Details for Patent: 9,814,705

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Summary for Patent: 9,814,705

Title:	Intranasal spray device containing pharmaceutical composition
Abstract:	An intranasal spray device contains a composition for the intranasal delivery of fentanyl or a pharmaceutically acceptable salt thereof to an animal includes an aqueous solution of fentanyl or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable additive selected from (i) a pectin and (ii) a poloxamer and chitosan or a salt or derivative thereof; provided that when the composition comprises a pectin it is substantially free of divalent metal ions; and which, in comparison to a simple aqueous solution of fentanyl administered intranasally at the same dose, provides a peak plasma concentration of fentanyl (Cmax) that is from 10 to 80% of that achieved using a simple aqueous solution of fentanyl administered intranasally at an identical fentanyl dose. A method for treating or managing pain by intranasally administering the composition is also disclosed.
Inventor(s):	Peter James Watts, Jonathan David Castile, William Columbus Ian Lafferty, Alan Smith
Assignee:	Btcp Pharma LLC , Assertio Holdings Inc
Application Number:	US14/747,289
Patent Claim Types: see list of patent claims	Composition; Formulation; Delivery; Device;

US Patent 9,814,705: Fentanyl Pectin Nasal Spray Patent Scope, Expiration, and Patent Landscape

US Patent No. 9,814,705 protects a fentanyl intranasal spray device containing a low-esterification pectin formulation designed to moderate fentanyl absorption. The independent claims require a combination of device, formulation, physicochemical, pharmacokinetic, and therapeutic limitations. A competing product generally must satisfy all limitations of at least one asserted claim to create literal infringement risk.

The patent’s central commercial coverage is a pectin-containing fentanyl nasal spray with a 5-to-30-minute Tmax and a Cmax of 10% to 80% of an equivalent simple aqueous fentanyl solution. The apparent nominal patent term runs to 2027, subject to any applicable patent-term adjustment or extension.

What patent protects US 9,814,705?

US 9,814,705 protects an intranasal spray device containing a fentanyl formulation with the following core characteristics:

Required element	Claim 1 requirement
Product type	Intranasal spray device
Active ingredient	Fentanyl or a pharmaceutically acceptable salt
Fentanyl concentration	0.05 mg/mL to 30 mg/mL, expressed as fentanyl base
Matrix or absorption modifier	Pectin
Pectin esterification	Degree of esterification, or DE, of 7% to 30%
Divalent metals	Composition substantially free of divalent metal ions
Pharmacokinetics	Cmax equal to 10% to 80% of a simple aqueous fentanyl comparator
Tmax	5 to 30 minutes
Use	Single-dose treatment or management of pain

The claims are directed to a combination product rather than to fentanyl, pectin, or nasal delivery in isolation. The patent does not broadly cover every fentanyl nasal spray. It targets a particular formulation and delivery profile implemented through a spray device.

How broad is the independent claim coverage?

Claim 1 is broad in some compositional respects but narrow in its pharmacokinetic limitations.

The claim covers:

• Fentanyl base and pharmaceutically acceptable fentanyl salts.
• A broad fentanyl concentration range of 0.05 to 30 mg/mL.
• Pectin with a DE value from 7% to 30%.
• Unit-dose and multidose devices.
• Devices using a bottle, pump, and actuator.
• A practical dose volume producing a specified Cmax and Tmax.

The claim does not expressly require:

• Fentanyl citrate.
• A particular bottle material.
• A particular pump manufacturer.
• A particular spray plume or droplet-size distribution.
• A specific commercial dose such as 100, 400, or 800 micrograms.
• A specific preservative.
• A particular pectin source or molecular weight.
• A named brand or indication.

The pharmacokinetic limitations materially narrow the claim. A formulation that contains low-DE pectin but produces a Cmax outside the 10%-to-80% range, or a Tmax outside 5 to 30 minutes, may fall outside the literal scope of claim 1.

What do claims 2 through 24 add?

Claims 2 through 24 create narrower fallback positions around the device, dose, pectin, osmolality, pH, and concentration.

Device claims

Claims 2 and 3 cover a unit-dose device, including a bottle, pump, and actuator. Claims 4 and 5 cover a multidose device with the same general components.

