United States Drug Patent 11,083,724: Claim Scope, Rimegepant ODT Protection, Expiration, and Patent Landscape

U.S. Patent No. 11,083,724 protects oral solid molded fast-dispersing dosage forms containing a CGRP receptor antagonist, with narrower claims directed to 75-mg rimegepant, rimegepant hemisulfate sesquihydrate, fish gelatin, mannitol or another filler, rapid saliva dispersion, and a specified pharmacokinetic profile. The patent’s practical commercial relevance is concentrated in rimegepant orally disintegrating tablets, including the formulation used for Nurtec ODT.

The broadest independent composition claim is not limited to rimegepant. It covers a therapeutically effective CGRP antagonist in an oral solid molded fast-dispersing form. Claims 11-20 narrow the estate to rimegepant, including a 75-mg dosage and a specific rimegepant salt. The patent is therefore both a platform formulation patent and a product-specific rimegepant patent.

Based on the patent’s earliest claimed priority framework, the ordinary statutory expiration date is approximately September 2039, subject to any applicable patent-term adjustment or regulatory extension reflected in official records. The patent should be analyzed with other rimegepant patents, FDA Orange Book listings, and any Paragraph IV litigation rather than as a standalone barrier.

What does U.S. Patent 11,083,724 protect?

U.S. Patent 11,083,724 protects molded, fast-dispersing oral solid dosage forms containing CGRP receptor antagonists. Its claims combine four principal elements:

A CGRP receptor antagonist or pharmaceutically acceptable salt.
A pharmaceutically acceptable carrier.
An oral solid molded fast-dispersing dosage form.
In narrower claims, defined excipients, dosage strength, salt form, disintegration performance, and pharmacokinetic exposure.

The claims identify olcegepant, telcagepant, ubrogepant, atogepant, and rimegepant as covered antagonists. The independent claims do not require every listed excipient. Gelatin, mannitol, fish gelatin, flavorant content, saliva dispersion, and the AUC limitation appear in dependent claims.

The patent’s commercial center of gravity is claims 11-20 because they specifically address rimegepant. Claims 1-10 have broader theoretical reach but may face greater validity and infringement disputes because they cover multiple antagonists and a broad class of molded fast-dispersing products.

How are the claims organized?

Composition claims 1-7

Claims 1-7 cover the general formulation platform.

Claim	Principal limitation	Commercial significance
1	CGRP antagonist, carrier, oral solid molded fast-dispersing dosage form	Broad platform composition claim
2	Antagonist selected from five named CGRP antagonists	Identifies the intended drug class and products
3	Gelatin carrier	Narrows the carrier system
4	Mannitol filler	Narrows the formulation excipient
5	70-80 wt% antagonist, 10-20 wt% fish gelatin, 10-20 wt% filler, 0.1-5 wt% flavorant	Important composition-range claim
6	Dispersion or disintegration within 1-60, 1-30, 1-10, or 2-8 seconds	Performance-based limitation
7	Fluid includes saliva	Targets orally disintegrating use

Claim 5 is especially relevant to manufacturing and freedom-to-operate analysis. A competing formulation outside one or more stated weight ranges may avoid literal infringement of that dependent claim, although it could remain within claim 1 or another asserted claim.

Method-of-treatment claims 8-10

Claims 8-10 cover treatment of migraine by administering the claimed fast-dispersing formulation.

Claim 8 requires:

a patient in need of migraine treatment;
a therapeutically effective CGRP antagonist;
an oral solid molded fast-dispersing dosage form.

Claim 9 identifies the five named antagonists. Claim 10 imports the composition ranges in claim 5.

These claims create a separate infringement pathway from the composition claims. A generic manufacturer may avoid direct method-of-treatment infringement arguments by labeling strategies, but a product sold with a use directed to acute migraine treatment can create substantial induced-infringement exposure under the Hatch-Waxman framework if the patented method is included in, or encouraged by, the proposed labeling.[2]

Rimegepant claims 11-20

Claims 11-20 are the most product-specific claims.

