United States Drug Patent 10,933,060: Claim Scope, Exclusivity, Litigation Risk, and Patent Landscape

U.S. Patent No. 10,933,060 protects a specific clinical method for inducing local anesthesia in the nasal cavity with an aqueous cocaine hydrochloride solution applied through four absorbent articles. The independent claim is narrow but commercially relevant because it tracks the administration technique, concentration range, excipient profile, exposure limits, and pharmacokinetic results associated with 4% topical cocaine hydrochloride use. The patent issued March 2, 2021, and has a nominal expiration date in 2036, subject to patent-term adjustment and any applicable regulatory extension. [1]

The patent does not broadly claim all cocaine nasal anesthetic products. Its primary risk attaches to use of a defined solution, delivered on four pledgets, for specified nasal procedures and producing defined pharmacokinetic and absorptivity outcomes.

What does U.S. Patent 10,933,060 protect?

The patent protects a method of inducing local anesthesia before a procedure involving or adjacent to the nasal mucosa. Claim 1 requires every one of the following limitations:

Claim element	Required limitation
Patient and anatomy	A patient with a nasal cavity mucous membrane
Clinical purpose	Induction of local anesthesia before a medical procedure
Delivery articles	Four absorbent articles
Solution	Aqueous cocaine hydrochloride solution
Cocaine concentration	About 36 to 44 mg/mL
Citric acid	About 1.2 to 1.4 mg/mL
Sodium benzoate	About 0.7 to 1.3 mg/mL
Solvent	Water
Administration	Contact with the nasal mucosa
Contact period	Up to about 20 minutes
Pharmacokinetics	Absorptivity factor for cocaine from about 0.25 h−1 to 1.0 h−1

The claim is therefore a combination claim. A potentially infringing use must practice the formulation, the four-article delivery method, the nasal procedure context, and the pharmacokinetic limitation.

The claim is narrower than a claim covering cocaine hydrochloride as a composition, a nasal anesthetic generally, or any topical cocaine product.

How do the dependent claims expand the patent scope?

Claims 2 through 12 add delivery formats, procedures, and pharmacokinetic outcomes.

Claims	Protected subject matter
2-3	Absorbent articles comprising pledgets, including cottonoid pledgets
4	Each pledget retains approximately 70% to 80% of cocaine hydrochloride after removal
5-9	Nasal endoscopy, nasal laryngoscopy, nasopharyngeal laryngoscopy, or nasal debridement
10	Tmax from approximately 0.02 to 1.00 hours
11	Cocaine AUCinf from approximately 25.0 to 370 ng·h/mL
12	Pain reduction equivalent to a visual numeric rating score of 0 on von Frey filament testing

Claims 6 through 9 are procedure-specific species of claim 5. They do not materially broaden the patent. They create separate infringement positions if the broader procedure limitation is challenged or found indefinite.

Claim 4 is especially dependent on factual testing. It requires that each pledget retain 70% to 80% of the cocaine hydrochloride. That limitation may be difficult to establish in routine clinical use unless the patentee can rely on validated product testing, manufacturing specifications, or an established administration protocol.

Claims 10 and 11 define pharmacokinetic results rather than only formulation or administration steps. A competing method could use a chemically similar formulation yet fall outside the patent if it produces a different Tmax, AUCinf, or absorptivity factor. The reverse also applies: a method that does not intentionally target the claimed pharmacokinetic profile may still infringe if the result necessarily occurs.

What formulation is covered by Patent 10,933,060?

The claimed solution is an approximately 4% cocaine hydrochloride formulation with narrow excipient ranges:

Component	Claimed range
Cocaine hydrochloride	36-44 mg/mL
Citric acid	1.2-1.4 mg/mL
Sodium benzoate	0.7-1.3 mg/mL
Water	Balance

The cocaine concentration corresponds to the 4% strength of topical cocaine hydrochloride solution. FDA-approved Numbrino contains cocaine hydrochloride in 4% and 10% strengths and is indicated for induction of local anesthesia of the mucous membranes of the nasal cavities for diagnostic and surgical procedures. [2]

The patent claim does not cover every 4% cocaine hydrochloride formulation. A product may avoid literal infringement by changing one or more claimed excipient ranges, using a different preservative system, changing the delivery article count, or using a delivery vehicle other than the claimed aqueous solution. The doctrine of equivalents could limit the value of purely numerical design-arounds where the substituted component performs substantially the same function in substantially the same way with substantially the same result.

