US Patent 7,872,049: Claim Scope, Nitroglycerin Oral Spray Protection, and Patent Landscape

US Patent 7,872,049 protects a narrow oral spray formulation containing glyceryl trinitrate, a triglyceride-alcohol vehicle, a low-level buffer, limited water, a medium-chain partial glyceride, and flavoring. The core commercial relevance is formulation protection for pump-delivered nitroglycerin rather than protection for glyceryl trinitrate itself.

The claims require a specific combination of excipients and quantitative limitations. A competing nitroglycerin spray that omits a required component, uses a different vehicle, exceeds the water or buffer limits, or falls outside the triglyceride-to-alcohol ratio may avoid literal infringement. The patent does not broadly cover every oral nitroglycerin spray.

What does US Patent 7,872,049 protect?

The patent protects an oral spray solution containing:

Required element	Claim 1 requirement
Glyceryl trinitrate	About 0.2% to about 5% w/w
Triglyceride and alcohol	Mixed at about 10:90 to about 90:10
Buffer	Less than about 0.5% w/w
Water	Less than about 5.0% w/w
Medium-chain partial glyceride	Required
Flavoring agent	Required
Dosage form	Oral spray solution

Claim 1 is the independent composition claim. Claims 2 through 7 narrow the formulation or define particular excipients and use parameters.

The claim is drafted as a composition claim using the transitional phrase "consisting essentially of." That language generally permits components that do not materially affect the claimed formulation characteristics, while excluding additional ingredients that materially alter the claimed results or formulation system. The boundary is fact-specific and can become important in litigation.

How broad is claim 1 of US 7,872,049?

Claim 1 is broad in its selection of individual ingredients but narrow in its required combination.

A product must contain all of the following to present a straightforward literal-infringement case:

Glyceryl trinitrate within the specified concentration range.
A triglyceride.
An alcohol.
A triglyceride-to-alcohol ratio within approximately 10:90 to 90:10.
A qualifying buffer below 0.5% w/w.
Water below 5.0% w/w.
A medium-chain partial glyceride.
A flavoring agent.
An oral spray solution dosage form.

The claim does not require a particular pump, spray volume, container, propellant, dose per actuation, or indication, except that dependent claim 6 refers to an effective dose for treating angina pectoris when administered with a pump spray.

Why the "consisting essentially of" language matters

A manufacturer cannot necessarily avoid the claim by adding small quantities of conventional excipients. An added ingredient may remain compatible with the claim if it does not materially change the formulation's relevant properties. A substantial additional solvent, emulsifier, preservative, surfactant, or active ingredient could create a stronger non-infringement position if it materially changes the formulation.

The analysis would depend on the patent specification, prosecution history, product composition, and technical effect of the added ingredient. The claim text alone does not establish the boundary for every possible additive.

What do claims 2 through 7 add?

Claim	Scope
Claim 2	Limits the buffer to sodium lactate, disodium monohydrogen phosphate, sodium phosphate, or calcium stearate
Claim 3	Limits water to less than about 0.5% w/w
Claim 4	Defines the triglyceride as a medium-chain triglyceride, plant or semisynthetic triglyceride, saturated C8-C12 fatty-acid triglyceride, or combination
Claim 5	Defines the alcohol as a physiologically compatible alcohol, polyalcohol, propylene glycol, ethanol, absolute ethanol, or combination
Claim 6	Requires glyceryl trinitrate in an effective angina-treatment dose delivered using a pump spray
Claim 7	Limits the triglyceride to about 10%-80% w/w and alcohol to about 10%-80% w/w

Claims 2 and 3 are particularly relevant to formulation design. Claim 3 covers a substantially drier formulation than claim 1. A formulation containing 0.4% water could fall within claim 3 if every other limitation is met; a formulation containing 0.6% water could remain within claim 1 but fall outside claim 3.

Claim 7 introduces a potential numerical inconsistency with claim 1. Claim 1 permits the triglyceride and alcohol to occupy a combined ratio ranging from approximately 10:90 to 90:10. Claim 7 separately places each component between approximately 10% and 80% w/w. The limitations should be read together, but the claim does not require the two components to total a specified percentage because other excipients occupy the balance.

