Details for Patent: 9,949,985

Which drugs does patent 9,949,985 protect, and when does it expire?

Patent 9,949,985 protects TLANDO and is included in one NDA.

This patent has one patent family member in one country.

Summary for Patent: 9,949,985

Title:	High-strength testosterone undecanoate compositions
Abstract:	The present disclosure is drawn to pharmaceutical compositions and oral dosage capsules containing testosterone undecanoate, as well as related methods. The capsule includes a capsule shell and a capsule fill. The capsule fill can include a solubilizer and about 14 wt % to about 35 wt % testosterone undecanoate based on the total capsule fill. The oral dosage capsule is such that when a single oral administration to a male subject of one or more capsules with a total testosterone undecanoate daily dose of about 350 mg to about 650 mg it provides a ratio of serum testosterone Cmax to serum testosterone Cave of about 2.7 or less. In yet another embodiment, a method for providing a serum concentration of testosterone within a target serum testosterone concentration Cave range for a male subject is provided.
Inventor(s):	Chandrashekar Giliyar, Basawaraj Chickmath, Nachiappan Chidambaram, Mahesh V. Patel, Srinivansan Venkateshwaran
Assignee:	Lipocine Inc
Application Number:	US15/818,697
Patent Claim Types: see list of patent claims	Use; Composition; Dosage form;

US Patent 9,949,985: Claim Scope, Jatenzo Coverage, and Oral Testosterone Undecanoate Patent Landscape

US Patent 9,949,985 covers a method of treating male hypogonadism by administering oral testosterone undecanoate at approximately 430-460 mg per day, generally in a twice-daily regimen with food, to achieve serum testosterone of approximately 300-1,100 ng/dL. The claims are directed primarily to dosing, formulation composition, administration frequency, capsule dosage forms, and pharmacokinetic outcomes. They do not broadly claim testosterone undecanoate as a chemical compound.

The patent is associated with the oral testosterone undecanoate product Jatenzo, marketed by Clarus Therapeutics. The principal commercial risk is an abbreviated new drug application or other competing oral testosterone product that practices every limitation of an asserted claim, particularly the 430-460 mg daily dose and twice-daily, two-capsule-per-dose regimen.

What does US Patent 9,949,985 cover?

US Patent 9,949,985 covers replacement therapy in a male with deficient or absent endogenous testosterone. Independent claims 1, 15, and 22 define three related but distinct claim strategies:

Claim	Core limitation	Practical scope
1	Oral pharmaceutical composition containing 14-35 wt% testosterone undecanoate; 430-460 mg/day; serum testosterone of 300-1,100 ng/dL	Broadest formulation-and-dose claim
15	Testosterone undecanoate composition containing 50-86 wt% solubilizer; 430-460 mg/day; serum testosterone of 300-1,100 ng/dL	Solubilizer-focused formulation claim
22	Two unit dosage forms twice daily with a meal; 430-460 mg/day; serum testosterone of 300-1,100 ng/dL	Administration-regimen claim

The claims are method claims. An accused product or treatment protocol must be used in the claimed manner. A product containing testosterone undecanoate is not automatically within the claims unless the relevant dosing, formulation, patient, and serum-level limitations are also met.

What are the essential elements of claim 1?

Claim 1 requires all of the following:

1. A male patient.
2. A condition associated with deficiency or absence of endogenous testosterone.
3. Oral administration.
4. A pharmaceutical composition containing approximately 14-35 wt% testosterone undecanoate.
5. A carrier.
6. A daily testosterone undecanoate dose of approximately 430-460 mg.
7. Serum testosterone in the range of approximately 300-1,100 ng/dL.

The phrase "serum testosterone Cave" in the supplied claim text appears to be a transcription or OCR error for "serum testosterone Cavg," meaning average serum testosterone concentration. The patent specification and prosecution history should control the precise interpretation.

How narrow is the 430-460 mg testosterone undecanoate limitation?

The 430-460 mg daily range is a material limitation, not a general reference to testosterone replacement therapy. A regimen delivering 400 mg or 480 mg per day would fall outside the literal numerical range, subject to claim-construction issues and potential doctrine-of-equivalents arguments.

Claim 13 narrows the dose to approximately 450 mg per day and specifies four unit dosage forms:

• Two unit dosage forms in the morning.
• Two unit dosage forms in the evening.
• Approximately 450 mg total testosterone undecanoate per day.

