United States Patent 6,770,262: Scope, Claims, Expiration, Orange Book Status, and Metoclopramide Nasal-Spray Patent Landscape

U.S. Patent No. 6,770,262 covers methods of treating gastroparesis with intranasal metoclopramide. Its core protection is a method-of-use combination requiring metoclopramide, nasal administration, and specified dosing parameters. The patent does not broadly claim metoclopramide, a nasal-spray device, or every formulation of intranasal metoclopramide.

The patent was associated with Evoke Pharma’s Gimoti product, a metoclopramide nasal spray approved by the FDA for adults with acute and recurrent diabetic gastroparesis. The Orange Book-listed patent expired on March 22, 2024, based on the listed patent term. As a result, the patent no longer creates a current U.S. patent barrier to an otherwise approvable competing product. FDA regulatory exclusivity, if applicable to a particular product or indication, is separate from patent protection.

What does U.S. Patent 6,770,262 protect?

The patent protects a treatment method with four principal elements:

The patient has gastroparesis or symptoms of gastroparesis.
The active ingredient is metoclopramide or a pharmaceutically acceptable salt.
Administration occurs intranasally, principally as a spray.
The dose falls within specified daily ranges, with some claims requiring treatment for a defined period.

The independent claims are claims 1 and 9.

Claim	Principal limitation	Practical scope
1	Nasal spray; 40-160 mg/day; treatment for 2-8 weeks	Narrow method claim requiring both dosing and duration
9	Nasal spray or drops; 40-160 mg/day	Broader duration scope, but still limited to intranasal delivery
2	Claim 1; 5-8 weeks	Narrows treatment duration
3	Claim 1; approximately 6 weeks	Narrows treatment duration to six weeks
4	Claim 1; 40-80 mg/day	Narrows dose
5	Claim 1; approximately 40 mg/day	Specific low-dose embodiment
6	Claim 1; approximately 80 mg/day	Specific higher-dose embodiment
15	Claims 1 or 9; three or four equal doses	Divided dosing
18	Claims 1 or 9; doses before meals	Meal-related administration
22	Claims 1 or 9; aqueous carrier	Formulation limitation
23	Claims 1 or 9; sustained-release formulation	Release-profile limitation
24	Claims 1 or 9; co-administration with other drugs	Combination-treatment limitation
25-31	Claims 1 or 9; specified causes of gastroparesis	Etiology-specific limitations
32-35	Meal-related dosing; 2-6 weeks	Combined dosing and duration limitations

The patent therefore has a layered claim structure. Claims 1 and 9 establish the primary infringement risk for an intranasal metoclopramide product. The dependent claims add narrower positions covering specific doses, schedules, carriers, release profiles, and disease causes.

How do claims 1 and 9 differ?

Claim 1 is narrower than claim 9 because it requires treatment for approximately two to eight weeks. Claim 9 does not include an express treatment-duration limitation.

Claim 1 also specifically recites a “nasal spray formulation.” Claim 9 covers a “nasal formulation” administered intranasally “as a spray or drops.” A liquid nasal-drop product could fall within claim 9 while avoiding the spray-specific language in claim 1, subject to claim construction and the remaining limitations.

Issue	Claim 1	Claim 9
Delivery route	Intranasal	Intranasal
Dosage form	Nasal spray	Spray or drops
Daily dose	About 40-160 mg/day	About 40-160 mg/day
Duration	About 2-8 weeks	No express duration
Therapeutic objective	Treat or reduce gastroparesis symptoms	Treat or reduce gastroparesis symptoms
Commercial relevance	Closely aligned with a defined treatment course	Broader coverage of ongoing administration

Claim 9 is the principal broad claim for a competing intranasal metoclopramide product because it omits the two-to-eight-week duration requirement.

What dosage ranges are covered by Patent 6,770,262?

The central claimed dose is approximately 40 mg/day to 160 mg/day. Dependent claims narrow the range to approximately 40-80 mg/day and identify 40 mg/day and 80 mg/day as specific embodiments.

The claims also include weight-based dosing:

Claim 13: approximately 0.1-2.5 mg/kg/day.
Claim 14: approximately 0.6-1.2 mg/kg/day.
Claim 8: approximately 0.6-1.2 mg/kg/day, depending on claim 7.