What formulations are protected by US 7,872,049?

The strongest formulation coverage applies to a low-water, nonaqueous or substantially nonaqueous oral spray using a medium-chain triglyceride and an alcohol as the principal vehicle system.

Potentially covered formulation categories include:

Glyceryl trinitrate in medium-chain triglyceride and ethanol.
Glyceryl trinitrate in medium-chain triglyceride and propylene glycol.
Glyceryl trinitrate in a plant-derived triglyceride and ethanol.
Glyceryl trinitrate in a saturated C8-C12 triglyceride and a physiologically compatible alcohol.
Low-water spray solutions containing sodium lactate or phosphate buffer.
Formulations containing a medium-chain partial glyceride and flavoring.

The claim is less likely to reach:

Aqueous nitroglycerin sprays with water above 5% w/w.
Metered-dose aerosol systems using a propellant rather than an oral spray solution.
Sublingual tablets, capsules, transdermal patches, ointments, or intravenous preparations.
Sprays using no triglyceride.
Sprays using a triglyceride but no medium-chain partial glyceride.
Sprays without a flavoring agent.
Formulations using a nonqualifying buffer where the buffer is required to establish a claimed limitation.

How does claim 6 affect infringement analysis?

Claim 6 is a dependent composition claim with an intended-use limitation. It requires an effective glyceryl trinitrate dose for angina pectoris when delivered using a pump spray.

For a composition claim, intended-use language may have limited force where the claimed formulation is structurally defined and is capable of the stated use. A generic sponsor may therefore face risk even if its label uses different wording, provided the product has the claimed composition and is suitable for the claimed administration.

Claim 6 is narrower than claim 1 because it adds the pump-spray and angina-dose context. It may be useful as a fallback claim, but claim 1 is likely the principal infringement target for a formulation that satisfies all listed ingredients and ranges.

What is the likely infringement risk for a generic nitroglycerin spray?

The risk can be organized by formulation element.

Design choice	Effect on risk
Same glyceryl trinitrate concentration	Increases risk
Same triglyceride and ethanol vehicle	Increases risk
No medium-chain partial glyceride	Potentially avoids literal infringement of claim 1
No flavoring agent	Potentially avoids literal infringement
Water at 5% w/w or more	Potentially avoids claim 1
Buffer at 0.5% w/w or more	Potentially avoids claim 1
Nonqualifying buffer	Potentially avoids claims 1 and 2
Triglyceride-to-alcohol ratio outside 10:90 to 90:10	Potentially avoids claim 1
Tablet, patch, or non-spray dosage form	Outside the claimed dosage form
Different active ingredient concentration	May avoid the literal range, subject to equivalents analysis

A design-around based on removal of the medium-chain partial glyceride or flavoring agent would generally be stronger than a minor numerical change. Small deviations can create doctrine-of-equivalents issues, particularly where the accused composition performs the same function in substantially the same way.

When does US Patent 7,872,049 lose exclusivity?

The patent issued on January 18, 2011. The expiration date must be determined from the patent's earliest effective nonprovisional filing date, any applicable patent-term adjustment, terminal disclaimer, and any patent-term extension. Patent issue date alone does not establish the expiration date. The controlling record is the USPTO patent file and the patent's term calculation under 35 U.S.C. §§ 154 and 156.

A formulation patent of this type would ordinarily have a 20-year term measured from the relevant US or international filing date, subject to statutory adjustments. FDA marketing exclusivity and patent term are separate rights. FDA exclusivity can expire before or after the patent.

Does the patent have FDA Orange Book protection?

A patent is not automatically Orange Book-listed merely because it covers an FDA-approved formulation. The sponsor must submit a patent that claims the approved drug, an approved method of using the drug, or another qualifying subject under FDA listing rules.

The Orange Book status of US 7,872,049 must be confirmed against the FDA's current patent listing for the relevant nitroglycerin spray product. The claim text alone does not establish whether the patent was submitted, accepted, delisted, expired, or removed from the Orange Book. FDA listing status also does not determine ultimate validity or enforceability. [2]

What Paragraph IV challenges could target the patent?

