# United States Patent 10,206,932: Claim Scope, Bijuva Coverage, Patent Expiration and Generic Entry Risk

US Patent No. 10,206,932 protects methods of treating menopausal vasomotor symptoms with oral estradiol/progesterone compositions formulated in a medium-chain oil. The patent is directed to pharmacokinetic outcomes as well as formulation structure. Its commercial significance is closely tied to TherapeuticsMD's Bijuva product, an FDA-approved oral capsule containing estradiol and progesterone for menopausal women with a uterus.

The strongest practical coverage is for products that combine:

Estradiol at 0.25 mg, 0.5 mg or 1 mg per dosage unit.
Progesterone, including 50 mg or 100 mg strengths.
At least 80% solubilized estradiol.
Suspended progesterone.
A medium-chain oil based predominantly on C6-C12 fatty-acid esters.
Complete incorporation of the estradiol and progesterone into the oil.
Plasma estradiol exposure within specified AUC or Cmax ranges.

Public patent and FDA records identify US 10,206,932 as a key patent associated with the estradiol/progesterone product platform marketed as Bijuva. The patent has an expiration date in 2032, subject to any applicable patent-term adjustment or extension reflected in the official patent and FDA records.[1][2]

What does US Patent 10,206,932 protect?

The patent protects a treatment method rather than merely a composition. The independent claims require administration to a subject with vasomotor symptoms associated with estrogen deficiency.

The claims cover three principal estradiol dose levels:

Claim group	Estradiol dose	Express progesterone combinations
Claims 1-7, 17	About 0.25 mg	About 50 mg progesterone
Claims 8-11, 15, 18-19	About 0.5 mg	About 50 mg or 100 mg progesterone
Claims 12-14, 16, 20	About 1 mg	About 100 mg progesterone

The composition limitations apply across the claimed dose levels:

Limitation	Required feature
Estradiol state	At least 80% of estradiol is solubilized
Progesterone state	Progesterone includes suspended progesterone
Vehicle	Medium-chain oil
Fatty-acid profile	Predominantly C6-C12 fatty-acid esters
Oil loading	Entire amount of estradiol and progesterone is present in the oil
Therapeutic use	Treatment of estrogen-deficiency-associated vasomotor symptoms
Pharmacokinetics	One or more specified estradiol exposure parameters

The patent therefore combines product architecture, dosage, therapeutic indication and pharmacokinetic performance in a single claim framework.

How are the independent claims structured?

Claims 1, 8 and 12 are the principal independent claims. They differ primarily by estradiol dose.

Claim 1: 0.25 mg estradiol

Claim 1 covers administration of a composition containing about 0.25 mg estradiol. At least 80% must be solubilized. The progesterone must include suspended progesterone, and both hormones must be contained in the medium-chain oil.

The administered composition must produce either:

Estradiol AUC(0-t) of 140.3733 to 219.3333 pg·hr/mL; or
Estradiol Cmax of 6.4790 to 10.1235 pg/mL.

Claim 17 narrows this claim to approximately 50 mg progesterone.

Claim 8: 0.5 mg estradiol

Claim 8 covers about 0.5 mg estradiol with the same formulation architecture. The estradiol pharmacokinetic ranges are approximately double those in claim 1:

Estradiol AUC(0-t): 280.7467 to 438.6667 pg·hr/mL; or
Estradiol Cmax: 12.9580 to 20.2469 pg/mL.

Claims 18 and 19 specifically cover 0.5 mg estradiol with approximately 50 mg or 100 mg progesterone.

Claim 12: 1 mg estradiol

Claim 12 covers about 1 mg estradiol. The estradiol exposure ranges are approximately double those in claim 8:

Estradiol AUC(0-t): 561.4933 to 877.3333 pg·hr/mL; or
Estradiol Cmax: 25.9161 to 40.4939 pg/mL.

Claim 20 narrows the combination to approximately 1 mg estradiol and 100 mg progesterone.

What formulation characteristics are required?

The formulation limitations are central to infringement analysis.

Solubilized estradiol

At least 80% of the estradiol must be solubilized in the finished composition. This limitation distinguishes the claimed composition from a formulation in which estradiol is primarily suspended or otherwise present as undissolved solid.

The 80% threshold creates a measurable product-quality limitation. A generic or competing product could seek to avoid literal infringement by using a materially different estradiol physical state, although the resulting formulation would still need to be assessed under the doctrine of equivalents.

Suspended progesterone

The claims require progesterone that includes suspended progesterone. The claim does not require all progesterone to be suspended. A formulation containing both dissolved and suspended progesterone may fall within the literal scope if the suspended component is present and the other limitations are met.

