Details for Patent: 11,090,312

Which drugs does patent 11,090,312 protect, and when does it expire?

Patent 11,090,312 protects NATESTO and is included in one NDA.

This patent has two patent family members in one country.

Summary for Patent: 11,090,312

Title:	Methods of treating hypogonadism with transnasal testerosterone bio-adhesive gel formulations in male with allergic rhinitis, and methods for preventing an allergic rhinitis event
Abstract:	The present invention relates to methods of treating hypogonadism in a male subject through administering intranasally to the male subject an intranasal testosterone bio-adhesive gel formulation to deliver a therapeutically effective amount of testosterone. In particular, the testosterone therapy of the invention remains effective if an allergic rhinitis event occurs in the male during the treatment or when the male subject uses a topical nasal vasoconstrictor or a topical intranasal decongestant during the hypogonadism treatment. Further, the present invention relates to a method of preventing the occurrence of an allergic rhinitis event in a male, who is undergoing a hypogonadism treatment with an intranasal testosterone bio-adhesive gel. In certain embodiments, the intranasal testosterone bio-adhesive gel formulation according to the invention comprises 4.0% and 4.5% testosterone.
Inventor(s):	Natalia Tkachenko
Assignee:	Acerus Biopharma Inc
Application Number:	US16/905,610
Patent Claim Types: see list of patent claims	Use;

US Patent 11,090,312: Scope, Claim Construction, Expiration and Intranasal Testosterone Patent Landscape

US Patent 11,090,312 protects a narrow use of 4.5% intranasal testosterone gel in hypogonadal men who have symptomatic allergic, seasonal, or other rhinitis. The core commercial regimen is 11 mg of testosterone per nostril dose, administered three times daily, for approximately 33 mg per day. The patent also covers concurrent or sequential use of nasal decongestants, particularly oxymetazoline, without a clinically relevant reduction in testosterone absorption.

The patent is primarily a method-of-treatment patent. Its commercial relevance depends on whether a competing product or label instructs use in patients with rhinitis, uses the claimed dose and frequency, or combines intranasal testosterone with a vasoconstrictor or decongestant.

What does US Patent 11,090,312 protect?

The patent protects a specific treatment protocol rather than intranasal testosterone generally. Its principal limitations are:

Limitation	Claimed requirement
Patient	Male with hypogonadism or another testosterone-deficiency condition
Nasal condition	Symptomatic rhinitis, including allergic or seasonal rhinitis
Product	Testosterone gel containing about 4.5% testosterone by weight
Dose	About 11 mg testosterone per administration
Frequency	Three administrations daily
Total daily dose	About 33 mg testosterone
Administration	Divided between the left and right nostrils
Nasal symptoms	Congestion or symptomatic rhinitis is present
Decongestant	Oxymetazoline or another listed nasal vasoconstrictor/decongestant may be used
Pharmacokinetics	Testosterone absorption remains effective despite rhinitis or decongestant use
Vehicle	Certain claims require castor oil, oleoyl polyoxylglycerides and colloidal silicon dioxide
Clinical exposure	Certain claims require Cavg of 300 to 1,050 ng/dL and Cmax not exceeding 2,500 ng/dL

The patent does not claim every intranasal testosterone formulation, every patient with hypogonadism, or every dose of testosterone nasal gel.

How many independent claims does US 11,090,312 contain?

The supplied claim set contains four independent claims: claims 1, 2, 7 and 28.

Claim 1: Rhinitis plus oxymetazoline

Claim 1 requires:

1. A hypogonadal male.
2. Symptomatic rhinitis.
3. Daily intranasal administration of testosterone gel three times a day.
4. A serum 24-hour testosterone Cavg of at least 300 ng/dL.
5. Intranasal oxymetazoline administration.
6. A finding or limitation that oxymetazoline-induced vasoconstriction does not materially interfere with testosterone absorption.
7. A gel containing about 4.5% testosterone by weight.

This is the most specific oxymetazoline claim. A product used without oxymetazoline would not literally satisfy every limitation of claim 1, although other independent claims could still be relevant.

