US Patent 7,910,767: Scope, Claim Construction, Expiration, and Prostaglandin-Nitrooxy Patent Landscape

US Patent 7,910,767 covers nitrooxy derivatives of prostaglandin analogs, including derivatives based on latanoprost, travoprost, unoprostone, and cloprostenol. Its principal inventive concept is the covalent attachment of a nitric-oxide-donating nitrate group, usually through an oxygen, sulfur, or amino linker, to a prostaglandin pharmacophore used for lowering intraocular pressure.

The patent is relevant to latanoprostene bunod, marketed as Vyzulta. Its broad foundational composition claims appear to have reached the end of their ordinary US patent term, subject to any patent-term adjustment, terminal disclaimer, or other post-grant event recorded in the USPTO file. Later patents, formulation claims, method-of-use claims, and regulatory exclusivities may have provided or may still provide separate protection for commercial products.

What invention does US Patent 7,910,767 protect?

The patent protects compounds that combine two pharmacological elements:

A prostaglandin residue, including residues derived from latanoprost and other ophthalmic prostaglandin analogs.
A nitrooxy group, represented by -ONO2, attached through a defined divalent linker.

The intended pharmacology is dual-action ocular pressure reduction. The prostaglandin portion is designed to increase aqueous humor outflow, while the nitrate portion is intended to release nitric oxide or generate nitric-oxide-related signaling that can further reduce intraocular pressure.

The core structure in claim 1 is:

R-X-Y-ONO2

where:

R is a prostaglandin residue;
X is oxygen, sulfur, or NH;
Y is a broad divalent linker;
-ONO2 is a nitrate ester or nitrooxy substituent.

The claim therefore does not protect only one named molecule. It creates a Markush genus covering multiple prostaglandin cores, linker lengths, substitution patterns, heterocycles, stereoisomers, salts, and nitrate-bearing side chains.

How broad is claim 1 of US 7,910,767?

Claim 1 is the principal composition-of-matter claim and is substantially broader than the commercial compound latanoprostene bunod.

Claim element	Scope
Prostaglandin residue R	Formula II, with multiple permitted L configurations
Linker atom X	O, S, or NH
Divalent radical Y	Alkylene, substituted alkylene, cycloalkylene, ester-linked, ether-linked, thioether-linked, and heterocyclic structures
Linker length	Several ranges extending as high as C1-C20 in the broadest language
Substituents	Halogen, hydroxy, nitrate, nitrate-containing ester, and nitrate-containing ether substituents
Nitric oxide donor	Direct or indirectly connected `-ONO2` group
Stereochemistry	Stereoisomers are expressly included
Solid form	Pharmaceutically acceptable salts are included

The practical scope is determined by the complete structural drawings and definitions incorporated into the issued patent. The claim text supplied in the question omits several Markush drawings and contains OCR or transcription errors. Those missing structures are material because they define the exact limits of the linker classes and the prostaglandin residue.

What does the prostaglandin residue limitation do?

The R limitation anchors the invention to a prostaglandin pharmacophore. Dependent claims 4 and 5 identify specific residues:

Travoprost
Unoprostone
Cloprostenol
Latanoprost

Claim 5 is particularly important because it narrows the patent to nitrooxy derivatives of latanoprost. Latanoprostene bunod is the commercial example associated with this claim family.

The patent does not claim unmodified latanoprost. A product must contain the specified nitrooxy-linked derivative architecture to fall within the composition claims.

Which claims are most relevant to latanoprostene bunod?

Latanoprostene bunod is an isopropyl ester prostaglandin analog containing a nitrooxypropyl substituent. The commercial molecule is commonly described as a nitric-oxide-donating derivative of latanoprost.