Claim	Principal limitation
11	Rimegepant composition in an oral solid molded fast-dispersing form
12	About 75 mg of rimegepant or salt
13	Rimegepant hemisulfate sesquihydrate
14	Tablet form
15	AUC0-t of approximately 4,000-6,250 hr*ng/mL
16	70-80 wt% rimegepant hemisulfate sesquihydrate, 10-20 wt% fish gelatin, 10-20 wt% filler, 0.1-5 wt% flavorant
17	Gelatin carrier
18	Mannitol filler
19	Dispersion or disintegration within specified time intervals
20	Saliva as the contacting fluid

Claim 11 is broader than claims 12-20 because it does not require a 75-mg strength, a particular salt, a tablet, a particular composition range, or the AUC limitation. A product can therefore infringe claim 11 without falling within claim 16.

What is the scope of the fast-dispersing dosage-form limitation?

The phrase “oral solid molded fast-dispersing dosage form” is a central claim limitation. It distinguishes the claimed products from ordinary compressed immediate-release tablets and conventional swallowed capsules.

The limitation likely requires a product with the following characteristics:

a solid dosage form;
formation by a molding or equivalent molded-dosage process;
oral administration;
rapid dispersion or disintegration after contact with fluid;
a formulation suitable for use in the mouth, including saliva.

A conventional compressed rimegepant tablet would face a stronger non-infringement position if it is not molded and does not satisfy the fast-dispersing limitation. A conventional oral tablet that rapidly disintegrates is not automatically outside the claims, because claims 6, 19, and 20 focus on dispersion performance while claims 1 and 11 separately require a molded dosage form.

The prosecution history and specification would be important in determining whether “molded” is limited to a particular lyophilization or freeze-drying process, such as a Zydis-type process, or includes broader molding technologies. The claim language alone does not establish a single exclusive manufacturing method.

What formulations are protected by U.S. Patent 11,083,724?

The most specifically protected formulation is a rimegepant fast-dispersing tablet containing:

approximately 75 mg of rimegepant;
rimegepant hemisulfate sesquihydrate;
fish gelatin;
mannitol or another filler;
flavorant;
rapid dispersion or disintegration in saliva.

Claim 16 defines the principal formulation window:

Component	Claimed range
Rimegepant hemisulfate sesquihydrate	About 70-80 wt%
Fish gelatin	About 10-20 wt%
Filler	About 10-20 wt%
Flavorant	0.1-5.0 wt%

The ranges overlap numerically, so the specification must be examined for whether the percentages are intended to be cumulative, whether they are approximate, and how the balance of the formulation is treated. A formulation containing different excipients may avoid claim 16 while remaining exposed under claim 11 or claim 14 if it still satisfies the broader product limitations.

How strong is the patent estate for rimegepant ODT?

The patent has a layered structure, which is stronger than reliance on a single narrow formulation claim.

Strengths

The principal strengths are:

claim 11 directly targets rimegepant in the fast-dispersing molded dosage form;
claim 12 tracks the commercial 75-mg dosage;
claim 13 identifies the rimegepant hemisulfate sesquihydrate salt;
claim 14 covers tablet presentation;
claims 19 and 20 add rapid dispersion and saliva performance;
claim 16 supplies a detailed excipient and concentration profile;
the claim set includes both composition and method-of-treatment claims.

This structure creates multiple assertion routes. A competing product may avoid the exact fish gelatin and mannitol ranges but still face claims directed to the drug, dosage form, or performance.

Vulnerabilities

The principal vulnerabilities are:

prior art involving molded or rapidly dispersing oral dosage forms;
prior art involving CGRP antagonists in fast-dispersing formulations;
written-description and enablement challenges across five chemically distinct antagonists;
indefiniteness disputes concerning “about,” “fast-dispersing,” and overlapping time intervals;
testing disputes concerning the AUC limitation in claim 15;
non-infringement positions based on compressed rather than molded tablets;
formulation redesign using different excipients or a different rimegepant salt.