Claim 2: Congested nose and 33 mg daily dose

Claim 2 requires:

• Symptomatic seasonal or allergic rhinitis;
• Nasal congestion;
• 4.5% testosterone gel;
• Administration into each nostril;
• Three daily administrations;
• Approximately 11 mg per administration;
• Approximately 5.5 mg in each nostril;
• Approximately 33 mg total testosterone per day; and
• No relevant reduction in absorption caused by the congested nose.

Claim 2 is important because it does not expressly require oxymetazoline. A competing product or treatment protocol could implicate claim 2 based solely on use in patients with symptomatic congestion.

Claim 7: Broader decongestant combination claim

Claim 7 covers intranasal testosterone treatment in a male with symptomatic allergic or seasonal rhinitis. It requires:

• Approximately 11 mg testosterone three times daily;
• Approximately 33 mg testosterone daily;
• Serum testosterone between approximately 300 and 1,050 ng/dL;
• A 4.5% testosterone gel; and
• Concurrent use with a nasal vasoconstrictor or nasal decongestant that does not interfere with absorption.

Compared with claim 1, claim 7 is broader as to the decongestant because it covers a class of agents rather than requiring oxymetazoline specifically.

Claim 28: Metered-pump and dispensing instructions

Claim 28 is directed to a product-use system involving:

• An 11-gram metered-dose pump;
• 60 pump actuations;
• One pump into each nostril;
• Three daily dosing events;
• 5.5 mg testosterone per nostril;
• Approximately 33 mg daily;
• Treatment of congenital or acquired primary or hypogonadotropic hypogonadism; and
• Effective treatment whether rhinitis is untreated or treated with a nasal decongestant.

This claim creates a potential infringement issue for a product label, patient instructions or promotional materials that specify the same pump configuration and dosing regimen.

What formulations are protected by US 11,090,312?

The formulation limitations appear in claims 1, 2, 7, 12 through 16, 21 through 27 and 28.

The most commercially specific formulation is recited in claim 27:

Component	Claimed amount
Castor oil	87.5%
Oleoyl polyoxylglycerides	4.0%
Colloidal silicon dioxide	4.0%
Testosterone	Approximately 4.5%

The stated percentages total 100%. The formulation therefore appears to define the marketed 4.5% testosterone nasal gel vehicle rather than a broad generic nasal dosage form.

Vehicle limitations

The dependent claims identify:

• Castor oil as the oil-based solvent;
• Oleoyl polyoxylglyceride as the wetting agent; and
• Colloidal silicon dioxide as the viscosity-increasing agent.

These limitations may create separate formulation infringement exposure if a competing product uses the same composition or a formulation materially equivalent to it. They also create design-around opportunities. A competitor could attempt to use a different oil, surfactant or rheology modifier, although that would not eliminate method claims based on the 4.5% gel, dose, frequency and rhinitis limitations.

Diffusion-rate limitations

Claims 21 through 26 recite a testosterone diffusion rate of:

• Approximately 28 to 100 slope/mgT%;
• Approximately 30 to 95 slope/mgT%; or
• Approximately 28 to 35 slope/mgT%.

These parameters could be difficult to assess from ordinary product labeling. Enforcement would likely require formulation testing under the patent's specified analytical method and interpretation of the “slope/mgT%” measurement.

Does the patent cover Natesto?

The claimed regimen closely corresponds to Natesto, the FDA-approved testosterone nasal gel product. Natesto contains 4.5% testosterone and is administered as one pump actuation into each nostril three times daily. Each actuation into one nostril delivers approximately 5.5 mg testosterone, producing approximately 33 mg of testosterone per day when both nostrils are dosed at each administration [1].

The overlap is substantial:

Natesto characteristic	US 11,090,312 claim characteristic
4.5% testosterone nasal gel	Expressly recited
5.5 mg per nostril	Expressly recited
11 mg per dosing event	Expressly recited
Three times daily	Expressly recited
Approximately 33 mg daily	Expressly recited
Metered-dose pump	Expressly recited in claim 28
Hypogonadism	Expressly recited
300 to 1,050 ng/dL target range	Expressly recited in claims 7, 17 and 18

The distinguishing subject matter is the rhinitis setting and the finding that congestion or a nasal decongestant does not materially impair testosterone absorption.

