United States Drug Patent 11,857,542: Ubrogepant Renal-Impairment Claims, Exclusivity and Patent Landscape

United States Patent No. 11,857,542 protects a narrow method of using 50 mg ubrogepant for acute migraine treatment in patients with severe renal impairment. The patent is directed to a dosing population defined by a Cockcroft-Gault creatinine clearance of 15-29 mL/min. Its commercial value is concentrated in the severe-renal-impairment segment of the Ubrelvy label rather than in the broader migraine market.

The patent creates a potential method-of-use barrier for a generic ubrogepant product that seeks approval with labeling covering 50 mg dosing in patients with severe renal impairment. It does not broadly protect ubrogepant, the Ubrelvy tablet formulation, or every migraine treatment regimen.

What does United States Patent 11,857,542 cover?

US 11,857,542 is titled “Methods of treating migraine in patients with renal impairment.” The patent was issued on January 2, 2024, to Allergan Pharmaceuticals International Limited, an AbbVie group company.[1]

The independent claim requires all of the following:

Claim element	Scope
Disease	Acute migraine with or without aura
Patient population	Severe renal impairment
Renal measurement	Estimated creatinine clearance calculated by the Cockcroft-Gault equation
Renal range	15-29 mL/min
Active ingredient	Ubrogepant
Route	Oral administration
Dose	50 mg
Outcome	Migraine is safely and effectively treated

The claim is cumulative. A method that omits any required element falls outside literal claim 1. For example, treatment of a patient with a creatinine clearance of 30 mL/min or higher does not satisfy the express 15-29 mL/min limitation.

The claim does not require a particular tablet excipient, manufacturing process, brand, treatment setting, sex, age, migraine frequency, or genetic profile.

How do claims 2, 3 and 4 expand the patent scope?

Claims 2 through 4 add narrower use scenarios.

What does claim 2 protect?

Claim 2 covers the method in claim 1 when the patient receives a second 50 mg dose at least two hours after the first dose.

The claimed total regimen is therefore 100 mg, administered as two 50 mg doses. The claim does not require the second dose to be given on the same calendar day, because claim 2 states only “at least 2 hours.”

What does claim 3 protect?

Claim 3 narrows claim 2 by requiring the second dose to be administered between two and 24 hours after the initial dose.

This creates a specific redosing window:

Initial dose: 50 mg orally
Second dose: 50 mg orally
Minimum interval: two hours
Maximum interval: 24 hours

A second dose given after more than 24 hours would not satisfy claim 3, although it could still fall within claim 2 if administered at least two hours after the initial dose.

What does claim 4 protect?

Claim 4 requires the patient to achieve freedom from at least one migraine symptom within two hours after administration.

The claim does not require complete migraine freedom. It can be satisfied by relief from one symptom, depending on how the patent and clinical evidence define the relevant migraine symptom. Possible symptoms include headache pain, nausea, photophobia, phonophobia or other clinically recognized migraine manifestations.

Claim 4 has narrower proof requirements than claim 1 because infringement analysis would need evidence concerning the patient’s response within the two-hour period.

How strong is the patent estate for severe renal impairment dosing?

The estate is strong against an exact-label copy of the claimed regimen but narrow against alternative dosing strategies.

Principal strengths

The renal impairment range is specific and clinically identifiable.
The claim uses the Cockcroft-Gault equation, providing a defined measurement method.
The claimed dose matches the reduced-dose approach in the Ubrelvy prescribing information for severe renal impairment.[2]
The claims cover both initial treatment and a commercially relevant second-dose regimen.
A generic applicant that includes the same severe-renal-impairment dosing instructions could face a direct method-of-use challenge.

Principal limitations

The claims do not cover all renal impairment categories.
The claims do not cover patients with creatinine clearance below 15 mL/min.
The claims do not cover intravenous, intranasal or other non-oral delivery.
The claims do not cover doses other than 50 mg.
The patent does not claim the ubrogepant molecule itself.
The patent does not claim the tablet composition or manufacturing process.
The “safely and effectively treated” language may create an evidentiary issue if treated as a result limitation.
Claim 4 requires a clinical response within two hours and is narrower than the core dosing claim.