The most relevant claims are:

Claim	Commercial relevance
Claim 1	Broad genus covering nitrooxy prostaglandin derivatives
Claim 5	Latanoprost residue limitation
Claim 6	Narrows X to oxygen or sulfur
Claim 7	Narrows Y to selected C2-C6 alkylene and related structures
Claim 8	Further narrows the alkylene and nitrate arrangement
Claim 10	Specific compounds, but the supplied text omits the compound list
Claims 13-16	Pharmaceutical composition and topical ophthalmic forms
Claim 19	Combination with timolol or a nitrooxy derivative of timolol

Claims 7 and 8 appear to be the closest structural narrowing claims for the commercially relevant nitrooxypropyl arrangement. Claim 10 could be decisive because it may list named or depicted species, but the compound structures are missing from the supplied claim text.

What does claim 11 protect?

Claim 11 is a process claim. It covers preparation of the claimed nitrate derivatives by:

Reacting a prostaglandin-derived intermediate with a linker reagent;
Using a leaving group such as chlorine, bromine, iodine, mesylate, or tosylate where applicable;
Introducing the nitrate group through a nitrate source;
Optionally removing a protecting group.

The process claim reaches both:

Direct coupling to a reagent already containing -ONO2; and
Coupling through an activated intermediate followed by nitrate substitution.

This claim can create manufacturing risk even where a competing product avoids the exact final compound claims, but only if the competitor uses a process within the defined sequence and reagent limitations. Process infringement depends on actual manufacturing steps, which are usually difficult to establish without discovery, regulatory filings, or source-code-equivalent manufacturing evidence.

What do claims 12 through 19 cover?

Claims 12 through 19 extend the invention beyond compounds.

Claims	Subject matter
12	Claimed compounds for use as medicines
13	Pharmaceutical compositions containing the compounds
14	Topical pharmaceutical compositions
15	Treatment of glaucoma and ocular hypertension
16	Solutions, suspensions, or emulsions in ophthalmic vehicles
17	Method of reducing and maintaining reduced intraocular pressure
18	Combination therapy with beta-blockers, carbonic anhydrase inhibitors, adrenergic agonists, or nitrooxy derivatives
19	Combination therapy specifically involving timolol

The method claims are narrower than the broad composition claim in one respect: they require treatment of glaucoma or ocular hypertension. They may still cover multiple dosage forms and prostaglandin-nitrooxy species if the administered product meets the incorporated composition limitations.

What formulation patents are separate from US 7,910,767?

US 7,910,767 primarily concerns the active compounds and broad pharmaceutical uses. Commercial product protection may also depend on later patents directed to:

Aqueous ophthalmic formulations;
pH and buffer systems;
Solubilization and preservative systems;
Stability of latanoprostene bunod;
Specific concentrations and dosing regimens;
Containers and delivery devices;
Combination treatment with other glaucoma agents.

A generic manufacturer can avoid a formulation claim by using a different excipient system while still infringing an active-ingredient claim. Conversely, a non-infringing active ingredient does not become infringing merely because it uses a similar ophthalmic vehicle.

What is the FDA regulatory status of the associated product?

Latanoprostene bunod ophthalmic solution 0.024% was approved by the FDA under NDA 208254 in 2017 for reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The product is marketed as Vyzulta by Bausch + Lomb. The active ingredient is latanoprostene bunod.

The FDA approval is distinct from patent protection. FDA approval establishes lawful marketing status; it does not determine whether a particular patent claim is valid or infringed.

Regulatory item	Status
Active ingredient	Latanoprostene bunod
Product	Vyzulta
Dosage form	Ophthalmic solution
Strength	0.024%
Indication	Open-angle glaucoma and ocular hypertension
FDA pathway	NDA
Original approval	2017
Commercial rights	Associated with Bausch + Lomb and Nicox

Sources include the FDA prescribing information, FDA Drugs@FDA records, and Nicox public disclosures.[2-4]

What is the Orange Book status of US 7,910,767?

The Orange Book listing must be distinguished from the patent’s underlying validity and enforceability.