What is the Orange Book status of US 11,090,312?

A patent's inclusion in the FDA Orange Book is separate from its validity and enforceability. Orange Book listing generally depends on whether the patent claims the approved drug, a method of using the approved drug, or another FDA-recognized product-related subject matter [2].

US 11,090,312 is a method-of-treatment patent focused on use of intranasal testosterone in patients with rhinitis and on use with nasal decongestants. Its Orange Book significance therefore depends on the FDA listing record for the relevant testosterone nasal gel product and the patent holder's listing submission.

The practical distinction is:

• If listed, an ANDA applicant may need to address it through a Paragraph IV certification or a section viii statement, depending on the scope of the proposed labeling.
• If not listed, the patent may still be asserted in district court or under other patent remedies, but it would not create the same statutory ANDA litigation framework.
• A method-of-use patent can be avoided through a label that omits the patented rhinitis indication or combination use, subject to induced-infringement and label-content analysis.

The patent number alone does not establish current Orange Book listing, delisting or the exact applicable reference-listed drug entry.

When does US 11,090,312 lose exclusivity?

The patent issued on August 17, 2021. Its enforceable expiration date is determined by the earliest effective nonprovisional priority date, any patent-term adjustment, any patent-term extension and any terminal disclaimer recorded by the USPTO.

A statutory patent term generally runs 20 years from the earliest effective nonprovisional filing date, not 20 years from issuance [3]. The claims supplied do not identify the earliest nonprovisional application, the patent-family priority chain, patent-term adjustment or terminal disclaimer. Accordingly, the issue date does not establish the expiration date.

The commercial exclusivity timeline should be separated into four elements:

Exclusivity element	Relevance
FDA approval exclusivity	Natesto was approved in 2014; any original approval exclusivity is no longer the principal barrier
Orange Book patents	May delay or complicate ANDA approval depending on listing and certification
US 11,090,312	Focuses on rhinitis-related use and decongestant-compatible administration
Other formulation or composition patents	May provide broader protection for intranasal testosterone independent of rhinitis

The patent should therefore be analyzed as one layer in the Natesto estate, not as the entire exclusivity position.

What Paragraph IV challenges could target this patent?

An ANDA applicant could challenge the patent through:

1. Paragraph IV certification that the patent is invalid;
2. Paragraph IV certification that the proposed product does not infringe;
3. A section viii statement carving out patented rhinitis or decongestant use, if FDA accepts the carve-out; or
4. A combination of a non-infringing label and a factual non-infringement position.

Likely invalidity theories

The strongest potential invalidity theories would be:

• Anticipation by prior intranasal testosterone dosing disclosures;
• Obviousness based on known 4.5% testosterone nasal gel, standard rhinitis treatment and ordinary use of oxymetazoline;
• Lack of written description for the specific combination of symptomatic rhinitis, decongestant use and preserved testosterone absorption;
• Lack of enablement for the claimed range of vasoconstrictors and decongestants;
• Indefiniteness of “does not impact ... to any relevant extent” and “does not interfere”; and
• Indefiniteness or lack of clarity concerning “slope/mgT %” diffusion measurements.

Likely non-infringement theories

A generic or follow-on sponsor could argue that:

• Its product does not contain approximately 4.5% testosterone;
• It uses a different dose or frequency;
• Its label does not direct treatment of symptomatic rhinitis;
• Its label excludes use during nasal congestion;
• It does not recommend oxymetazoline or another listed decongestant;
• Its formulation lacks the claimed vehicle components; or
• It does not use the claimed metered-dose pump configuration.

The label strategy is significant because induced infringement of method claims generally depends on affirmative instructions or encouragement to perform the claimed steps. A product sold for ordinary hypogonadism treatment without rhinitis-related instructions presents a different risk profile from a product marketed for use during congestion or with oxymetazoline.

How strong is the patent estate for intranasal testosterone?