Claim 6 narrows the delivery volume to 0.01 mL to 0.15 mL per actuation. This limitation is commercially relevant because fentanyl nasal sprays typically use small spray volumes to reduce runoff, swallowing, and variability in nasal deposition.

Dose claims

Claim 7 covers 10 to 5,000 micrograms of fentanyl per dosage unit. Claim 8 narrows the upper limit to 3,000 micrograms.

The text supplied for claim 7 states "5000 pig," which is evidently a transcription error for 5,000 micrograms. Claim interpretation should rely on the issued patent and prosecution record rather than the transcribed text.

Pectin claims

Claim 9 requires a DE value of 10% to 25%. Claim 10 narrows the range to 15% to 25%.

These claims are narrower than claim 1 and may be more commercially significant if the marketed formulation uses pectin within those ranges. A formulation using pectin with a DE above 30% or below 7% would not satisfy the express DE limitation.

Salt and pectin concentration

Claims 11 and 12 cover a pharmaceutically acceptable fentanyl salt and specifically fentanyl citrate.

Claim 13 requires 5 to 25 mg/mL of pectin. This limitation is central to the likely commercial formulation because it links pectin concentration to the claimed nasal absorption profile.

Divalent metal exclusion

Claim 14 requires the formulation to be at least 99% free of divalent metal ions. This is materially narrower than claim 1’s "substantially free" standard but may create an evidentiary issue. The parties would need to define the relevant analytical method, concentration basis, and whether trace ions introduced by excipients, water, packaging, or manufacturing are included.

Osmolality and pH

Claims 15 through 19 cover osmolality from 0.2 to 0.8 osmol/kg, with narrower ranges of 0.2 to 0.4 and 0.25 to 0.35 osmol/kg. The formulation may use a non-metal-ion osmolality adjuster, including:

• Mannitol
• Sorbitol
• Dextrose
• Sucrose
• Trehalose

Claims 20 through 22 cover pH from 3 to 6, with narrower ranges of 3.2 to 5.5 and 3.4 to 5.0.

Claims 23 and 24 narrow fentanyl concentration to 0.1 to 20 mg/mL and 0.2 to 16 mg/mL.

What is the scope of independent claim 25?

Claim 25 is the most commercially specific formulation claim. It requires a device containing an aqueous composition with:

Parameter	Claim 25 range
Fentanyl concentration	0.1 to 20 mg/mL
Pectin concentration	5 to 25 mg/mL
Pectin DE	10% to 25%
pH	3.4 to 5.0
Osmolality	0.20 to 0.40 osmol/kg
Divalent metal ions	Substantially absent
Cmax	10% to 80% of simple aqueous fentanyl
Tmax	5 to 30 minutes
Administration	Intranasal
Use	Pain treatment or management

The supplied text states "0.20 osmol/mg to 0.40 osmol/kg." The first unit is internally inconsistent and appears to be a drafting or transcription error. The scientifically coherent unit is osmol/kg.

Claim 25 is potentially stronger for enforcement against a formulation that closely follows the commercial product design. It is also easier to design around by changing one or more of the pectin DE, pectin concentration, pH, osmolality, or pharmacokinetic parameters.

What formulations are protected by US 9,814,705?

The patent principally protects an aqueous fentanyl-pectin formulation in which pectin acts as a nasal absorption-modifying polymer. The formulation architecture has four technical objectives:

1. Deliver fentanyl through the nasal mucosa.
2. Use low-DE pectin to alter residence time and absorption.
3. Avoid divalent metal ions that may interact with pectin and alter gelation or viscosity.
4. Produce rapid but moderated systemic fentanyl exposure.

The strongest formulation coverage is concentrated around the following combination:

• Fentanyl citrate or another fentanyl salt.
• Fentanyl at 0.2 to 16 mg/mL.
• Pectin at 5 to 25 mg/mL.
• Pectin DE of 15% to 25%.
• pH of 3.4 to 5.0.
• Osmolality of 0.25 to 0.35 osmol/kg.
• A dose volume of 0.01 to 0.15 mL.