Claim 15 is narrower but technically important. Its AUC limitation can create testing disputes because exposure depends on dose, salt form, food conditions, study population, analytical method, and sampling interval. It may also be difficult to establish infringement without controlled comparative pharmacokinetic testing.

When does U.S. Patent 11,083,724 expire?

The patent’s ordinary term is expected to run to approximately September 2039, calculated from its earliest relevant nonprovisional priority framework. The exact effective expiration date should be taken from the USPTO patent record and any applicable patent-term adjustment calculation.[1]

Event	Date or period
Patent grant	2021
Expected ordinary term endpoint	Approximately September 2039
Potential term adjustment	Must be checked in the USPTO patent record
Relevant regulatory exclusivity	Separate from patent expiration
Product-linked Orange Book protection	Must be confirmed against the current FDA listing

Patent expiration does not necessarily equal the end of all rimegepant protection. Other patents may cover the active ingredient, crystalline or salt forms, methods of treatment, formulations, manufacturing processes, or additional indications.

What is the FDA and Orange Book status of this patent?

Nurtec ODT, containing rimegepant sulfate, was approved by the FDA in February 2020 for the acute treatment of migraine in adults. The FDA later expanded the product’s labeling to include preventive treatment of episodic migraine in adults.[3]

The Orange Book may list patents that the approved applicant identifies as claiming the drug substance, drug product, or approved method of use. A patent’s inclusion depends on FDA listing requirements and does not itself establish validity or infringement.[4]

For this patent, the relevant regulatory questions are:

whether U.S. Patent 11,083,724 is listed against the applicable Nurtec ODT strength;
which claims are identified as covering the approved drug product or method of use;
the expiration date recorded by FDA;
whether a generic applicant must make a Paragraph IV certification;
whether any pediatric exclusivity or patent-term adjustment modifies the effective barrier.

An ANDA applicant generally must address listed patents through Paragraph I, II, III, or IV certifications. A Paragraph IV certification alleges that a listed patent is invalid, unenforceable, or will not be infringed. The filing of a qualifying Paragraph IV notice can trigger patent litigation and, if suit is filed within the statutory period, a 30-month stay of approval under the Hatch-Waxman Act.[2]

Which companies are challenging rimegepant exclusivity?

Rimegepant generic competition is expected to come from ANDA applicants rather than biosimilar developers because rimegepant is a small-molecule drug. Public competitive analysis should distinguish among:

ANDA applicants challenging the active-ingredient patents;
ANDA applicants challenging the ODT formulation patents;
applicants seeking a different dosage form;
applicants using Section viii labeling carve-outs;
settlement parties receiving licensed or delayed entry rights.

The patent number alone does not establish that a particular company has filed a Paragraph IV challenge. Company-specific attribution requires a current FDA Orange Book record, Paragraph IV notice, complaint, answer, settlement filing, or court docket.

What patent litigation affects U.S. Patent 11,083,724?

The legal risk should be separated into four categories:

Validity litigation concerning anticipation, obviousness, written description, enablement, or indefiniteness.
Infringement litigation concerning molding, disintegration, salt form, dose, composition ranges, or AUC.
Hatch-Waxman litigation triggered by an ANDA Paragraph IV certification.
Settlement litigation involving delayed entry, licenses, or restrictions on generic labeling.

A patent can be listed in the Orange Book without having been litigated. Conversely, litigation can involve related patents that create the practical market-entry barrier even when this patent is not the only asserted patent.

For a generic rimegepant ODT, the highest-risk infringement questions are likely to be:

whether the dosage form is molded;
whether the product is fast-dispersing in saliva;
whether the formulation uses the claimed rimegepant salt;
whether its composition falls within claim 16;
whether its labeling encourages the patented migraine-treatment method;
whether the product meets the claim 15 AUC range.