US 11,090,312 has moderate technical breadth but potentially strong commercial relevance for the specific Natesto regimen.

Patent characteristic	Assessment
Product concentration	Narrow, approximately 4.5%
Dose	Narrow, approximately 11 mg per administration
Frequency	Narrow, three times daily
Disease	Narrow, hypogonadism
Patient condition	Narrow, symptomatic rhinitis or congestion
Decongestant use	Broad in claim 7; oxymetazoline-specific in claims 1 and 10-11
Vehicle	Narrow in dependent claims
Pharmacokinetics	Adds measurable clinical limitations but may complicate proof
Design-around potential	Meaningful through dose, formulation, label and use restrictions
Commercial blocking potential	High if a competitor copies the Natesto regimen and labels use during rhinitis

The estate is stronger as a regulatory and labeling barrier than as a broad composition patent. A competitor can potentially avoid several claims by changing the vehicle or omitting rhinitis-related instructions. It becomes more difficult to avoid the patent if the competing product is the same 4.5% gel, uses the same 11 mg three-times-daily regimen and is promoted for patients who remain symptomatic with allergic or seasonal rhinitis.

What patent litigation or settlement agreements affect US 11,090,312?

The supplied information does not identify a district-court case, PTAB proceeding, settlement agreement or license specifically involving US 11,090,312. A complete litigation assessment requires docket-level review of:

• PACER;
• USPTO Patent Center;
• PTAB proceedings;
• FDA Orange Book records;
• ANDA litigation complaints; and
• Public licensing and settlement disclosures.

No litigation or settlement conclusion should be drawn solely from the claim language.

Which companies are challenging intranasal testosterone exclusivity?

The relevant competitive groups are:

Generic testosterone manufacturers

Potential ANDA sponsors would likely evaluate a label carve-out, Paragraph IV certification or both. Their principal concerns would be the formulation patents, the dosing method and the commercial feasibility of excluding rhinitis-related use.

Transdermal testosterone manufacturers

Products such as gels, patches and injections compete with intranasal testosterone but generally do not practice the patented intranasal method. Their competitive effect is therapeutic substitution rather than direct patent infringement.

Other nasal drug-delivery developers

A company developing an alternative intranasal testosterone product could design around the patent through a different concentration, dose, delivery device, vehicle or dosing frequency. It would still face possible blocking rights under earlier Natesto formulation and composition patents.

What generic launch scenarios exist?

Scenario 1: Label carve-out

A generic applicant omits rhinitis and decongestant-related instructions. This may reduce risk under claims 1, 2, 7 and 28, but it does not automatically eliminate infringement if the proposed label or promotional conduct encourages the claimed use.

Scenario 2: Formulation design-around

A competitor uses a non-castor-oil vehicle or changes the wetting and viscosity agents. This may avoid claims 12 through 16 and 27, while leaving method claims exposed if the dose, concentration, frequency and rhinitis use remain the same.

Scenario 3: Dose or frequency change

A product using a different daily dose or fewer than three daily administrations may avoid several claims. The regulatory and clinical consequences would be substantial because Natesto's dosing regimen is central to its approved product profile.

Scenario 4: Direct Paragraph IV litigation

A generic applicant challenges validity or infringement. The central disputes would likely concern obviousness, the meaning of “relevant” absorption interference, the predictability of testosterone absorption during rhinitis and the relationship between prior art on nasal decongestants and intranasal testosterone.

How does US 11,090,312 compare with broader testosterone patents?

Patent category	Typical scope	Relationship to US 11,090,312
Testosterone composition patents	Gel composition, concentration and excipients	May block formulation substitution
Intranasal delivery patents	Nasal administration of testosterone	May be broader than the rhinitis-specific claims
Method-of-use patents	Treatment of hypogonadism	Usually broader disease coverage but may lack nasal limitations
Device patents	Pump, actuator and dose metering	Relevant to claim 28 and product replication
Pharmacokinetic patents	Cavg, Cmax or exposure profile	Overlap with claims 1, 7, 17-20
Rhinitis-combination patents	Testosterone plus decongestant	Closest technical match to US 11,090,312

What manufacturing and geographic barriers remain?