Claim 22 uses substantially the same commercial regimen but adds administration with a meal. Claim 24 narrows claim 22 to approximately 450 mg per day.

This structure creates several infringement pathways:

Regimen	Potential relevance
430-460 mg once daily	Potentially within claim 1 or 15, but may not satisfy twice-daily dependent claims
450 mg once daily	Potentially within independent claims if all other limitations are met
225 mg twice daily	Potentially within claims 11, 17, or 22 if delivered as the required unit dosage forms
Two capsules morning and two capsules evening	Directly aligned with claims 13, 21, and 22
Dose adjusted below 430 mg/day	Potential design-around position, subject to actual patient dosing and equivalents
Dose above 460 mg/day	Outside the literal stated range, subject to the same legal qualification

What formulation components are protected?

The patent does not claim one single mandatory carrier system across all claims. Instead, dependent claims identify a broad group of carrier components.

Solubilizers and dispersants

Claim 2 requires a carrier containing a solubilizer and a dispersant. Claim 15 independently requires a composition containing 50-86 wt% solubilizer. Claims 25 and 26 separately require a solubilizer and dispersant under claim 22.

The solubilizer limitation is commercially important because oral testosterone undecanoate has poor aqueous solubility and depends on lipid-based or self-emulsifying delivery systems. A competing formulation using a materially different excipient system may avoid claims that require a solubilizer, although claim 1 does not expressly require one.

Lipid-based carrier components

Claims 4-8 and 18 identify:

• Monoglycerides.
• Diglycerides.
• Triglycerides.
• Fatty acids.
• Medium-chain monoglycerides and diglycerides.

Claim 18 permits one or more of the listed components. The claim language therefore reaches multiple lipid formulation architectures rather than a single named excipient.

Tocopherols, surfactants, and solidifying agents

Claims 9, 10, 19, and 20 cover:

• Tocopherols.
• Hydrophilic surfactants.
• Solidifying agents.

These limitations may become relevant to softgel, capsule, tablet, or other oral dosage forms depending on how the formulation is manufactured and characterized.

Dissolution profile

Claim 14 requires that at least 5% of the testosterone undecanoate remain undissolved and at least 35% be dissolved in the carrier. This is a formulation-state limitation. It may require analytical testing under the conditions specified in the patent or interpreted through the specification and prosecution history.

A formulation could avoid claim 14 while still implicating claim 1, because claim 14 is dependent and adds a separate dissolution requirement.

Does US Patent 9,949,985 claim Jatenzo itself?

The patent appears to cover the administration method and formulation profile used by Jatenzo, but the claims do not simply claim the Jatenzo brand or the active ingredient without qualification.

Jatenzo contains oral testosterone undecanoate and is administered with food. The FDA-approved labeling identifies a starting regimen of 237 mg twice daily with meals, equivalent to 474 mg of testosterone undecanoate per day, with titration based on serum testosterone measurements. The supplied claims use approximately 430-460 mg per day, which raises a potentially important issue: the exact approved Jatenzo dosing language, product strength, and claim construction must be compared against the patent's examples and Orange Book listing. [2]

The commercial regimen described in claims 13, 21, and 22 is more specific than a generic oral testosterone undecanoate product. It requires two unit dosage forms in the morning and two in the evening. A product supplied in different strengths or administered at a different frequency may have a noninfringement position even if it uses the same active ingredient.

What is the Orange Book status of US Patent 9,949,985?

US Patent 9,949,985 is associated with the Jatenzo patent estate and has been listed in FDA Orange Book materials for the product. Orange Book relevance depends on the patent's listing information, including the applicable use code and whether the listed patent covers an approved method of use rather than the drug substance or drug product. [1]

For an ANDA applicant, the key questions are:

Orange Book issue	Relevance
Patent listed for Jatenzo	May require a Paragraph IV certification or a later-expiry certification
Method-of-use listing	The ANDA label and proposed dosing instructions become central
Use code	Determines whether the listed patent reads on the proposed indication or administration method
30-month stay	May arise if the patent holder timely files an infringement action after a Paragraph IV notice
Carve-out possibility	A labeling carve-out may be available if the patented method can be omitted without undermining approval

The patent's reported expiration date is April 6, 2031, subject to the official USPTO patent-term calculation, any patent-term adjustment, terminal disclaimer, and Orange Book data in effect for the relevant product. [3][4]

When does US Patent 9,949,985 lose exclusivity?