Claim 7, as supplied, recites a range “between about 2.5 mg/kg and about 2.5 mg/kg.” That language describes no meaningful range. It appears to contain a drafting or transcription error. Claim 8 also creates a dependency problem because it depends on claim 7 while reciting a different weight-based range. The scope and enforceability of those claims would depend on the issued patent text, prosecution history, correction procedures, and applicable claim-construction principles.

The word “about” introduces flexibility, but it does not eliminate the need to prove that a dose falls within the claimed range. Courts generally interpret “about” in view of the specification, prosecution history, technical context, and the precision ordinarily used in the relevant field.

What treatment schedules are protected?

The patent covers both fixed-duration and administration-schedule concepts.

Claim 1 requires a two-to-eight-week course. Claims 2 and 3 narrow that course to five-to-eight weeks and approximately six weeks. Claims 32-35 cover meal-related dosing for approximately two to six weeks.

Claims 15-21 address divided dosing:

Three or four equal doses per day.
Administration at equally spaced intervals over 24 hours.
Administration before meals.
Administration before meals and at bedtime.
Approximately 10 mg per dose when four doses are administered.
Approximately 20 mg per dose in specified embodiments.

A 40 mg/day regimen divided into four 10 mg doses is expressly described. An 80 mg/day regimen divided into four 20 mg doses is also covered by the claim architecture.

These limitations matter because a product may use the same active ingredient and route but avoid a narrower dependent claim by using a different schedule. That does not avoid claim 9 if the overall daily dose and intranasal administration remain within claim 9’s scope.

What formulations are protected?

Claims 22 and 23 add formulation limitations:

An aqueous-based carrier.
A sustained-release formulation.

The independent claims do not expressly require an aqueous carrier or sustained release. Those features are narrower alternatives. A standard aqueous nasal spray can fall within claim 22, while a sustained-release intranasal system can fall within claim 23.

The patent does not appear, from the supplied claims, to require:

A particular preservative.
A particular pH.
A particular buffer.
A particular viscosity modifier.
A particular nozzle.
A specific container-closure system.
A specific particle-size distribution.
A particular metoclopramide salt.
A defined excipient combination.

Those elements may be described in the specification or additional patent families, but they are not limitations of claims 1 or 9 unless incorporated through the issued claims.

Does Patent 6,770,262 cover metoclopramide itself?

No. The patent is not a basic compound patent for metoclopramide. Metoclopramide was known and commercially used long before this patent. The claimed advance is the intranasal use of metoclopramide for gastroparesis at specified dosing levels and schedules.

The patent therefore does not prevent:

Oral metoclopramide products.
Injectable metoclopramide products.
Conventional tablets or solutions.
Metoclopramide use for indications outside the claimed gastroparesis methods.
Intranasal products that do not meet the relevant claim limitations, subject to equivalents and claim construction.

The patent is best characterized as a method-of-treatment patent tied to route, dose, formulation, and treatment parameters.

What was the FDA and Orange Book status?

Gimoti, Evoke Pharma’s metoclopramide nasal spray, received FDA approval in 2020 for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.[2] The product was reviewed through an NDA pathway rather than an ordinary ANDA pathway because the nasal delivery route and product characteristics differed from conventional oral metoclopramide products.

The FDA-approved product is a nasal spray containing metoclopramide. Its approved use is narrower than the full disease-cause list recited in claims 25-31. Those claims cover gastroparesis associated with diabetes, postviral syndromes, anorexia nervosa, gastric or vagus-nerve surgery, certain medications, gastroesophageal reflux disease, smooth-muscle disorders, nervous-system diseases, and hypothyroidism.

Regulatory item	Status
Active ingredient	Metoclopramide
Product	Gimoti nasal spray
Sponsor	Evoke Pharma
FDA approval	2020
Approved indication	Acute and recurrent diabetic gastroparesis in adults
Patent listed	U.S. Patent No. 6,770,262
Listed patent expiration	March 22, 2024
Current patent barrier	Expired
Product type	Small-molecule nasal spray
Biosimilar pathway	Not applicable

Patent expiration does not automatically create approval for a competing product. A competitor would still need to satisfy FDA requirements for quality, performance, bioequivalence or clinical bridging, manufacturing controls, labeling, and device performance.

When did Patent 6,770,262 lose exclusivity?