A generic applicant could challenge the patent through an ANDA certification if the patent is listed for the relevant reference product and remains legally relevant. The principal Paragraph IV positions would likely include:

Non-infringement

The applicant could formulate the product without one or more required claim elements, such as:

Medium-chain partial glyceride.
Flavoring agent.
Qualifying buffer.
Triglyceride-alcohol ratio within the claimed range.
Water below the claimed threshold.
Oral spray solution dosage form.

Invalidity for anticipation

An anticipation challenge would require a single prior-art reference disclosing every element of the asserted claim arranged as claimed. The reference would need to disclose the combination of glyceryl trinitrate, the triglyceride-alcohol system, buffer, water limit, medium-chain partial glyceride, flavoring agent, and oral spray form.

A reference that discloses nitroglycerin oral spray generally would not necessarily anticipate the claim if it omits the required excipient combination or quantitative ranges.

Invalidity for obviousness

An obviousness challenge could combine references addressing:

Nitroglycerin oral or lingual sprays.
Medium-chain triglyceride vehicles.
Ethanol or propylene glycol solvents.
Low-water pharmaceutical solutions.
Flavoring and taste-masking agents.
Buffer systems for stability or patient acceptability.

The vulnerability would depend on the prior art available before the effective filing date, the claimed technical effect, formulation predictability, and evidence of unexpected stability, dose uniformity, or storage performance. [3]

Written description and enablement

The claims cover multiple triglycerides, alcohols, buffers, partial glycerides, and concentration ranges. A challenger could argue that the specification does not adequately support or enable the full breadth of those combinations. The strength of that argument depends on the examples, working formulations, stability data, and disclosure of representative species.

Which companies are most relevant to the competitive landscape?

The commercially relevant competitors are companies supplying nitroglycerin in spray, sublingual, transdermal, or other dosage forms. The patent is formulation-specific, so competition from tablets or patches may be clinically relevant without creating direct infringement risk.

The relevant market groups are:

Competitor category	Relevance to US 7,872,049
Authorized nitroglycerin oral-spray sponsor	Highest direct product and Orange Book relevance
ANDA sponsor of an equivalent spray	Highest Paragraph IV and launch risk
Sublingual tablet manufacturers	Competitive substitute, limited formulation overlap
Transdermal nitroglycerin manufacturers	Therapeutic substitute, generally outside claim scope
Compounding pharmacies	Potential product overlap but different regulatory pathway
International spray manufacturers	Relevant to foreign patent families and licensing

The patent does not create a monopoly over all nitroglycerin products. Its commercial value depends on whether the approved reference product uses the claimed vehicle and excipient architecture and whether competing products must reproduce those features to obtain equivalent performance.

What patent litigation or settlement agreements affect the patent?

The supplied claim text does not establish a filed infringement action, Paragraph IV notice, consent judgment, or settlement involving US 7,872,049. Litigation status must be confirmed through PACER, the Federal Circuit docket, district-court records, USPTO Patent Center, and FDA Paragraph IV notices.

A settlement could include:

A licensed generic entry date.
A covenant not to sue.
A formulation restriction.
A supply or authorized-generic arrangement.
A payment or commercial-services provision.
A patent challenge waiver.

No settlement term should be inferred solely from the existence of the patent or an FDA-approved nitroglycerin spray.

How strong is the patent estate?

The individual patent appears strongest as a formulation barrier and weaker as a broad active-ingredient or therapeutic-use barrier.

Estate dimension	Assessment
Active ingredient	Weak as a standalone barrier; glyceryl trinitrate is longstanding
Oral spray dosage form	Moderate, depending on other formulation patents
Specific excipient combination	Potentially strong if the approved product practices all limitations
Broad formulation breadth	Constrained by the required partial glyceride, flavoring, buffer, water, and ratio limitations
Method of treatment	Limited; claim 6 is dependent and tied to the composition
Manufacturing process	Not covered by the supplied claims
Device or pump	Not independently claimed
Biosimilar risk	Not applicable in the conventional sense because glyceryl trinitrate is a small molecule
Generic risk	Material if a generic must replicate the claimed formulation

Because glyceryl trinitrate is a small-molecule active ingredient, biosimilar approval is not the relevant competitive pathway. Competition would ordinarily proceed through an ANDA or, for a materially different product, another FDA pathway.