A formulation using a different mucoadhesive polymer, such as carbomer, chitosan, hyaluronic acid, or a high-DE pectin, would not literally satisfy the pectin limitation. It could still raise an issue under the doctrine of equivalents, depending on the prosecution history and the reason for selecting low-DE pectin.

Does the patent cover fentanyl citrate?

Yes. Claim 12 expressly identifies fentanyl citrate as a covered pharmaceutically acceptable fentanyl salt.

The broader claims also cover fentanyl base and other pharmaceutically acceptable salts, provided the remaining limitations are met. Salt selection therefore does not, by itself, avoid the patent.

A product using fentanyl hydrochloride, fentanyl citrate, or another salt would still need to be assessed against:

• Fentanyl concentration expressed as fentanyl base.
• Pectin DE.
• Pectin concentration.
• Absence of divalent metals.
• pH and osmolality, where applicable.
• Cmax and Tmax.
• Device and dose-volume limitations.

When does US 9,814,705 lose exclusivity?

The patent’s nominal term is generally calculated from the earliest effective nonprovisional filing date in its priority chain. Public patent records identify the patent as part of the Archimedes fentanyl nasal-spray patent family and indicate a nominal expiration in 2027, subject to patent-term adjustment or any applicable patent-term extension. The exact enforceable expiration date should be determined from the USPTO patent-term data and any FDA patent-term extension record.

Event	Date or status
Patent issued	November 14, 2017
Patent number	US 9,814,705 B2
Technology	Fentanyl-pectin intranasal spray
Nominal term	Generally expected to end in 2027
PTA/PTE	Must be confirmed from USPTO and FDA records
Post-expiration status	Claims cannot ordinarily be enforced after expiration

Expiration of US 9,814,705 would not eliminate other barriers. Related continuation patents, formulation patents, regulatory exclusivity, controlled-substance requirements, manufacturing patents, trademarks, and trade secrets may affect market entry.

What is the Orange Book status of US 9,814,705?

An Orange Book listing is product-specific. A patent may be enforceable under ordinary patent law without being listed in the FDA Orange Book, while an Orange Book-listed patent can create a statutory notice and litigation pathway for an ANDA applicant.

For a fentanyl nasal spray, the relevant regulatory questions are:

• Whether the reference drug is approved under an NDA.
• Whether US 9,814,705 is listed against that NDA.
• Whether the listing covers the drug substance, drug product, or method of use.
• Whether an ANDA applicant must certify to the patent.
• Whether the patent remains listed on the relevant FDA publication date.

The claims supplied are product and formulation claims. They are not conventional method-of-use claims directed only to a disease indication. If listed, they would likely be treated as drug-product or formulation/device claims rather than pure use claims.

The FDA Orange Book should be read together with the patent itself because an Orange Book entry does not expand claim scope. The patent controls the legal boundaries of infringement; the Orange Book controls the regulatory certification and notice consequences. (FDA, 2024a)

What Paragraph IV challenges could arise?

An ANDA applicant seeking approval for a therapeutically equivalent fentanyl nasal spray could consider a Paragraph IV certification if it contends that the patent is invalid, unenforceable, or not infringed.

The principal Paragraph IV theories would be:

Non-infringement

A generic applicant could design around one or more limitations by using:

• Pectin with DE above 30% or below 7%.
• A non-pectin mucoadhesive.
• A pectin concentration below 5 mg/mL or above 25 mg/mL for claim 25.
• pH outside the claimed ranges.
• Osmolality outside 0.20 to 0.40 osmol/kg.
• A delivery volume outside 0.01 to 0.15 mL.
• A PK profile with Cmax above 80% or below 10% of the comparator.
• Tmax outside 5 to 30 minutes.

The PK limitations create both a defense and a litigation risk. They may be difficult to establish before launch because Cmax and Tmax depend on dose, patient population, sampling schedule, nasal condition, device performance, and comparator design.

Invalidity

Potential validity challenges include:

• Lack of written description for the full concentration, pectin, pH, osmolality, and PK combinations.
• Lack of enablement across the full claim breadth.
• Obviousness based on earlier fentanyl nasal sprays, pectin-containing nasal formulations, and known mucoadhesive delivery systems.
• Indefiniteness involving "practical dose volume," "substantially free," and the comparator "simple aqueous solution."
• Indefiniteness or correction issues arising from inconsistent osmolality units in claim 25.