This feature is commercially important because the claimed formulation uses different physical states for the two hormones: predominantly solubilized estradiol and at least some suspended progesterone.

Medium-chain oil

The vehicle must contain medium-chain fatty-acid esters of glycerol, polyethylene glycol, propylene glycol, or mixtures of these materials. The fatty-acid esters must be predominantly derived from C6-C12 fatty acids.

This language is broad enough to encompass common pharmaceutical lipid excipients, including medium-chain triglyceride-type and related ester systems. The claim is not limited to a single named excipient, trade name or manufacturing supplier.

Complete hormone loading into the oil

The claims state that the entire amount of estradiol and progesterone in the composition is present in the oil. This limitation links the active ingredients to the lipid vehicle and excludes formulations in which a portion of either hormone is held in a separate phase or excipient system.

What pharmacokinetic parameters are claimed?

The patent uses pharmacokinetic ranges as claim limitations. These parameters are not merely examples of performance. They are express elements of the claimed methods.

Estradiol parameters

Estradiol dose	AUC(0-t), pg·hr/mL	Cmax, pg/mL
0.25 mg	140.3733-219.3333	6.4790-10.1235
0.5 mg	280.7467-438.6667	12.9580-20.2469
1 mg	561.4933-877.3333	25.9161-40.4939

The ranges for the 0.5 mg and 1 mg strengths are approximately twofold and fourfold, respectively, relative to the 0.25 mg ranges. This structure supports a dose-proportional pharmacokinetic theory.

Progesterone parameters

The dependent claims add the following progesterone ranges:

Associated dose group	AUC(0-t), ng·hr/mL	Cmax, ng/mL
Lower progesterone exposure	24.0174-37.5272	17.8444-27.8819
Higher progesterone exposure	48.0348-75.0543	35.6889-55.7639

Claims 5, 11, 15 and 16 apply these parameters to the relevant estradiol-dose claims. Claim 15 is drafted as depending from claim 8 but recites the lower progesterone exposure range also used in claim 5. That drafting issue may affect claim-construction arguments, but it does not eliminate the issued claim from the patent record.

Estrone and total estrone parameters

The patent also claims metabolic exposure to estrone and total estrone.

For the 0.25 mg estradiol group, the claims recite:

Estrone AUC(0-t): 909.6091 to 1,421.2642 pg·hr/mL.
Estrone Cmax: 42.6549 to 66.6483 pg/mL.
Total estrone AUC(0-t): 20.1752 to 31.5238 ng·hr/mL.
Total estrone Cmax: 3.5429 to 5.5358 ng/mL.

The 0.5 mg and 1 mg claims use proportionally higher ranges. These limitations may complicate design-around strategies because a competitor could alter formulation or dose in an attempt to move outside the stated pharmacokinetic windows.

What is the commercial product associated with the patent?

The patent is commercially relevant to Bijuva, marketed by TherapeuticsMD and later subject to commercial transactions involving the product and related assets. Bijuva is an oral softgel containing estradiol and progesterone. FDA approved Bijuva in October 2018 for the treatment of moderate to severe vasomotor symptoms associated with menopause in women with a uterus.[3]

The FDA-approved strengths are:

Product	Estradiol	Progesterone	Dosage form
Bijuva	0.5 mg	100 mg	Oral softgel capsule
Bijuva	1 mg	100 mg	Oral softgel capsule

The 0.5 mg/100 mg and 1 mg/100 mg commercial strengths map directly to claims 19 and 20. The 0.25 mg/50 mg and 0.5 mg/50 mg combinations appear in the patent claims but are not the principal FDA-approved Bijuva strengths identified in the current prescribing information.[3]

What is the Orange Book status of US 10,206,932?

US 10,206,932 is associated with the Bijuva product patent listing in FDA Orange Book materials. The relevant listing is a method-of-use or product-related patent entry tied to the approved estradiol/progesterone product and its menopausal vasomotor-symptom indication.[2]

The practical consequences are:

An ANDA applicant referencing Bijuva must address the listed patent.
A Paragraph IV certification would allege that the patent is invalid, unenforceable or not infringed.
A Paragraph III certification would defer approval until patent expiration.
A section viii statement could carve out a patented use if the applicant does not seek approval for the protected indication, although the feasibility of a carve-out depends on the remaining approved labeling and the precise listed use.

Because the claims require treatment of vasomotor symptoms in an estrogen-deficient subject, a generic seeking the same indication would face a direct method-of-use issue. A product-label carve-out could reduce risk only if the proposed label avoids the patented use and the product is not otherwise promoted for that use.

When does US Patent 10,206,932 lose exclusivity?