Does the patent cover Numbrino?

The claim profile closely corresponds to the clinical administration of 4% topical cocaine hydrochloride used with nasal pledgets. Numbrino’s prescribing information describes placement of soaked cottonoid pledgets in the nasal cavity, with removal after the specified application period. [2]

The patent’s commercial relevance depends on whether the marketed label, product instructions, and ordinary clinical use satisfy all limitations of claim 1. The strongest overlap is likely to involve:

4% cocaine hydrochloride solution;
aqueous formulation;
nasal mucosal application;
four cottonoid pledgets;
application before nasal procedures; and
exposure periods within 20 minutes.

The pharmacokinetic limitations create a separate infringement issue. Product labeling may establish intended use, but absorptivity factor, Tmax, and AUCinf are normally proven through clinical or pharmacokinetic evidence rather than label language alone.

When does Patent 10,933,060 expire?

The patent has a nominal term extending into 2036. Based on the patent family’s 2016 priority period, the ordinary 20-year term is expected to run to approximately August 2036, before any patent-term adjustment. [1]

Event	Date or status
Earliest reported priority period	2016
U.S. patent application	Filed before issuance
Patent issued	March 2, 2021
Nominal expiration	Approximately August 2036
Patent-term adjustment	Must be added if shown on the issued patent
Patent-term extension	No extension is established by the claim text

The controlling expiration date is the USPTO term calculation, not simply the 20-year anniversary of the issue date. Patent-term adjustment, terminal disclaimers, continuation relationships, and priority claims can alter the effective date.

What is the Orange Book status of Patent 10,933,060?

Patent 10,933,060 is associated with the Numbrino regulatory and patent estate. FDA’s Orange Book is the operative source for determining whether the patent is currently listed against the approved cocaine hydrochloride product, the listed expiration date, and any use-code description. [3]

For an ANDA applicant, the practical questions are:

Whether the patent is listed for the relevant Numbrino strength.
Whether the listing carries a method-of-use code.
Whether the proposed ANDA labeling includes the patented nasal procedures.
Whether the applicant can use a Paragraph III certification, Paragraph IV certification, or a section viii statement.
Whether the patent’s listing remains active at the time of ANDA filing.

Because the patent is directed to a method of use, a generic applicant may attempt to omit the patented procedure from its labeling through a section viii statement. That strategy is limited if the remaining label still encourages the patented administration method or if the claimed use is inseparable from the approved indication.

How strong is the patent estate for cocaine hydrochloride nasal anesthesia?

Patent 10,933,060 has moderate claim breadth and potentially high product relevance.

Strengths

It claims a commercially recognizable 4% formulation.
It requires a defined four-pledget administration protocol.
It includes pharmacokinetic result limitations that may correspond to the reference product.
It covers common nasal diagnostic and surgical procedures.
It can support a method-of-use infringement theory against clinical use or label-directed generic use.

Weaknesses

Claim 1 is highly combination-specific.
A competitor may alter the formulation or delivery protocol.
Pharmacokinetic limitations can create proof problems.
Medical-use claims are vulnerable to label carving and noninfringing-use arguments.
The claims do not independently protect the active ingredient, the 4% solution as a composition, or all nasal cocaine administration methods.

The patent is stronger against a generic that copies the reference product’s formulation and four-pledget instructions than against a competitor using a different strength, different excipient system, fewer or more pledgets, or another nasal anesthetic.

What prior patents and related rights affect the landscape?

The relevant landscape has several layers:

Composition and formulation patents

Other members of the cocaine hydrochloride patent family may claim the formulation itself, excipient combinations, stability characteristics, or concentration ranges. Those patents can present a broader barrier than Patent 10,933,060 because they may apply regardless of whether a particular physician uses four pledgets.

A formulation patent can also create infringement risk for a generic even where the generic removes the patented procedure from its label.

Method-of-use patents

Patent 10,933,060 is principally a method-of-use patent. Its scope turns on the manner of administration and procedure. Method claims may remain commercially important after composition patents expire if the approved label continues to direct the patented use.

Manufacturing and quality controls

Cocaine hydrochloride is a controlled substance. Manufacturing requires Drug Enforcement Administration controls, secure handling, inventory procedures, quota compliance, and qualified suppliers. [4] Those regulatory barriers do not extend patent life, but they can slow generic development and reduce the number of capable manufacturers.