The strongest validity arguments would likely focus on the interaction between the formulation ranges and the required PK outcome. The patent does not merely claim ingredients. It claims a result measured against a comparator. The specification and prosecution record would determine whether the examples support the full claimed combinations.

How strong is the patent estate?

US 9,814,705 has moderate-to-strong blocking value against a close copy of the claimed fentanyl-pectin product, but weaker coverage against a materially different nasal delivery system.

Risk factor	Assessment
Exact commercial copy	High
Same fentanyl salt and low-DE pectin	High
Same pH, osmolality, and dose volume	High
Different mucoadhesive polymer	Lower literal risk
Pectin outside DE range	Potential design-around
Different PK profile	Potential design-around, but testing risk
Device-only substitution	Usually insufficient if formulation remains within claims
Generic using same reference formulation	High litigation risk
Generic with reformulated nasal system	Moderate technical and regulatory risk

The estate is strongest where formulation, device, and pharmacokinetic data converge. It is less effective as a broad monopoly over intranasal fentanyl.

Which companies are relevant to the patent landscape?

Archimedes and associated product interests

The patent family is associated with the Archimedes fentanyl nasal-spray program. Archimedes developed fentanyl nasal products using pectin-based delivery technology, including PecFent and related commercial programs. Ownership, licensing, and marketing rights have changed across jurisdictions and over time, so the current patent owner, product sponsor, and commercial licensee must be distinguished.

Competing fentanyl nasal products

The principal competitive product is Lazanda, a fentanyl citrate nasal spray approved by the FDA for breakthrough cancer pain in opioid-tolerant adults. PecFent is a related pectin-based fentanyl nasal spray marketed in certain non-U.S. jurisdictions. FDA labeling for Lazanda identifies fentanyl citrate nasal spray as the active product and provides the approved dose and administration framework. (FDA, 2024b)

Other intranasal fentanyl products may use different formulations, devices, or regulatory pathways. They should not be presumed to infringe US 9,814,705 without comparing their pectin and PK characteristics.

What litigation or settlement issues affect the patent?

A patent-specific litigation conclusion requires review of the complete federal docket, PTAB records, USPTO prosecution history, and FDA certification records. The claim set alone does not establish whether a Paragraph IV notice, ANDA suit, inter partes review, post-grant review, or settlement exists.

The principal litigation issues would likely concern:

• Whether an accused product contains pectin within the claimed DE range.
• Whether trace divalent ions defeat the "substantially free" limitation.
• Whether Cmax and Tmax are measured using the required comparator.
• Whether the accused product is a "device containing" the composition.
• Whether the claimed PK limitations are definite and enabled.
• Whether prosecution amendments created estoppel against equivalents.

Any settlement could include a licensed entry date, supply arrangement, authorized-generic commitment, or restrictions on formulation changes. Those commercial terms would not be apparent from the issued claims.

What generic launch scenarios exist?

Scenario 1: Same formulation

A generic uses fentanyl citrate, low-DE pectin, comparable pH and osmolality, and the same type of spray device. This is the highest-risk scenario and could trigger a Paragraph IV suit if the patent is listed and unexpired.

Scenario 2: Formulation design-around

A generic changes the pectin DE, replaces pectin, or moves pH and osmolality outside the narrower claims. This reduces literal infringement risk but requires new pharmaceutical development, bioequivalence work, device testing, and potentially a different regulatory strategy.

Scenario 3: PK-based design-around

A generic produces a Cmax outside the claimed 10%-to-80% range or Tmax outside 5 to 30 minutes. This strategy is technically possible but commercially unattractive if it compromises safety, onset, tolerability, or therapeutic performance.

Scenario 4: Post-expiration entry

A manufacturer waits until patent expiration and relies on an ANDA or other applicable FDA pathway. This avoids patent litigation risk from US 9,814,705 but does not eliminate other listed patents or regulatory barriers.

What manufacturing and IP barriers remain?