The patent's listed expiration is in 2032, with June 17, 2032 commonly identified as the expiration date for the relevant patent family. The date reflects a 20-year term measured from the applicable nonprovisional filing chain, subject to any patent-term adjustment.[1][2]

The exclusivity timeline is:

Event	Date or period
Earliest priority period	2011
Relevant patent-family filing period	2012 and later continuation filings
Patent grant	February 19, 2019
Bijuva FDA approval	October 2018
Patent expiration	Approximately June 17, 2032
Potential generic entry	Before expiration only through a successful challenge, settlement, license or other statutory pathway

FDA regulatory exclusivity for Bijuva is separate from patent exclusivity. The Hatch-Waxman exclusivity period does not extend to 2032. The commercial barrier after regulatory exclusivity is therefore primarily patent-based.

How strong is the patent estate for Bijuva?

The patent has meaningful coverage because it does not depend solely on one broad composition claim. It combines several potentially overlapping infringement theories:

Composition structure.
Hormone physical state.
Lipid excipient class.
Estradiol dose.
Progesterone dose.
Menopausal treatment indication.
Estradiol pharmacokinetics.
Progesterone pharmacokinetics.
Estrone and total estrone pharmacokinetics.

Its principal weakness is claim complexity. An accused product must satisfy multiple formulation and pharmacokinetic limitations. A generic applicant could challenge one or more elements by arguing that:

Less than 80% of estradiol is solubilized.
Progesterone is not suspended.
The vehicle does not contain predominantly C6-C12 fatty-acid esters.
Not all active ingredients are present in the oil.
The administered product does not produce the claimed pharmacokinetic ranges.
The proposed label does not instruct treatment of the claimed condition.

The pharmacokinetic limitations may be particularly vulnerable to noninfringement arguments because measured AUC and Cmax depend on study design, sampling intervals, analytical methods, patient population and fed or fasted conditions. The patent holder, however, could argue that a product designed to match the reference product's bioavailability will predictably fall within the claimed ranges.

What generic entry risks exist?

The greatest generic risk is a direct Bijuva-equivalent product containing 0.5 mg estradiol and 100 mg progesterone or 1 mg estradiol and 100 mg progesterone in a similar oil-based softgel.

High-risk scenario

A generic has:

The same approved strengths.
A lipid vehicle based on medium-chain fatty-acid esters.
Predominantly solubilized estradiol.
Some suspended progesterone.
A label for menopausal vasomotor symptoms.
Pharmacokinetic performance comparable to Bijuva.

This product could implicate claims 8, 12, 19 and 20, along with dependent pharmacokinetic claims.

Moderate-risk scenario

A generic uses the same actives and indication but changes the excipient system or physical state of one hormone. Risk would depend on laboratory characterization, bioequivalence data and whether the pharmacokinetic ranges remain within the claims.

Lower-risk scenario

A product uses different hormone doses, a non-lipid delivery system, a different route of administration or a label that excludes the patented vasomotor-symptom indication. Patent risk would remain fact-specific, but the principal literal claim elements would be easier to avoid.

Are biosimilars relevant to this patent?

No. Bijuva contains chemically synthesized small-molecule hormones, estradiol and progesterone. It is regulated through the NDA pathway, not as a biologic under the Public Health Service Act. The relevant competitive threat is an ANDA generic, not a biosimilar.

This distinction affects litigation and exclusivity analysis. Generic applicants may rely on Bijuva's safety and efficacy findings through an abbreviated application, subject to bioequivalence and patent certification requirements.

Which companies are challenging the patent?

No specific successful Paragraph IV challenge or final invalidity decision affecting US 10,206,932 is established by the supplied claim text. Public Orange Book and FDA records should be reviewed for current certifications, ANDA litigation and any patent-term changes. A patent number alone does not establish that a Paragraph IV notice has been served or that litigation is pending.

The absence of a confirmed challenge in the patent information supplied means the present commercial risk assessment should focus on the patent's remaining term, Bijuva's market size and the feasibility of formulation or labeling design-arounds.

What patent litigation and settlement issues matter?

A Paragraph IV notice against an Orange Book-listed Bijuva patent could trigger a 30-month FDA approval stay under Hatch-Waxman, subject to statutory exceptions and litigation developments.[4] The principal litigation questions would likely include:

Whether the generic's estradiol is at least 80% solubilized.
Whether the generic contains suspended progesterone.
Whether the vehicle is predominantly composed of C6-C12 fatty-acid esters.
Whether the full active-ingredient amount is present in the oil.
Whether pharmacokinetic ranges are claim limitations that can be assessed from ANDA data.
Whether the generic label induces infringement of the patented menopausal indication.
Whether any continuation or related patent adds overlapping formulation or method claims.