The patent is enforceable only in the United States. Parallel rights may exist in Canada, Europe, Australia and other jurisdictions, but US 11,090,312 does not establish foreign protection.

Manufacturing barriers may arise from:

• Reproducing the 4.5% testosterone formulation;
• Achieving consistent 5.5 mg delivery per nostril;
• Maintaining dose uniformity through 60 pump actuations;
• Controlling viscosity and spray or gel distribution;
• Demonstrating the claimed diffusion-rate parameters; and
• Establishing pharmacokinetic performance during rhinitis and decongestant use.

A manufacturer can avoid literal formulation limitations while still facing regulatory equivalence, bioequivalence and device-performance requirements.

Key Takeaways

• US 11,090,312 is a narrow method patent centered on intranasal testosterone treatment during symptomatic rhinitis.
• The commercial regimen is approximately 11 mg per administration, three times daily, for approximately 33 mg per day.
• Claims 1 and 10-11 focus on oxymetazoline; claim 7 reaches a broader group of nasal vasoconstrictors and decongestants.
• Claims 12-16 and 27 protect vehicle components including castor oil, oleoyl polyoxylglycerides and colloidal silicon dioxide.
• Claim 28 adds an 11-gram, 60-actuation metered-pump configuration.
• The patent closely tracks the marketed Natesto dosing system and formulation.
• The principal generic strategies are a label carve-out, formulation redesign, altered dosing and Paragraph IV litigation.
• Patent expiration cannot be calculated from the issue date alone. The controlling date depends on the full priority chain, patent-term adjustment and any terminal disclaimer.
• The patent's greatest commercial value is as a use and labeling barrier for a Natesto-like product, not as a broad monopoly over all testosterone nasal products.

FAQs about US Patent 11,090,312

Does US 11,090,312 cover testosterone injections or transdermal testosterone?

No. The supplied claims require intranasal administration of testosterone gel. Injections, patches and ordinary transdermal gels generally fall outside the express administration limitations.

Does using oxymetazoline automatically infringe the patent?

No. Infringement requires satisfaction of all limitations of an applicable claim. For claim 1, the patient, rhinitis, testosterone concentration, dosing schedule, oxymetazoline use and absorption limitations must all be met.

Can a generic avoid the patent by changing the nasal gel vehicle?

Potentially. A vehicle change may avoid the dependent formulation claims, but it may not avoid claims based on concentration, dose, frequency, rhinitis and decongestant use.

Is the 33 mg daily dose the only dose covered?

No. It is central to claims 2 through 7 and 28, but claim 1 is framed around an effective total daily dose producing a Cavg of at least 300 ng/dL. The exact scope depends on claim construction and the limitations of the asserted claim.

Does the patent protect use of testosterone nasal gel in every patient with a stuffy nose?

No. The claims require a male patient with hypogonadism or a testosterone-deficiency condition and specific intranasal testosterone dosing. Several claims also require allergic, seasonal or symptomatic rhinitis and a particular concentration or regimen.

References

1. Food and Drug Administration. (2014). Natesto (testosterone) nasal gel prescribing information. U.S. Department of Health and Human Services.

2. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. U.S. Department of Health and Human Services.

3. United States Patent and Trademark Office. (2024). Manual of Patent Examining Procedure, Chapter 2700: Patent term. U.S. Department of Commerce.

4. United States Patent and Trademark Office. (2021). US Patent No. 11,090,312. U.S. Department of Commerce.

Drugs Protected by US Patent 11,090,312

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Acerus	NATESTO	testosterone	GEL, METERED;NASAL	205488-001	May 28, 2014		RX	Yes	Yes	11,090,312					NASAL ADMINISTRATION OF A TESTOSTERONE GEL TO A PATIENT TO TREAT THE PATIENT FOR A CONDITION ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE

International Family Members for US Patent 11,090,312

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
World Intellectual Property Organization (WIPO)	2014080282
World Intellectual Property Organization (WIPO)	2014080283