A generic manufacturer must also demonstrate pharmaceutical equivalence, product quality, sterility or microbiological controls where applicable, stability, container-closure compatibility, and controlled-substance compliance.

Regulatory exclusivity

Numbrino was approved by FDA in January 2020. [2] Any original drug or orphan-drug exclusivity periods must be evaluated separately from patent expiration. Regulatory exclusivity can block approval even when no patent infringement exists, while patent rights can continue after regulatory exclusivity ends.

Cocaine hydrochloride is a small molecule, so biosimilar pathways do not apply. Competition would proceed through an ANDA or, for a materially different product, a 505(b)(2) application rather than a biosimilar application.

Which companies are likely to challenge the patent?

A generic applicant seeking to market an equivalent topical cocaine hydrochloride product would be the most likely Paragraph IV challenger. The commercial incentive is greatest for a company able to manufacture a controlled-substance nasal product and obtain access to the relevant distribution and compliance infrastructure.

Potential challenge theories include:

the claims are anticipated by earlier cocaine hydrochloride nasal anesthesia disclosures;
the claimed ranges are obvious combinations of known formulation and administration parameters;
the pharmacokinetic limitations are inherent or expected results;
the claims lack written-description support for the full numerical ranges;
the claims are indefinite because terms such as "about," "absorptivity factor," or "equivalent to" lack objective boundaries;
the proposed generic labeling does not induce the patented method;
the generic uses a noninfringing formulation or administration protocol.

No specific challenger or filed Paragraph IV litigation can be identified from the claim text alone. The relevant docket and FDA listing must be reviewed for a current litigation determination.

What Paragraph IV and generic-launch risks exist?

A Paragraph IV certification would allege that the patent is invalid, unenforceable, or not infringed. If the patent is listed in the Orange Book, timely patent litigation by the brand owner can trigger the statutory 30-month stay on final FDA approval, subject to the Hatch-Waxman framework. [5]

Generic launch scenarios include:

Scenario	Commercial result
No challenge	Launch generally waits for patent and exclusivity barriers to clear
Paragraph III certification	Approval is deferred until patent expiration
Paragraph IV with no suit	Approval may proceed after statutory requirements are satisfied
Paragraph IV with timely suit	Approval may be stayed for up to 30 months, subject to court action
Section viii carve-out	Approval may proceed for non-patented uses if labeling is adequately limited
Successful invalidity or noninfringement case	Earlier launch becomes possible
At-risk launch	Generic may launch before final resolution, exposing itself to damages and injunction risk

The most credible design-around would avoid at least one central claim limitation while preserving clinical utility. Examples include a different concentration outside 36-44 mg/mL, a different preservative system, a different number of pledgets, or an administration period and clinical protocol that do not produce the claimed pharmacokinetic profile.

What patent litigation affects Patent 10,933,060?

A litigation search must distinguish between:

cases expressly naming Patent 10,933,060;
cases involving related family members;
ANDA litigation concerning Numbrino;
declaratory judgment actions;
post-grant review or inter partes review proceedings; and
commercial disputes involving licensing or supply arrangements.

The patent number itself does not establish that litigation has been filed or that a claim has been adjudicated. Any current litigation conclusion should be based on PACER, court docket records, USPTO Patent Center, and FDA Orange Book updates.

Are there licensing deals for this patent?

The commercial rights surrounding Numbrino are associated with the product sponsor and its development and commercialization partners. A patent assignment, exclusive license, co-development agreement, or supply agreement may affect enforcement rights even when the patent record identifies a different owner from the marketed product sponsor.

A patent assignment does not necessarily disclose all license economics. Royalty rates, field-of-use restrictions, territorial rights, sublicensing rights, and change-of-control provisions generally require review of SEC filings, transaction documents, or publicly reported company agreements.

How does Patent 10,933,060 compare with competing nasal anesthetic products?

Product or approach	Active ingredient	Delivery	Patent risk relative to 10,933,060
Numbrino 4%	Cocaine hydrochloride	Nasal pledgets	Highest overlap
Numbrino 10%	Cocaine hydrochloride	Nasal pledgets	Formulation may fall outside the 36-44 mg/mL limitation, but other family patents may apply
Lidocaine nasal products	Lidocaine	Spray, gel, pledget, or other delivery	Generally outside the literal cocaine claims
Tetracaine or other local anesthetics	Non-cocaine anesthetic	Product-specific	Usually outside this patent
Compounded cocaine solutions	Cocaine hydrochloride	Variable	Risk depends on formulation, article count, procedure, and pharmacokinetics

The patent creates a targeted barrier around a particular cocaine nasal anesthesia protocol. It does not prevent competition from non-cocaine local anesthetics.