The formulation claims are only one part of the entry barrier. A competitor would also need to reproduce or independently develop:

• Low-DE pectin with controlled batch characteristics.
• Stable fentanyl aqueous solutions.
• Low-volume nasal spray performance.
• Pump-dose uniformity.
• Microbiological control and preservative compatibility.
• Control of pH and osmolality.
• Consistent nasal deposition.
• Fentanyl containment and controlled-substance security.
• Packaging that limits adsorption, extractables, and leachables.
• Commercial-scale filling and device assembly.

Trade secrets may protect pectin specifications, mixing order, filtration, filling parameters, pump selection, and release testing even after the patent expires.

How does US 9,814,705 compare with broad fentanyl patents?

US 9,814,705 is narrower than a patent claiming fentanyl generally and narrower than a patent claiming all nasal opioid delivery. Its value comes from layering limitations:

1. A specific opioid.
2. A specific polymer class.
3. A narrow pectin DE range.
4. A metal-ion exclusion.
5. A spray device.
6. A defined dose-volume framework.
7. A specified PK outcome.

That structure makes the patent more defensible against a close commercial copy but easier to design around than a broad composition-of-matter patent.

Key Takeaways

• US 9,814,705 covers a fentanyl intranasal spray device using low-DE pectin.
• Claim 1 requires both formulation limitations and a specific Cmax/Tmax profile.
• Claim 25 is the most commercially focused formulation claim.
• Fentanyl citrate is expressly covered.
• Unit-dose and multidose spray devices are both included.
• Claims 6 through 24 narrow protection around volume, dose, pectin DE, pectin concentration, pH, osmolality, and metal-ion content.
• The patent’s nominal term is expected to end in 2027, subject to USPTO patent-term adjustment or FDA patent-term extension.
• The strongest infringement risk concerns a close copy of the fentanyl-pectin formulation and spray-device architecture.
• A different polymer, pectin DE, pH, osmolality, or PK profile may provide a design-around.
• The principal commercial competitors are fentanyl nasal-spray products such as Lazanda and PecFent.
• Orange Book listing, Paragraph IV exposure, and any settlement rights must be evaluated separately from the patent claim language.

FAQs About US Patent 9,814,705

Does US 9,814,705 cover all fentanyl nasal sprays?

No. It requires pectin with a specified DE range, a substantially metal-free composition, and defined pharmacokinetic results. A non-pectin fentanyl nasal spray may fall outside the literal claims.

Is fentanyl citrate specifically protected?

Yes. Claim 12 expressly recites fentanyl citrate. The broader claims also cover other pharmaceutically acceptable fentanyl salts if the remaining limitations are met.

Can changing the spray pump avoid US 9,814,705?

Not necessarily. Claims 1 and 25 are directed to a device containing the composition. Changing the pump alone may not avoid infringement if the replacement device still satisfies the claimed formulation, dose, and PK limitations.

Does a pectin formulation infringe if it has a different pectin DE?

Potentially not under literal infringement if the DE is outside the claimed range. The result depends on which claim is asserted, measurement methods, claim construction, and any doctrine-of-equivalents analysis.

Is US 9,814,705 a method-of-use patent?

No. The claims are primarily device and formulation claims. They include treatment or management of pain as part of the claimed administration context, but they are not limited to a conventional method-of-treatment claim alone.

References

1. U.S. Food and Drug Administration. (2024a). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book

2. U.S. Food and Drug Administration. (2024b). Lazanda prescribing information. FDA.

3. U.S. Patent and Trademark Office. (2017). U.S. Patent No. 9,814,705, intranasal fentanyl spray device and composition. Washington, DC: U.S. Department of Commerce.

4. Google Patents. (n.d.). US9814705B2: Patent record and related applications. https://patents.google.com/patent/US9814705B2/en

5. European Medicines Agency. (n.d.). PecFent product information. EMA.

Drugs Protected by US Patent 9,814,705

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

Foreign Priority and PCT Information for Patent: 9,814,705

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
United Kingdom	0300531.1	Jan 10, 2003

International Family Members for US Patent 9,814,705

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	1635783		C300653	Netherlands
European Patent Office	1635783		CA 2014 00016	Denmark
European Patent Office	1635783		300653	Netherlands
European Patent Office	1635783		122014000024	Germany