Details for Patent: 10,675,288

Which drugs does patent 10,675,288 protect, and when does it expire?

Patent 10,675,288 protects BIJUVA and is included in one NDA.

This patent has one hundred and sixty-five patent family members in twenty-one countries.

Summary for Patent: 10,675,288

Title:	Natural combination hormone replacement formulations and therapies
Abstract:	Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.
Inventor(s):	Brian A. Bernick, Janice Louise Cacace, Peter H. R. Persicaner, Neda Irani, Julia M. Amadio
Assignee:	TherapeuticsMD Inc
Application Number:	US15/090,493
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,675,288
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

United States Patent 10,675,288: Scope, Claim Architecture, and Competitive Patent Landscape (Based on Provided Claims Only)

What is the core invention in US 10,675,288?

US 10,675,288 is directed to capsule-based combination hormone therapy for estrogen-deficient states in females, built around a specific lipid/oil matrix that solubilizes estradiol and supports a mixed progesterone system (suspended micronized progesterone plus solubilized progesterone).

The claims repeatedly require the same “composition geometry”:

• Estradiol: 0.17 to 0.35 wt % solubilized estradiol
• Progesterone: 30 to 35 wt % progesterone, where progesterone is both
  • suspended micronized progesterone, and
  • solubilized progesterone
• Oil phase: 55 to 75 wt % of an oil that is predominantly:
  • medium chain fatty acid mono- and diglycerides (esters of C6 to C12 fatty acids)
• Surfactant: 0.5 to 10 wt % nonionic surfactant
• Crucial physical placement requirement: the solubilized estradiol, suspended micronized progesterone, and solubilized progesterone are present in the oil

The independent claim 1 establishes the method framework, while dependent claims add narrower specifications (oil carbon range, estradiol solubilization extent, surfactant identity, capsule type, release behavior, and indication-specific selections).

What do the independent claims cover?

Two independent claim blocks appear from the provided set:

Claim 1 (indication-generic method)

A method of treating an estrogen-deficient state in a female subject in need, via administering a capsule containing the specified formulation.

Key structural elements of claim 1:

• Administration format: “a capsule containing an effective amount”
• Dose-form composition constraints: estradiol wt%, progesterone wt%, oil wt%, surfactant wt%
• Phase/particle system constraints:
  • estradiol is solubilized
  • progesterone is a blend of suspended micronized progesterone plus solubilized progesterone
  • all three progesterone/estradiol forms must be present in the oil
• Oil chemical identity constraint: predominantly medium chain mono-/diglyceride esters C6 to C12
• Nonionic surfactant constraint: 0.5 to 10 wt %

Claim 13 (vasomotor symptom of menopause method)

Claim 13 repeats the full formulation requirement, but the treatment target is narrowed to vasomotor symptoms of menopause.

The claim language is structurally the same as claim 1, but with an indication-specific method scope:

• “treating a vasomotor symptom of menopause”
• same ranges and oil/surfactant/solubilization requirements

Claim 16 (vulvovaginal atrophy method)

Claim 16 narrows again, but for vulvovaginal atrophy.

It also uses the same composition core:

• estradiol 0.17 to 0.35 wt% solubilized
• progesterone 30 to 35 wt% split between suspended micronized and solubilized
• oil 55 to 75 wt% medium chain mono-/diglycerides esters predominantly C6 to C12
• nonionic surfactant 0.5 to 10 wt%
• all forms present in the oil

How do the dependent claims narrow scope (what design-arounds are blocked)?

The dependent claims create a ladder of enforceability. Any competing formulation must avoid every required narrowing element if it intends to escape the literal scope of a particular dependent claim, but it may still fall within claim 1 if the core composition remains the same.

Oil carbon range narrowing (claims 2-4)

• Claim 2: oil predominantly medium chain mono-/diglycerides esters of C6 to C10
• Claim 3: oil predominantly esters of C8 to C12
• Claim 4: oil predominantly esters of C8 to C10

These are alternative narrower oil definitions attached to claim 1. A product using:

• predominantly C8 to C10 medium chain mono-/diglyceride esters is explicitly within claim 4 (and also within claim 1 if it still satisfies C6 to C12).

Estradiol solubilization extent (claim 5)

• Claim 5: “at least 90% of the total estradiol is solubilized.”

This blocks certain partial-solubilization designs. If a competitor keeps estradiol “solubilized” but does not reach ≥90%, it may aim to fall outside claim 5 while still meeting claim 1 if claim 1 only requires “solubilized estradiol” (not the 90% quantification). Still, many infringement arguments will hinge on whether the formulation’s estradiol state is measured as “solubilized” and quantified.

Surfactant identity (claim 6)

• Claim 6: nonionic surfactant is lauroyl polyoxyl-32-glycerides.

This is the most concrete excipient lock. Competitors can avoid literal infringement of claim 6 by selecting a different nonionic surfactant, while still meeting claim 1 unless claim 1 itself narrows to specific surfactants (it does not in the provided text).

Capsule type (claim 7)

• Claim 7: capsule is a gelatin capsule.

This limits literal coverage of claim 7 only. A non-gelatin capsule design might still infringe claim 1 if claim 1 does not require gelatin.

Progesterone release kinetics (claim 8)

• Claim 8: progesterone released more rapidly than progesterone in peanut oil.

This is a functional performance limitation versus a comparator matrix. It is narrower than composition-only elements but can be powerful in enforcement if plaintiffs can demonstrate relative release profiles.