The patent’s listed expiration date was March 22, 2024. After that date, the patent ceased to provide enforceable U.S. patent exclusivity, absent a separate enforceable right such as an applicable patent-term extension, reissue claim, continuation patent, or other distinct patent covering the product.

The patent’s expiration also changes the Paragraph IV analysis. Before expiration, an ANDA applicant could challenge the listed patent through a Paragraph IV certification. After expiration, the patent no longer requires a Paragraph IV attack for a future filing, although the applicant may still need to address other listed patents, regulatory exclusivity, or product-specific requirements.

Milestone	Date or period
Patent issued	2004
Gimoti FDA approval	2020
Listed patent expiration	March 22, 2024
Post-expiration commercial status	Patent no longer blocks entry

Were there Paragraph IV challenges or patent settlements?

The commercial significance of a Paragraph IV challenge was greatest before March 22, 2024. A generic or alternative nasal product seeking entry before expiration would have needed to evaluate whether its proposed labeling and product design infringed claims 1 or 9 and whether the claims were valid and enforceable.

No widely reported public patent-settlement framework established an earlier generic launch date for U.S. Patent 6,770,262. The record associated with the product is principally a branded-product patent listing and FDA approval rather than a widely publicized Hatch-Waxman settlement involving an authorized generic or negotiated entry date.

Following expiration, a Paragraph IV challenge to this patent would have little commercial purpose. Any current entry analysis should focus on other patents, FDA exclusivity, formulation and device rights, and regulatory approval requirements.

Which companies are challenging or competing with Gimoti?

The competitive landscape has three groups:

Conventional metoclopramide manufacturers

Generic manufacturers sell oral metoclopramide tablets, orally disintegrating tablets, solutions, and injections. These products compete on active ingredient and price but generally do not compete directly with Gimoti’s intranasal route.

Alternative intranasal developers

A company developing intranasal metoclopramide would compete directly with Gimoti. Its key issues would include:

Nasal absorption and exposure.
Device reproducibility.
Dose uniformity.
Local tolerability.
Labeling for diabetic gastroparesis.
Formulation stability.
Whether the product falls within any surviving patent claims.

Non-metoclopramide therapies

Gastroparesis treatment also includes dietary management, glycemic control, antiemetic therapy, prokinetic approaches, and, in selected cases, procedural or device-based interventions. These alternatives do not necessarily create patent freedom-to-operate issues under Patent 6,770,262 because they do not use intranasal metoclopramide.

Is there biosimilar risk for Gimoti?

No conventional biosimilar pathway applies. Metoclopramide is a small molecule, not a biological product. A competing product would be evaluated through an abbreviated or full small-molecule drug pathway, depending on the reference product, formulation, route, and regulatory differences.

The practical competitive risk is therefore generic or follow-on nasal metoclopramide competition, not biosimilar substitution.

How strong was the patent estate?

The patent was commercially meaningful while in force because it connected a known drug to a differentiated route of administration and a specific gastroparesis treatment regimen. Its strength was limited by several factors.

Strengths

Claims 1 and 9 directly addressed the commercial concept of nasal metoclopramide for gastroparesis.
Claim 9 omitted a fixed treatment duration.
Claims covered both spray and drops.
Dependent claims added dosing, meal timing, carrier, and sustained-release positions.
The patent supported an FDA-approved nasal product.

Limitations

The claims do not cover metoclopramide generally.
The claims are method claims, so infringement requires use for the claimed therapeutic purpose.
Dose and route must fall within the claimed parameters.
Many dependent claims are narrower than the commercial product concept.
The supplied claim set includes apparent drafting errors, particularly claims 7, 8, 10, 25, and 28.
The patent expired in 2024.

The estate’s current strength is therefore historical rather than blocking. A freedom-to-operate review for a new nasal product should search continuation patents, formulation patents, device patents, manufacturing patents, and any later-assigned rights separately.

What manufacturing and intellectual-property barriers remain?

Expiration of Patent 6,770,262 does not eliminate technical barriers. A competing developer would still need to address:

Stable metoclopramide concentration in the nasal formulation.
Accurate metered delivery.
Spray plume and droplet-size consistency.
Nasal mucosal tolerability.
Preservative compatibility.
Container-closure integrity.
Manufacturing reproducibility.
Extractables and leachables.
Product performance over shelf life.
Clinical or pharmacokinetic bridging.
Labeling and postmarketing requirements.