What Paragraph IV strategies are available against this patent?

A generic applicant could pursue several positions.

Non-infringement

The applicant could argue that its product:

is a conventional compressed tablet;
is not molded;
does not disperse within the claimed interval;
uses a different rimegepant salt;
does not contain fish gelatin;
does not fall within the claimed weight ranges;
does not achieve the claimed AUC profile;
uses labeling that omits a patented method of use.

Avoiding claim 16 alone would not necessarily avoid claim 11.

Invalidity

Potential invalidity theories include:

anticipation by prior fast-dispersing CGRP antagonist formulations;
obviousness based on known ODT technologies and known rimegepant formulations;
lack of enablement for the full scope of multiple antagonists;
inadequate written description for the genus and species combinations;
indefiniteness of “about,” “fast-dispersing,” or the AUC range.

The strength of these defenses depends on the full specification, prosecution history, cited prior art, and claim construction. The supplied claims do not resolve those issues.

Section viii carve-out

A generic applicant may attempt to omit a patented use from its label if FDA and litigation conditions permit. This strategy is less useful when the dosage form itself is the asserted claim, because a labeling carve-out does not remove composition or product-formulation infringement.

How does this patent compare with competing CGRP products?

Product	Active ingredient	Manufacturer	Dosage form	Relevance to Patent 11,083,724
Nurtec ODT	Rimegepant	Pfizer, following Biohaven acquisition	Oral disintegrating tablet	Direct commercial target
Ubrelvy	Ubrogepant	AbbVie	Conventional oral tablet	Covered by broad named-antagonist claims only if molded fast-dispersing
Qulipta	Atogepant	AbbVie	Conventional oral tablet	Same limitation issue
Reyvow	Lasmiditan	Eli Lilly	Conventional tablet	Outside the named CGRP antagonist claims
Aimovig	Erenumab	Amgen/Novartis	Injectable biologic	No direct formulation overlap
Ajovy	Fremanezumab	Teva	Injectable biologic	No direct formulation overlap
Emgality	Galcanezumab	Eli Lilly	Injectable biologic	No direct formulation overlap

The patent has limited direct reach over conventional ubrogepant or atogepant tablets because the independent claims require an oral solid molded fast-dispersing dosage form. It has no direct biosimilar relevance to injectable CGRP monoclonal antibodies. Its practical competitive effect is concentrated on rimegepant ODT and any competing molded fast-dispersing CGRP antagonist product.

What generic launch scenarios exist for rimegepant ODT?

At-risk launch before patent expiration

A generic company could launch after receiving FDA approval but before patent expiry if it prevails in litigation, obtains a covenant not to sue, or accepts the risk of damages and injunctive relief. This is the highest-risk pathway.

Launch after a Paragraph IV judgment

A finding of invalidity or non-infringement could remove the patent as a barrier. The commercial result would still depend on other listed rimegepant patents.

Licensed or settlement-based entry

A settlement could establish a later agreed entry date, potentially with a license, authorized generic arrangement, or other market-access terms. Settlement terms must be evaluated under antitrust and FTC scrutiny.

Launch after patent expiry

This is the lowest legal-risk pathway for this patent but may not eliminate exposure under related patents.

What manufacturing and intellectual-property barriers remain?

The formulation claims create barriers beyond the active ingredient itself.

A competing manufacturer may need to develop:

a non-molded dosage form;
a different fast-dispersing technology;
a different salt or polymorph;
a gelatin-free carrier system;
a filler system outside the claimed ranges;
a disintegration profile outside the claimed intervals;
a process that avoids protected molding steps.

Design-around analysis must cover both product and process patents. A formulation that avoids this patent may still implicate separate patents covering rimegepant polymorphs, salts, synthesis, crystalline forms, or other dosage forms.

What is the likely revenue exposure from this patent?