US 7,910,767 is associated with the foundational nitrooxy-prostaglandin technology relevant to Vyzulta. Its practical significance depends on:

Whether it was listed for the approved drug;
The specific expiration date recorded by FDA;
Any patent-term adjustment;
Whether the patent was removed, expired, or superseded by later listed patents;
The scope of the approved product claims relative to the listed patent claims.

A patent can remain technically valid but have no remaining enforceable term after expiration. Conversely, an Orange Book-listed patent does not establish that every generic product would infringe it.

For Vyzulta, the commercially important patent landscape extends beyond US 7,910,767 and includes later patents that may cover the product, its formulation, or its therapeutic use. The FDA Orange Book and the relevant patent records should be read together rather than treating the 7,910,767 grant as the entire estate.[1,5]

When does US Patent 7,910,767 lose exclusivity?

US Patent 7,910,767 issued on March 22, 2011. The patent’s ordinary term is calculated from the applicable US nonprovisional filing date or earliest effective filing date, subject to patent-term adjustment and any terminal disclaimer.

Public patent records identify the patent as a Nicox-related nitrooxy-prostaglandin patent. Its practical exclusivity period is associated with an early-2000s priority and filing history, placing the ordinary term in the 2020s rather than the 2030s. The exact enforceable expiration must be taken from the USPTO Patent Center record and the patent’s term-adjustment calculation.

The key commercial point is that the foundational patent is materially older than the later Vyzulta formulation and method patents. A generic entrant therefore needs to analyze the entire remaining patent estate, not only US 7,910,767.

What Paragraph IV risks exist for generic latanoprostene bunod?

A generic applicant filing an ANDA under Paragraph IV could challenge patents listed for Vyzulta by alleging that they are:

Invalid;
Unenforceable;
Not infringed; or
Improperly listed for the approved product.

The principal technical defenses against the foundational patent could include:

Claim construction

The applicant could argue that the proposed product lacks the claimed prostaglandin residue, linker configuration, stereochemistry, or nitrate attachment.

Anticipation

Prior-art prostaglandin analogs and organic nitrate compounds could be relevant, but anticipation requires a single reference to disclose every required claim element in the claimed arrangement.

Obviousness

The strongest obviousness theory would likely combine:

Known prostaglandin analogs for glaucoma;
Known nitric oxide donors;
Known nitrate ester chemistry; and
A motivation to combine the two mechanisms.

The patent holder would respond that the claimed compounds required a particular structural design, demonstrated ocular activity, acceptable tolerability, and pharmacokinetic behavior.

Written description and enablement

Claim 1 covers a very large genus. A challenger could argue that the specification does not adequately describe or enable the full range of prostaglandin residues, linkers, stereoisomers, and heterocyclic structures.

Indefiniteness

The supplied claim text contains apparent transcription defects, including incomplete structural definitions and inconsistent numbering. In litigation, the controlling document would be the issued patent and its official drawings, not an OCR version. Indefiniteness analysis would focus on the issued claim language and intrinsic record.

Which companies are challenging the Vyzulta patent estate?

The supplied information does not identify an ANDA filer, Paragraph IV notice letter, district-court complaint, or settlement agreement involving US 7,910,767. No specific challenger should be attributed without a verified litigation record.

The competitive set includes companies developing or marketing:

Generic latanoprost;
Generic bimatoprost;
Generic travoprost;
Generic unoprostone where available;
Fixed combinations containing timolol;
Investigational nitric-oxide-donating glaucoma agents.

These products are not automatically substitutes for latanoprostene bunod from a patent perspective. A conventional prostaglandin analog generally does not practice the nitrooxy derivative claims.

How strong is the patent estate?

The estate has different strengths by claim category.

Claim category	Relative strength
Broad compound genus	Broad scope, but greater validity exposure
Latanoprost-specific genus	Stronger commercial relevance and narrower construction
Named compounds	Potentially strongest if the commercial molecule is expressly claimed
Manufacturing process	Fact-dependent and difficult to detect
Topical composition	Depends on formulation limitations and later patents
Glaucoma method	Commercially relevant but vulnerable to divided-use and label-scrubbing issues
Timolol combination	Narrower market coverage and potentially easier design-around

The strongest practical protection usually comes from overlapping layers: an expressly claimed active ingredient, a formulation patent, a method-of-use patent, and regulatory exclusivity. US 7,910,767 is best viewed as the foundational active-ingredient layer rather than the complete Vyzulta protection package.