Key Takeaways

Patent 10,933,060 is a narrow but commercially aligned method patent for 4% cocaine hydrochloride nasal anesthesia.
Claim 1 requires four absorbent articles, a defined aqueous formulation, nasal mucosal contact, a maximum application period, and a specified absorptivity factor.
The dependent claims cover pledgets, cottonoid pledgets, specific nasal procedures, cocaine retention, Tmax, AUCinf, and pain-response outcomes.
The patent does not broadly claim all cocaine hydrochloride compositions or all nasal anesthetic methods.
Its nominal expiration is in 2036, subject to USPTO patent-term adjustment and other term calculations.
Generic risk is highest for a product copying the 4% formulation and four-pledget clinical instructions.
A section viii label carve-out or formulation and delivery redesign could reduce infringement exposure.
Cocaine hydrochloride is a small molecule. Biosimilar competition is not relevant.
Controlled-substance manufacturing and distribution requirements create practical barriers independent of patent rights.
Current Orange Book listing, litigation, settlement, and licensing conclusions require review of the live FDA, USPTO, court, and transaction records.

FAQs About U.S. Patent 10,933,060

Does Patent 10,933,060 cover 10% cocaine hydrochloride?

Not on the face of the supplied claims. Claim 1 requires approximately 36-44 mg/mL cocaine hydrochloride, which corresponds to an approximately 4% solution. A 10% solution is approximately 100 mg/mL and falls outside that numerical limitation, although related patents may create separate exposure.

Can a generic use fewer than four pledgets?

A method using fewer than four pledgets would not literally satisfy the "soaking four absorbent articles" limitation of claim 1. Risk under the doctrine of equivalents would depend on the technical and legal circumstances.

Does the patent cover nasal sprays?

The supplied claims require soaking four absorbent articles and contacting those articles with the nasal mucosa. A conventional nasal spray does not literally practice that delivery limitation, although other patents or induced-infringement theories may apply.

Can a physician infringe by using the patented method?

Potentially. A physician who performs every step of an issued method claim can be a direct infringer under 35 U.S.C. § 271(a). Commercial exposure often focuses on manufacturers, suppliers, labeling, and inducement under section 271(b).

Is Patent 10,933,060 a biosimilar barrier?

No. Cocaine hydrochloride is a chemically synthesized small-molecule active ingredient. A competing product would generally use the ANDA or 505(b)(2) pathway, not the biosimilar pathway under the Public Health Service Act.

References

United States Patent and Trademark Office. (2021). U.S. Patent No. 10,933,060, methods of administering cocaine hydrochloride.
U.S. Food and Drug Administration. (2020). Numbrino (cocaine hydrochloride) nasal solution: Prescribing information.
U.S. Food and Drug Administration. (n.d.). Approved drug products with therapeutic equivalence evaluations: Orange Book.
U.S. Drug Enforcement Administration. (n.d.). Controlled substances ordering system and manufacturer requirements.
U.S. Food and Drug Administration. (2015). Guidance for industry: 180-day exclusivity when multiple ANDAs are submitted on the same day.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Lxo Ireland	GOPRELTO	cocaine hydrochloride	SOLUTION;NASAL	209963-001	Dec 14, 2017		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				METHOD FOR THE INDUCTION OF LOCAL ANESTHESIA OF THE MUCOUS MEMBRANES	⤷ Start Trial
Omnivium Pharms	NUMBRINO	cocaine hydrochloride	SOLUTION;NASAL	209575-001	Jan 10, 2020		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				METHOD FOR THE INDUCTION OF LOCAL ANESTHESIA PRIOR TO PERFORMING A PROCEDURE ON, THROUGH, OR ADJACENT TO THE MUCOUS MEMBRANES	⤷ Start Trial
Omnivium Pharms	NUMBRINO	cocaine hydrochloride	SOLUTION;NASAL	209575-001	Jan 10, 2020		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				METHOD FOR THE INDUCTION OF LOCAL ANESTHESIA OF THE MUCOUS MEMBRANES	⤷ 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

Details for Patent: 10,933,060

Which drugs does patent 10,933,060 protect, and when does it expire?

Summary for Patent: 10,933,060