dose in the constrained subgroup?
• Does the label instruct dosing for patients categorized as extensive CYP2D6 metabolizers with mild hepatic impairment on strong/moderate CYP3A inhibitors?
• Does it require dose measured in base form (usually not how labels are written), or does it implicitly match dose equivalence?

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What patent strength factors apply to US 10,888,544 based on claim breadth?

Direct answer: Strength is driven by how many real-world patients match the intersection of conditions, and by how tightly the claim restricts dose and salt.

Pro-strength characteristics

• Numeric dose regimen constraints (84 mg once daily / twice daily) reduce ambiguity in “adjusted effective amount.”
• “Extensive CYP2D6 metabolizer” and impairment categories narrow a defined population.
• Dependent salt locks (hemitartrate) provide a second layer of specificity.

Potential weakness characteristics

• Narrow patient subgroup reduces coverage if competitors avoid the regulated patient class through label carve-outs.
• “Strong or moderate CYP3A inhibitor” depends on classification and may be contested.
• “Concurrently” and “mild hepatic impairment” may invite disputes over timing and clinical characterization, but the claim is still anchored to specific categories.

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Which litigation and settlements are implicated by this claim set?

No litigation docket details, settlements, or infringement findings can be stated from the provided information alone.

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What is the likely commercial relevance of US 10,888,544 for eliglustat competition?

Direct answer: Commercial exposure is concentrated in the subset of Gaucher disease patients who are extensive CYP2D6 metabolizers and fall into mild hepatic impairment and/or moderate/severe renal impairment and, in the hepatic branch, are exposed to strong/moderate CYP3A inhibitors. These are the prescribing conditions most likely to be reflected in dosing algorithms and label instructions.

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Key Takeaways

• Core claim theme: Adjust eliglustat dosing for Gaucher disease based on CYP2D6 extensive status, hepatic or renal impairment category, and CYP3A inhibitor co-therapy.
• Most enforceable sub-population: Extensive CYP2D6 + mild hepatic impairment + concurrent strong/moderate CYP3A inhibitor.
• Dose regimens locked in dependent claims: 84 mg once daily (base form) for the hepatic branch and 84 mg twice daily (base form) for the renal branch.
• Salt specificity: Dependent claims anchor to eliglustat hemitartrate.
• Generic/label risk: Any competitor whose approved labeling or induced prescribing results in these exact regimens for matching patients increases infringement exposure.

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FAQs

1. Does US 10,888,544 cover CYP2D6 intermediate or poor metabolizers?
No, the provided claims require extensive CYP2D6 metabolizer status.

2. Is CYP3A inhibitor co-therapy required in the renal impairment claims?
As provided, the renal impairment independent claim (claim 4) does not require a CYP3A inhibitor condition.

3. What dosing regimen is claimed for extensive CYP2D6 patients with mild hepatic impairment on strong/moderate CYP3A inhibitors?
84 mg once daily (eliglustat or salt, measured in base form), with dependent claims specifying hemitartrate.

4. What dosing regimen is claimed for extensive CYP2D6 patients with moderate or severe renal impairment?
84 mg twice daily (base form), with dependent claims specifying hemitartrate.

5. What does “measured in base form” change for potential infringement?
It makes the dose equivalence tied to eliglustat free base amount, which can affect whether a disputed salt amount maps to the claimed 84 mg base regimen.

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References

None provided in the prompt.

Drugs Protected by US Patent 10,888,544

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014	AB	RX	Yes	Yes						LONG-TERM TREATMENT OF ADULTS WITH GAUCHER DISEASE TYPE 1 WHO ARE CYP2D6 EXTENSIVE METABOLIZERS WITH MODERATE TO SEVERE RENAL IMPAIRMENT
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494-001	Aug 19, 2014	AB	RX	Yes	Yes						LONG-TERM TREATMENT OF ADULTS WITH GAUCHER DISEASE TYPE 1 WHO ARE CYP2D6 EXTENSIVE METABOLIZERS WITH MILD HEPATIC IMPAIRMENT AND ARE CONCURRENTLY TAKING A STRONG OR MODERATE CYP3A INHIBITOR

International Family Members for US Patent 10,888,544

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2018386182
Brazil	112020011056
Canada	3083663