The patent’s practical strength depends on whether the alleged infringer’s approved label, physician instructions or marketing materials direct the claimed use. A generic product could attempt to avoid infringement through a restricted label that omits the severe-renal-impairment indication, subject to FDA labeling rules and the scope of any other applicable Ubrelvy patents.

What is the Orange Book status of US 11,857,542?

US 11,857,542 is associated with the Ubrelvy drug product, whose active ingredient is ubrogepant. The patent is a method-of-use patent rather than a composition-of-matter patent.

The relevant regulatory framework is:

The New Drug Application holder lists qualifying patents with FDA under 21 C.F.R. § 314.53.
A generic applicant must address listed patents in an ANDA certification.
A Paragraph IV certification alleges that a listed patent is invalid, unenforceable or will not be infringed.
A section viii statement may seek approval without the patented method if the proposed label omits the protected use.
A timely patent-infringement action can trigger a statutory 30-month stay under 21 U.S.C. § 355(j)(5)(B)(iii).

The Orange Book listing does not determine validity. It gives the patent procedural significance in the ANDA pathway.

The key commercial question is whether the patent remains listed when an ANDA applicant files for ubrogepant tablets and whether the proposed label contains the severe-renal-impairment dosing language. A listing that covers only a narrow use may still delay approval if the generic applicant challenges it through Paragraph IV.

When does US 11,857,542 lose exclusivity?

US 11,857,542 has a nominal patent term extending into 2040 based on its filing and priority framework. The exact expiration date must be determined from the patent’s term calculation, including any patent-term adjustment, terminal disclaimer or other USPTO record affecting the patent.

A practical exclusivity timeline is:

Event	Timing
Ubrogepant FDA approval	December 2019
US 11,857,542 issue	January 2, 2024
Patent protection for the claimed renal-impairment method	Expected to extend into approximately 2040
ANDA Paragraph IV filing	Potentially before patent expiration
30-month stay	Potentially available if statutory conditions are met
Generic launch	Dependent on patent litigation, settlement terms, court outcome and other listed patents

The patent’s late issuance does not create a fresh 20-year term beginning in 2024. Patent term generally runs from the relevant nonprovisional filing date, subject to statutory adjustments.

FDA approval exclusivity is separate from patent exclusivity. Ubrelvy’s original approval did not give the sponsor biologic-style exclusivity, and the product is not a biologic. The commercial barrier is therefore primarily patent-based, combined with regulatory approval requirements and potential litigation.

What Paragraph IV challenges could affect Ubrelvy?

A generic applicant seeking approval for ubrogepant tablets could use one of three broad strategies.

Paragraph IV challenge

The applicant could certify that US 11,857,542 is invalid, unenforceable or not infringed. Potential arguments could include:

Lack of anticipation or obviousness based on renal dosing information available before the relevant filing date.
Lack of written description or enablement for the full patient and dosing population.
Indefiniteness in the measurement or outcome limitations.
Non-infringement based on differences in the proposed label or dosing instructions.
Failure to establish that the claimed regimen is patentably distinct from known ubrogepant dosing.

The renal-range limitation may make anticipation more difficult if prior references disclose renal impairment generally but do not disclose the 15-29 mL/min range, Cockcroft-Gault calculation and 50 mg dose in combination.

Section viii carve-out

The applicant could seek approval for migraine treatment while omitting the severe-renal-impairment use. This strategy is commercially more useful if the protected population represents a small share of prescriptions and FDA permits an accurate label carve-out.

A carve-out does not eliminate all risk. Physician prescribing, promotional activity, labeling language and the scope of other patents can affect an induced-infringement analysis.

Delayed filing or settlement

The applicant could defer a challenge until the patent approaches expiration or negotiate a settlement allowing a defined launch date. A settlement could include a license, a no-challenge provision, or an agreed entry date, subject to antitrust review and applicable FTC or DOJ scrutiny.

No settlement terms should be inferred from the patent’s existence or Orange Book listing alone.

What other patents protect Ubrelvy and ubrogepant?

The broader ubrogepant patent estate is expected to include multiple categories.