What generic launch scenarios exist?

Three scenarios are commercially plausible after the relevant foundational patents expire:

Immediate launch after clearance of all remaining listed patents.
This requires a successful Paragraph IV challenge, a negotiated license, or confirmation that no unexpired listed patent blocks launch.
At-risk launch after expiration of the foundational compound patent.
A generic may launch while litigating later formulation or method patents, accepting potential damages and injunctive risk.
Delayed launch until later patents expire or settle.
This is the lowest litigation-risk route but can materially defer market entry.

A generic could also pursue a design-around using a different prostaglandin derivative, nitrate placement, salt, concentration, or formulation. Whether that strategy works depends on the exact issued claims and the scope of later patents.

Key Takeaways

US 7,910,767 covers nitrooxy derivatives of prostaglandins, not merely unmodified prostaglandin drugs.
The broadest claim uses the structure R-X-Y-ONO2.
Latanoprost is expressly identified in dependent claim 5.
Claims 13 through 19 extend coverage to topical ophthalmic compositions, glaucoma treatment, and combination therapy.
Claim 11 covers selected manufacturing routes for producing the nitrate derivatives.
Latanoprostene bunod and Vyzulta are the principal commercial products associated with this technology.
The patent’s foundational term is tied to an early-2000s filing history and is materially older than later Vyzulta formulation and method patents.
Generic entry requires analysis of the complete Orange Book and litigation landscape, not US 7,910,767 alone.
The missing structures in claim 10 prevent a molecule-by-molecule comparison from the supplied text.

FAQs

Is latanoprostene bunod the same as latanoprost?

No. Latanoprostene bunod is a nitrooxy derivative of latanoprost designed to provide prostaglandin activity together with nitric-oxide-donor activity.

Does US 7,910,767 cover all nitric oxide glaucoma drugs?

No. It is limited to compounds incorporating the claimed prostaglandin residue, linker, nitrate group, and other structural limitations. A nitric oxide glaucoma drug without the claimed prostaglandin architecture would not fall within the claims merely because it lowers intraocular pressure.

Can a generic use the same active ingredient after US 7,910,767 expires?

Potentially, but only after evaluating later patents, Orange Book listings, regulatory exclusivity, formulation claims, method-of-use claims, and any litigation settlements.

Are timolol combinations covered by the patent?

Claim 19 specifically addresses mixtures containing a claimed prostaglandin-nitrooxy compound and timolol or a nitrooxy derivative of timolol. The exact scope depends on the incorporated limitations of claim 1.

Does FDA approval prove that the claimed compounds are patentable?

No. FDA approval addresses safety, efficacy, quality, and labeling. Patentability, validity, infringement, and enforceability are separate legal questions.

References

United States Patent No. 7,910,767, “Nitrooxy derivatives of prostaglandins and pharmaceutical compositions containing them,” issued March 22, 2011.
U.S. Food and Drug Administration. (2017). Vyzulta (latanoprostene bunod ophthalmic solution) prescribing information.
U.S. Food and Drug Administration. (2017). Drugs@FDA: Vyzulta, NDA 208254.
Nicox S.A. (Various years). Annual reports and regulatory disclosures concerning latanoprostene bunod and Vyzulta.
U.S. Food and Drug Administration. (2024). Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book.

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	04100001	Jan 5, 2004

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	047081	⤷ Start Trial
Argentina	098931	⤷ Start Trial
Australia	2004313688	⤷ Start Trial
Brazil	PI0418245	⤷ Start Trial
Canada	2551409	⤷ Start Trial
China	100469765	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Details for Patent: 7,910,767

Summary for Patent: 7,910,767