The patent is generally identified with an April 6, 2031 expiration date. That date is distinct from FDA regulatory exclusivity.

Exclusivity type	Approximate status
US patent term	Reported expiration: April 6, 2031
Jatenzo new chemical entity exclusivity	Five-year period from FDA approval in 2019, subject to statutory timing
FDA three-year exclusivity	May apply to certain approved changes supported by clinical investigations, but does not create the same broad protection as NCE exclusivity
Pediatric exclusivity	Any six-month extension must be confirmed in FDA records
Generic entry	May occur before patent expiry if a Paragraph IV challenge succeeds, settles with an agreed entry date, or avoids the patent claims

FDA approval of Jatenzo occurred in March 2019. NCE exclusivity therefore did not independently block an ANDA indefinitely. After the regulatory exclusivity period, patent disputes and settlement terms become the primary barriers to generic entry. [2]

What Paragraph IV challenges affect the patent?

A Paragraph IV certification asserts that a listed patent is invalid, unenforceable, or not infringed. The supplied claims alone do not establish whether a particular ANDA applicant has filed a Paragraph IV certification against US 9,949,985.

The most likely litigation theories against this type of patent would include:

• Lack of written description for the claimed serum range.
• Enablement of the full 430-460 mg dose range across the claimed carrier systems.
• Obviousness based on prior oral testosterone undecanoate formulations, dosing studies, and food-effect data.
• Indefiniteness involving "about," serum testosterone averaging, and dissolution measurements.
• Noninfringement based on a different dose, dosing frequency, carrier, unit dosage form, or label.
• Lack of infringement where a patient, rather than the manufacturer, independently alters the regimen.

For a method patent, the ANDA label is critical. If the proposed label instructs administration of the claimed dose with the claimed frequency and food conditions, the patent holder may have a stronger induced-infringement theory. A label that omits or carves out the patented method may reduce that risk, although actual marketing conduct remains relevant.

How strong is the patent estate for oral testosterone undecanoate?

US 9,949,985 has meaningful commercial value because it combines three protection layers:

1. A defined daily dose.
2. A serum testosterone target range.
3. A formulation and administration protocol.

The estate is stronger against a direct copy of the Jatenzo regimen than against all oral testosterone undecanoate products. Its principal vulnerabilities are the relatively specific numerical ranges and the dependence on clinical and pharmacokinetic facts that may vary between patients.

Strengths

• Covers a commercially relevant oral testosterone replacement regimen.
• Uses a serum testosterone endpoint tied to therapeutic performance.
• Includes formulation claims covering common lipid excipients.
• Includes capsule and twice-daily administration limitations.
• Can be asserted through ANDA label analysis and inducement theories.

Vulnerabilities

• The independent claims require a relatively narrow daily dose.
• Serum testosterone may vary based on patient, meal, adherence, and assay conditions.
• Some carrier limitations appear in dependent claims only.
• Prior art in oral lipid formulations and testosterone replacement may support obviousness arguments.
• A competitor may select a different dose strength, dosing frequency, formulation, or label instruction.

How does this patent compare with competing oral testosterone products?

Jatenzo competes with other oral testosterone undecanoate products, including Tlando and Kyzatrex. Each product has its own FDA-approved dosing instructions, formulation technology, patent family, and Orange Book listing profile.

Product	Sponsor	Active ingredient	Key differentiation
Jatenzo	Clarus Therapeutics	Testosterone undecanoate	Oral softgel regimen with food; dose titration based on serum testosterone
Tlando	Lipocine	Testosterone undecanoate	Oral testosterone replacement using a distinct formulation and dosing program
Kyzatrex	Marius Pharmaceuticals	Testosterone undecanoate	Oral softgel product with its own formulation and dosing instructions

The existence of competing approved products does not establish freedom to operate. A competing product may avoid US 9,949,985 through a different formulation or dosing protocol while still encountering separate patents covering composition, manufacturing, pharmacokinetics, or method of use.

Biosimilar risk is not material in the same way as it is for a biologic. Testosterone undecanoate is a chemically defined small molecule. Competitive entry would ordinarily proceed through an ANDA or, for a materially different product, a 505(b)(2) application rather than the biosimilar pathway. [2]

What manufacturing and geographic barriers remain?

The patent is a US patent and directly controls conduct in the United States. Separate national patent rights may affect Canada, Europe, Japan, and other markets, but US 9,949,985 has no direct extraterritorial effect.