Patent category	Commercial subject	Relevance to US 11,857,542
Composition of matter	Ubrogepant chemical compound and related CGRP receptor antagonists	Broadest product protection, but separate from renal dosing
Solid-state or salt forms	Crystalline forms, polymorphs or pharmaceutical forms	Can protect the marketed active ingredient or intermediate
Formulation	Tablets, excipients, dissolution and stability characteristics	Relevant to the finished dosage form
Manufacturing	Synthetic routes, intermediates and process controls	Can constrain supply-chain alternatives
Method of treatment	Acute migraine treatment and dosing regimens	Includes the renal-impairment claims in US 11,857,542
Combination use	Ubrogepant with other migraine therapies	May create additional method-of-use barriers

Public patent databases and FDA Orange Book records should be reviewed as a portfolio rather than as a single-patent question. A generic applicant may avoid one patent but still face composition, formulation or process patents.

The principal distinction is that US 11,857,542 does not prevent a competitor from making or selling ubrogepant in the abstract. It targets a defined clinical use.

What formulations are protected by US 11,857,542?

The patent claims oral administration of 50 mg ubrogepant but do not expressly require a particular formulation.

The claims could therefore reach:

Immediate-release tablets
Other orally administered solid dosage forms
Oral formulations delivering 50 mg ubrogepant

The claims do not expressly require:

A particular inactive ingredient
A specific dissolution profile
A particular tablet coating
A specific manufacturing process
A branded Ubrelvy tablet

A separate formulation patent would be needed to protect those technical features. Formulation patents can remain commercially relevant after a composition patent expires, particularly when the approved product depends on a particular release profile or stability profile.

Does biosimilar law apply to ubrogepant?

No. Ubrogepant is a small-molecule drug, not a biologic. Biosimilar approval under the Biologics Price Competition and Innovation Act does not apply.

A competing ubrogepant product would generally use the ANDA pathway under section 505(j) if it can demonstrate pharmaceutical equivalence and bioequivalence. Patent challenges would therefore proceed through Orange Book certifications, including Paragraph IV or section viii mechanisms.[3]

The relevant competitive risks are generic substitution, label carve-outs, authorized generic supply and potential branded-generic settlements, not biosimilar interchangeability.

Which companies control or challenge the ubrogepant market?

AbbVie controls Ubrelvy through its ownership of Allergan’s pharmaceutical assets. Allergan acquired global rights to ubrogepant and related CGRP receptor antagonist assets from Merck in 2015.[4]

The competitive landscape includes:

AbbVie’s Ubrelvy, an oral CGRP receptor antagonist
Rimegepant, marketed as Nurtec ODT by Pfizer
Zavegepant, marketed as Zavz pret? by Pfizer as a nasal CGRP antagonist
Triptans, including sumatriptan and rizatriptan
Ditan and other acute migraine products
Future generic ubrogepant tablets

Rimegepant and zavegepant do not directly practice the ubrogepant claims because they use different active ingredients. They compete commercially but do not create direct infringement exposure under US 11,857,542.

What litigation and settlement risks affect this patent?

The principal litigation risk will arise when an ANDA applicant makes a Paragraph IV certification against the patent. The likely dispute would focus on whether the generic label directs treatment of patients with creatinine clearance of 15-29 mL/min using 50 mg ubrogepant.

Potential causes of action include:

Direct infringement under 35 U.S.C. § 271(e)(2), based on the ANDA filing
Induced infringement based on proposed labeling or promotional materials
Declaratory judgment claims
Invalidity counterclaims
Patent-term and Orange Book listing disputes

The most important factual issue will be the proposed generic label. A label that reproduces the severe-renal-impairment instruction creates greater infringement exposure than a label limited to non-renal-impaired patients.

A settlement could permit entry before the patent’s nominal expiration date. The terms would determine the actual market-entry date, whether an authorized generic is involved and whether the entrant can market the protected indication.

How does US 11,857,542 compare with broad ubrogepant patents?

US 11,857,542 is narrower in claim breadth but potentially later in expiration than foundational compound patents.

Issue	US 11,857,542	Composition patent
Protected subject	Severe renal impairment dosing	Ubrogepant molecule or chemical class
Infringement trigger	Practicing the claimed treatment method	Making, using or selling the claimed compound
Patient limitation	Yes	Usually no
Dose limitation	50 mg	Usually no
Formulation limitation	No express limitation	Usually no
Commercial breadth	Narrow	Broad
Generic design-around potential	Higher	Lower if valid and unexpired
Clinical-label significance	High for severe renal impairment	Product-wide

A generic may be unable to launch commercially even after avoiding US 11,857,542 if an earlier composition or formulation patent remains enforceable. Conversely, the renal-impairment patent may delay approval for the full label even if the core compound patent has expired.