What manufacturing and IP barriers remain?

The claims do not expressly cover manufacturing steps, container-closure systems, pump mechanics, spray plume, dose-metering technology, or packaging. Separate patents could protect those features.

A generic product may still face technical barriers even if it avoids the claims. Relevant development issues include:

Glyceryl trinitrate stability.
Adsorption to packaging materials.
Pump dose uniformity.
Spray delivery and droplet size.
Alcohol-triglyceride miscibility.
Low-water control.
Preservative strategy.
Flavor compatibility.
Container and actuator qualification.
Extractables and leachables.
Content uniformity over shelf life.

These features may be protected by separate formulation, device, packaging, or manufacturing patents. They may also create FDA equivalence and quality-control challenges independent of patent infringement.

Key Takeaways

US 7,872,049 is a formulation patent for a glyceryl trinitrate oral spray solution.
Claim 1 requires a specific combination of active ingredient, triglyceride, alcohol, low-level buffer, limited water, medium-chain partial glyceride, and flavoring.
The patent does not broadly cover all nitroglycerin sprays or all nitroglycerin dosage forms.
Claims 2 through 7 narrow the buffer, water, triglyceride, alcohol, dose, and concentration requirements.
The strongest generic design-around options involve removing a required excipient or changing the vehicle architecture, rather than making a minor concentration adjustment.
Paragraph IV exposure depends on whether the patent was listed for the relevant reference product and remains legally operative.
Biosimilar risk is not the appropriate framework; the relevant risk is generic ANDA competition.
Patent expiration, Orange Book listing, litigation, and settlement status require verification from the current USPTO, FDA, and court records.
The supplied claims do not establish protection for the pump, container, manufacturing process, or spray-device technology.

FAQs

Is US 7,872,049 a patent on Nitrostat tablets?

No. The supplied claims are directed to an oral spray solution. Sublingual tablets and other non-spray nitroglycerin products generally fall outside the express dosage-form limitation.

Can a generic nitroglycerin spray avoid the patent by removing the flavor?

Potentially. Flavoring agent is an express element of claim 1. Removing it could avoid literal infringement, although other patents, formulation requirements, or a doctrine-of-equivalents theory could remain relevant.

Does using propylene glycol create infringement risk?

Yes, if the formulation also contains the other required elements. Claim 5 expressly identifies propylene glycol as a covered alcohol, but the product must still satisfy the independent claim requirements.

Does the patent cover a nitroglycerin transdermal patch?

No, not based on the supplied claims. The claims require an oral spray solution, which is materially different from a transdermal patch.

Is the patent relevant to biosimilar competition?

No. Glyceryl trinitrate is a small-molecule drug. The relevant pathway is generic competition, usually through an ANDA, rather than a biosimilar application.

References

United States Patent No. 7,872,049, claims 1-7 (issued Jan. 18, 2011).
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations (Orange Book).
U.S. Patent and Trademark Office. (2024). Manual of Patent Examining Procedure, §§ 2111, 2113, 2131, 2141-2143.
35 U.S.C. §§ 102, 103, 112, 154, 156.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Pohl Boskamp	NITROLINGUAL PUMPSPRAY	nitroglycerin	SPRAY, METERED;SUBLINGUAL	018705-002	Jan 10, 1997	AB	RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y			METHOD OF TREATING ANGINA PECTORIS	⤷ 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	2009224968	⤷ Start Trial
Brazil	PI0908577	⤷ Start Trial
Canada	2718345	⤷ Start Trial
Germany	202008007318	⤷ Start Trial
European Patent Office	2254552	⤷ Start Trial
Russian Federation	2010142023	⤷ Start Trial
World Intellectual Property Organization (WIPO)	2009112258	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 7,872,049

Which drugs does patent 7,872,049 protect, and when does it expire?

Summary for Patent: 7,872,049