Manufacturing risk may arise from:

• Preparing a high-load testosterone undecanoate lipid formulation.
• Maintaining the claimed dissolved and undissolved fractions.
• Producing uniform capsule fills.
• Achieving consistent bioavailability under fed conditions.
• Demonstrating reproducible serum testosterone exposure.
• Maintaining stability of lipid excipients and testosterone undecanoate.

A manufacturer can avoid a formulation dependent claim without avoiding claim 1 if the alternative still contains 14-35 wt% testosterone undecanoate, delivers 430-460 mg per day, and produces the claimed serum range. Conversely, a formulation outside the claimed composition range may still face claim 15 or claim 22 if it uses the claimed solubilizer or administration protocol.

What generic launch scenarios exist?

Launch after patent expiry

A generic company may launch after April 6, 2031, assuming no later-expiring patent or regulatory exclusivity blocks approval.

Paragraph IV launch

An ANDA applicant may challenge the patent before expiry. The principal arguments would likely focus on obviousness, enablement, indefiniteness, and whether the proposed label requires the patented regimen.

Label carve-out

A generic may seek approval without the patented method of use if FDA labeling rules permit removal of the relevant dosing instructions. This route is more difficult where the patented method overlaps materially with the product's principal approved indication and ordinary use.

Noninfringing formulation or dose

A competitor may use a different testosterone undecanoate concentration, daily dose, dosing frequency, capsule configuration, or carrier system. The design-around must be assessed claim by claim because the independent claims use different limitations.

Key Takeaways

• US Patent 9,949,985 is a method-of-treatment patent for oral testosterone undecanoate replacement therapy.
• The central numerical limitation is approximately 430-460 mg of testosterone undecanoate per day.
• The claims target serum testosterone of approximately 300-1,100 ng/dL.
• Claim 22 is particularly aligned with a twice-daily, with-food regimen using two unit dosage forms per administration.
• Dependent claims add solubilizers, dispersants, lipid excipients, tocopherols, hydrophilic surfactants, solidifying agents, capsules, and dissolution characteristics.
• The reported patent expiration date is April 6, 2031.
• The patent is more difficult to design around when a competitor copies the dose, capsule count, twice-daily schedule, meal instruction, and formulation architecture.
• Tlando and Kyzatrex create competitive pressure but do not eliminate the need for product-specific claim and Orange Book analysis.
• Biosimilar substitution is not the relevant entry pathway because testosterone undecanoate is a small-molecule active ingredient.
• Paragraph IV risk depends heavily on the ANDA label, proposed dosing regimen, formulation composition, and the patent holder's litigation response.

FAQs

Is testosterone undecanoate itself patented by US 9,949,985?

No. The supplied claims cover methods of administering oral testosterone undecanoate with specified doses, formulations, and serum testosterone outcomes. They do not broadly claim the molecule itself.

Can a 430 mg daily testosterone undecanoate regimen infringe?

It may. A 430 mg regimen is within the stated range, but infringement also requires the applicable composition, carrier, patient, oral-administration, and serum-level limitations.

Does a once-daily product avoid the patent?

It may avoid claims requiring twice-daily administration, such as claims 11, 17, and 22. It may still implicate independent claims 1 or 15 if all their limitations are met.

Are Tlando and Kyzatrex automatically covered by this patent?

No. Coverage depends on each product's formulation, dose, administration instructions, and serum testosterone profile. Separate patents may apply to those products.

What is the main legal risk for a Jatenzo generic?

The main risk is an ANDA label that instructs use of approximately 430-460 mg of testosterone undecanoate per day, in capsule form, twice daily with meals, while producing the claimed serum testosterone range.

References

1. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.accessdata.fda.gov/scripts/cder/ob/
2. U.S. Food and Drug Administration. (2019). Jatenzo prescribing information. Clarus Therapeutics.
3. United States Patent and Trademark Office. (2018). U.S. Patent No. 9,949,985: Oral testosterone undecanoate formulations and methods of use.
4. United States Patent and Trademark Office. (n.d.). Patent Center: U.S. Patent No. 9,949,985. https://patentcenter.uspto.gov/

Drugs Protected by US Patent 9,949,985

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Verity	TLANDO	testosterone undecanoate	CAPSULE;ORAL	208088-001	Mar 28, 2022		RX	Yes	Yes	9,949,985					TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED).

International Family Members for US Patent 9,949,985

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
World Intellectual Property Organization (WIPO)	2012075081