A developer may also encounter later patents covering a specific pump, formulation, excipient combination, manufacturing process, or use limitation. Those rights must be analyzed independently from Patent 6,770,262.

What generic launch scenarios exist after expiration?

Three principal entry scenarios exist.

Scenario	Description	Primary risk
Direct nasal follow-on	Competing metoclopramide nasal spray	FDA approval and formulation/device performance
Nasal drops	Intranasal liquid delivered as drops	Route, dosing accuracy, clinical comparability
Oral or injectable generic	Conventional metoclopramide product	Competes economically but not directly with Gimoti

A direct nasal competitor may have a clearer patent position after expiration, but it may face a more demanding regulatory path than an oral generic. The product’s delivery system is part of the therapeutic performance profile, and the FDA may require evidence beyond simple active-ingredient sameness.

How does Patent 6,770,262 compare with conventional metoclopramide patents?

Feature	Patent 6,770,262	Conventional metoclopramide patents
Patent category	Method of treatment	Compound, formulation, or conventional use
Route	Intranasal	Usually oral or injectable
Disease focus	Gastroparesis	Broader antiemetic and gastrointestinal uses
Dose limitation	Central to claims	Varies
Device dependence	Relevant to commercial product, not expressly central to claims	Usually limited
Current status	Expired in 2024	Many older rights also expired
Biosimilar relevance	None	None

Key Takeaways

U.S. Patent 6,770,262 covers intranasal metoclopramide methods for treating or reducing gastroparesis symptoms.
Claims 1 and 9 are the principal independent claims.
Claim 1 requires a two-to-eight-week treatment period; claim 9 does not.
The principal dose range is approximately 40-160 mg/day.
Dependent claims cover 40 mg/day, 80 mg/day, divided dosing, premeal dosing, aqueous carriers, sustained release, and specific causes of gastroparesis.
The patent does not claim metoclopramide itself or all metoclopramide products.
The patent was listed for Gimoti, Evoke Pharma’s metoclopramide nasal spray.
The listed expiration date was March 22, 2024.
Biosimilar risk is inapplicable because metoclopramide is a small molecule.
Current entry risk depends on FDA approval, device and formulation performance, and any later patent rights, not on Patent 6,770,262.

FAQs

Can a company sell oral metoclopramide without infringing Patent 6,770,262?

Yes, the patent is directed to intranasal administration. Oral metoclopramide products generally do not meet the route limitation in claims 1 or 9.

Does an intranasal metoclopramide product automatically infringe the patent?

No. Infringement would require the product and use to satisfy the applicable claim limitations, including the route, therapeutic purpose, and claimed dose. The patent expired on March 22, 2024.

Does the patent cover metoclopramide nasal drops?

Claim 9 expressly recites intranasal administration as a spray or drops. That coverage was relevant before expiration, subject to the other claim elements.

Is Gimoti protected by a biologic exclusivity period?

No. Gimoti contains metoclopramide, a small-molecule drug. Its competitive framework is based on small-molecule drug approval and patent analysis, not biosimilar interchangeability.

What is the main freedom-to-operate issue for a new nasal metoclopramide product?

The principal issue is whether later patents cover the product’s formulation, delivery device, manufacturing process, or specific use. Patent 6,770,262 itself expired in 2024.

References

United States Patent and Trademark Office. (2004). U.S. Patent No. 6,770,262: Methods of treating gastroparesis.
U.S. Food and Drug Administration. (2020). FDA approves nasal spray to treat diabetic gastroparesis.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. Orange Book.
U.S. Food and Drug Administration. (2020). Gimoti (metoclopramide) nasal spray prescribing information. Evoke Pharma, Inc.
Evoke Pharma, Inc. (2024). Annual report on Form 10-K. U.S. Securities and Exchange Commission.

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	466569	⤷ Start Trial
Australia	4968401	⤷ Start Trial
Canada	2403994	⤷ Start Trial
Cyprus	1111396	⤷ Start Trial
Germany	60142037	⤷ Start Trial
Denmark	1274414	⤷ Start Trial
European Patent Office	1274414	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 6,770,262

Summary for Patent: 6,770,262