What are the generic launch scenarios for ubrogepant?

Scenario 1: Full-label Paragraph IV challenge

The generic applicant challenges US 11,857,542 and other listed patents. AbbVie sues within the statutory period, creating a potential 30-month stay. Launch then depends on settlement or litigation outcome.

Scenario 2: Skinny-label launch

The generic omits the severe-renal-impairment indication and seeks approval for other acute migraine uses. This can reduce method-of-use exposure but may leave the applicant exposed if its label or commercial conduct encourages the patented use.

Scenario 3: Post-expiration launch

The generic waits for expiration of the relevant patents. This reduces litigation risk but sacrifices first-filer or early-entry advantages.

Scenario 4: Licensed launch

The applicant reaches a license or settlement with AbbVie. The launch date, authorized-generic terms and scope of the licensed indication become the principal commercial variables.

Key Takeaways

US 11,857,542 is a narrow method-of-use patent for 50 mg oral ubrogepant in severe renal impairment.
The protected renal range is creatinine clearance of 15-29 mL/min using the Cockcroft-Gault equation.
Claim 2 covers a second 50 mg dose at least two hours later.
Claim 3 limits the second dose to the two-to-24-hour period.
Claim 4 requires freedom from at least one migraine symptom within two hours.
The patent does not broadly cover ubrogepant, Ubrelvy tablets or all migraine treatment.
Its commercial importance is tied to the FDA-approved severe-renal-impairment dosing language.
Generic applicants may use Paragraph IV certification, a section viii carve-out, settlement or delayed entry.
Ubrogepant is a small molecule, so biosimilar law does not apply.
The patent’s nominal term reaches approximately 2040, subject to the USPTO term calculation.
The patent should be assessed with Ubrelvy composition, formulation and process patents before estimating generic-entry timing.

FAQs About US 11,857,542 and Ubrogepant Patent Risk

Can a generic sell ubrogepant without infringing US 11,857,542?

Potentially. A product that omits the patented severe-renal-impairment use from its label may have a section viii pathway, but other patents and inducement theories remain relevant.

Does the patent cover patients with creatinine clearance below 15 mL/min?

No. The express claim range is 15-29 mL/min. Patients below that range are outside the literal renal-function limitation.

Does a 100 mg single dose fall within the patent?

No. The claims require an initial oral dose of 50 mg. Claims 2 and 3 require a second 50 mg dose, not a single 100 mg dose.

Can a physician infringe the patent by prescribing Ubrelvy?

A physician’s prescription may constitute method infringement if it practices every claim element. Generic-company exposure generally centers on the ANDA filing, label, inducement and commercial conduct.

Is US 11,857,542 a formulation patent?

No. It is a method-of-treatment patent. It claims a patient population, dosing regimen and therapeutic outcome rather than tablet composition or manufacturing technology.

References

United States Patent and Trademark Office. (2024). U.S. Patent No. 11,857,542, Methods of treating migraine in patients with renal impairment.
U.S. Food and Drug Administration. (2024). Ubrelvy (ubrogepant) prescribing information.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
Allergan plc. (2015). Allergan acquires global rights to Merck’s investigational oral CGRP receptor antagonists.
21 U.S.C. § 355.
35 U.S.C. §§ 271(e)(2), 281-285.
21 C.F.R. § 314.53.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Abbvie	UBRELVY	ubrogepant	TABLET;ORAL	211765-001	Dec 23, 2019		RX	Yes	No	11,857,542	⤷ Start Trial				ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN A PATIENT WITH SEVERE RENAL IMPAIRMENT	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Patented / Exclusive Use	>Submissiondate

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2015214502	⤷ Start Trial
Australia	2019226239	⤷ Start Trial
Australia	2021245229	⤷ Start Trial
Australia	2021409718	⤷ Start Trial
Australia	2023258317	⤷ Start Trial
Australia	2025220825	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 11,857,542

Which drugs does patent 11,857,542 protect, and when does it expire?

Summary for Patent: 11,857,542