The patent’s revenue exposure is tied primarily to Nurtec ODT rather than the entire CGRP market. A generic entry that substitutes for Nurtec ODT could affect:

branded rimegepant tablet volume;
migraine acute-treatment revenue;
episodic migraine prevention revenue;
payer formulary positioning;
pharmacy substitution;
pricing and rebate levels.

The patent does not by itself block competing CGRP products such as Ubrelvy or Qulipta in their conventional tablet forms. It also does not block injectable CGRP antibodies. Its economic value therefore depends on the share of rimegepant demand delivered through the protected molded fast-dispersing form and on the remaining patent and regulatory exclusivity portfolio.

Key Takeaways

U.S. Patent 11,083,724 is a formulation and method-of-treatment patent focused on molded fast-dispersing oral CGRP antagonist products.
Claims 11-20 are the most important for rimegepant because they cover the active ingredient, 75-mg strength, hemisulfate sesquihydrate salt, tablet form, excipient ranges, rapid dispersion, saliva contact, and AUC.
The ordinary patent term is expected to extend to approximately September 2039, subject to the official USPTO term calculation.
The patent is most relevant to Nurtec ODT and has limited direct reach over conventional ubrogepant or atogepant tablets.
Avoiding fish gelatin, mannitol, or claim 16’s weight ranges may not avoid broader claim 11.
A conventional compressed tablet may have a stronger non-infringement position if it does not satisfy the molded fast-dispersing limitation.
Rimegepant is a small molecule, so generic ANDA challenges, not biosimilar applications, are the relevant competitive pathway.
The patent must be assessed with the complete Orange Book and related rimegepant patent portfolio.

FAQs

Does U.S. Patent 11,083,724 cover all rimegepant tablets?

No. The claims require an oral solid molded fast-dispersing dosage form. A conventional swallowed compressed tablet may fall outside the claims, depending on its manufacturing process and performance.

Does avoiding mannitol avoid infringement?

No. Mannitol appears in a dependent claim. A product without mannitol may still fall within broader rimegepant claims or other dependent claims.

Is the 75-mg dose required for every rimegepant claim?

No. The 75-mg limitation appears in claim 12. Claim 11 covers rimegepant in the specified dosage form without expressly requiring 75 mg.

Does the patent cover injectable CGRP antibodies?

No. The listed antagonists and dosage-form limitations do not cover injectable monoclonal antibodies such as erenumab, fremanezumab, or galcanezumab.

Can a generic launch with a different rimegepant salt?

Possibly, but changing the salt does not automatically eliminate infringement. The generic product would need to be evaluated against the broader rimegepant claims, the molded fast-dispersing limitation, and all related patents.

References

United States Patent and Trademark Office. (2021). U.S. Patent No. 11,083,724, pharmaceutical composition and method claims for fast-dispersing CGRP receptor antagonist dosage forms.
21 U.S.C. §§ 355, 271(e), 505. (2024). Federal Food, Drug, and Cosmetic Act and Hatch-Waxman patent provisions.
U.S. Food and Drug Administration. (2020). Nurtec ODT prescribing information: Rimegepant sulfate orally disintegrating tablets.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations, commonly known as the Orange Book.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Pfizer	NURTEC ODT	rimegepant sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	212728-001	Feb 27, 2020		RX	Yes	Yes	11,083,724	⤷ Start Trial	Y			ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN ADULTS	⤷ Start Trial
Pfizer	NURTEC ODT	rimegepant sulfate	TABLET, ORALLY DISINTEGRATING;ORAL	212728-001	Feb 27, 2020		RX	Yes	Yes	11,083,724	⤷ Start Trial	Y			PREVENTIVE TREATMENT OF EPISODIC MIGRAINE IN ADULTS	⤷ 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	2019242604	⤷ Start Trial
Brazil	112020019396	⤷ Start Trial
Canada	3094693	⤷ Start Trial
China	112153969	⤷ Start Trial
Denmark	4088720	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Summary for Patent: 11,083,724