A settlement could permit an agreed launch date before June 2032. The economic value of such a settlement would depend on Bijuva sales, the number of potential ANDA applicants, authorized-generic rights and any license terms.

How does this patent compare with competing menopause products?

Bijuva is distinct from estrogen-only products and from separately administered estrogen plus progesterone regimens.

Product category	Estradiol and progesterone in one dosage unit?	Typical patent risk from US 10,206,932
Bijuva-equivalent oral softgel	Yes	High
Generic estradiol-only tablet	No	Low under this patent
Oral micronized progesterone alone	No	Low under this patent
Separate estradiol and progesterone products	No single combined oil composition	Generally lower, unless conduct induces patented use
Transdermal estradiol plus oral progesterone	Different route and product architecture	Lower literal risk
Compounded estradiol/progesterone capsule	Potentially similar composition	Fact-specific; commercial distribution and labeling raise separate regulatory issues

The patent is therefore strongest against fixed-dose combination products that replicate the Bijuva formulation and indication. It is less directly relevant to products that separate the hormones or use a non-oral route.

What manufacturing and IP barriers exist?

The principal manufacturing barrier is reproducible control of hormone physical state. A manufacturer must control:

Estradiol solubilization percentage.
Progesterone suspension characteristics.
Particle-size distribution.
Uniformity of dose in the oil vehicle.
Medium-chain ester composition.
Content uniformity during encapsulation.
Stability over the labeled shelf life.
Bioavailability under the intended dosing conditions.

A design-around that changes the oil vehicle may create new development and regulatory burdens. A formulation that avoids suspended progesterone or reduces estradiol solubilization could also alter dissolution, absorption and clinical performance.

The patent's formulation limitations may therefore create practical barriers even where a theoretical noninfringing formulation is available.

Key Takeaways

US 10,206,932 is a method patent directed to estradiol/progesterone treatment for menopausal vasomotor symptoms.
The patent requires a medium-chain C6-C12 oil system, at least 80% solubilized estradiol and suspended progesterone.
The commercial Bijuva strengths of 0.5 mg/100 mg and 1 mg/100 mg align with claims 19 and 20.
Pharmacokinetic ranges for estradiol, progesterone, estrone and total estrone are express claim limitations.
The patent is associated with Orange Book-listed Bijuva protection and has an expiration date approximately June 17, 2032.
The principal competitive threat is an ANDA generic, not a biosimilar.
A Bijuva-equivalent generic would face the highest risk if it copies the oil vehicle, hormone physical states, approved doses and vasomotor-symptom indication.
The principal design-around options are changing the vehicle, altering hormone physical state, separating the hormones, changing the route or carving out the patented use.
Any Paragraph IV challenge would likely focus on formulation characterization, pharmacokinetic proof, claim construction, enablement, obviousness and induced infringement.

FAQs About US Patent 10,206,932

Does US 10,206,932 cover Bijuva 1 mg/100 mg?

Yes. Claim 20 expressly recites about 1 mg estradiol and about 100 mg progesterone, subject to the underlying formulation and treatment limitations of claim 12.

Does the patent cover estradiol-only hormone therapy?

No. The claims require both estradiol and progesterone in the claimed oil-based composition.

Can a generic avoid the patent by changing only the capsule shell?

Not necessarily. Changing the shell would leave the claimed active ingredients, vehicle, physical-state and pharmacokinetic limitations unchanged.

Does the patent cover transdermal estradiol patches?

No. The claims are directed to a pharmaceutical composition in which both hormones are present in a medium-chain oil. A transdermal patch would ordinarily use a different delivery system.

Is a 0.25 mg estradiol and 50 mg progesterone product expressly claimed?

Yes. Claim 17 narrows claim 1 to about 0.25 mg estradiol and about 50 mg progesterone.

References

United States Patent and Trademark Office. (2019). U.S. Patent No. 10,206,932, pharmaceutical compositions and methods of use thereof.
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book.
U.S. Food and Drug Administration. (2018). Bijuva prescribing information. TherapeuticsMD, Inc.
U.S. Food and Drug Administration. (2023). Abbreviated new drug application process and patent certifications.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Mayne Pharma	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-002	Dec 28, 2021		RX	Yes	No	10,206,932	⤷ Start Trial				TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS	⤷ Start Trial
Mayne Pharma	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-001	Oct 28, 2018		RX	Yes	Yes	10,206,932	⤷ Start Trial				TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS	⤷ 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
Argentina	100562	⤷ Start Trial
Australia	2015264003	⤷ Start Trial
Canada	2947767	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

Summary for Patent: 10,206,932