Indication selection and lists (claims 9-12, 14-15, 16)

Claim 9 lists estrogen-deficient states including:

• vasomotor symptom of menopause
• sleep disturbances
• mood changes
• vulvovaginal atrophy
• osteoporosis

Claim 10-12 narrow to vasomotor symptom of menopause and specify:

• hot flashes and night sweats (claim 11)
• post-menopausal woman (claim 12)

Claim 14 narrows to hot flashes/night sweats for claim 13.

Claim 15 specifies mammal as a post-menopausal woman (this overlaps with the typical patient limitation for the method).

What is the practical claim scope for competitors?

Based strictly on the provided claim set, there are three main infringement “attractor fields”:

1. The oil identity and wt% band

   • Oil must be 55 to 75 wt%
   • Predominantly medium chain fatty acid mono- and diglycerides esters of C6 to C12 (and potentially narrower C6-C10, C8-C12, C8-C10 in dependent claims)

2. The progesterone system split

   • 30 to 35 wt% progesterone total
   • contains both:
     • suspended micronized progesterone
     • solubilized progesterone

3. The estradiol solubilization presentation

   • 0.17 to 0.35 wt% estradiol
   • estradiol must be solubilized (and possibly ≥90% in claim 5)

The capsule framing may matter for certain design constraints, but the composition and internal phase requirements are the true lock.

Claim matrix (side-by-side coverage map)

Claim	Treatment target	Estradiol (wt %)	Progesterone (wt %) and form	Oil (wt %) and required identity	Surfactant (wt % / type)	Extra lock
1	Estrogen-deficient state (generic list in claim 9)	0.17-0.35 solubilized	30-35: suspended micronized + solubilized	55-75: predominantly medium chain mono-/diglycerides esters of C6-C12	0.5-10 nonionic	estradiol + both progesterone forms are present in oil
2	As in 1	Same	Same	55-75: predominantly C6-C10	Same	Same	oil range
3	As in 1	Same	Same	55-75: predominantly C8-C12	Same	Same	oil range
4	As in 1	Same	Same	55-75: predominantly C8-C10	Same	Same	oil range
5	As in 1	≥90% solubilized estradiol	Same	Same	Same	Same	solubilization quant
6	As in 1	Same	Same	Same	lauroyl polyoxyl-32-glycerides	Same	surfactant identity
7	As in 1	Same	Same	Same	Same	gelatin capsule	capsule material
8	As in 1	Same	Same	Same	Same	progesterone release faster than peanut oil	functional comparator
9	Selected estrogen-deficient states	Same	Same	Same	Same	enumerated indications	limits indication list
10-12	Vasomotor symptom of menopause	Same	Same	Same	Same	post-menopausal	narrower indication + patient
13	Vasomotor symptom of menopause	Same	Same	Same	Same	all core composition	indication-specific independent
14	Hot flashes/night sweats	Same	Same	Same	Same	as in 13	narrower symptom
15	Post-menopausal woman	Same	Same	Same	Same	as in 13	patient specificity
16	Vulvovaginal atrophy	Same	Same	Same	Same	all core composition	indication-specific independent

How should the “landscape” be read without external bibliographic data?

A complete patent landscape requires bibliographic confirmation (filing dates, assignee, related family members, prosecution history, examiner citations, and forward/backward citations). Those inputs are not present in the prompt. Under strict constraints, the landscape below is limited to a claim-driven competitive inference from the composition and method structure.

What categories of patents are most likely in-scope versus off-target (based on claim structure)?

Even without pulling specific competitor documents, the claim structure implies the following enforcement clusters in the estrogen-progesterone capsule space:

1. Formulation patents for oral estradiol/progesterone delivery systems

   • would compete on excipient matrix identity, solubilization strategy, and release characteristics
   • the medium chain mono-/diglyceride oil system is the distinctive element

2. Particle-engineered progesterone delivery

   • micronized progesterone in a mixed solubilized/suspended arrangement is a differentiator
   • patents focusing only on progesterone form without estradiol solubilization in the same oil may fall outside the core lock

3. Indication method claims for estrogen-deficient states

   • vasomotor symptoms, vulvovaginal atrophy, sleep/mood/osteoporosis categories often have separate method and use claim coverage
   • here, the indication claim set rides on the same formulation requirement

4. Capsule delivery format patents

   • gelatin capsule and other shell formats create narrower dependent-claim space

Where are the strongest “literal” infringement anchors likely to be?

Given the text provided, literal infringement is most likely when a competitor product matches:

• exact wt bands: estradiol 0.17-0.35; progesterone 30-35; oil 55-75; surfactant 0.5-10
• oil identity: medium chain mono-/diglyceride esters C6-C12, predominantly
• internal mixture: solubilized estradiol + suspended micronized progesterone + solubilized progesterone all in that oil
• capsule use: capsule administration

Where are plausible design-arounds suggested by the claim text (claim-by-claim)?

These are claim-text driven and correspond to avoiding at least one required limitation.

• Oil identity: replacing medium chain fatty acid mono-/diglyceride esters with a different lipid class would likely exit claim 1 scope.
• Oil wt%: moving oil outside 55-75 wt% likely avoids claim 1.
• Progesterone split mechanism: if progesterone is not both suspended micronized and solubilized in the oil, claim 1’s “comprising suspended micronized progesterone and solubilized progesterone” may not read on the formulation.
• Surfactant role/type: using a nonionic surfactant outside the claim 6 identity might avoid claim 6 (but not necessarily claim 1, which allows “nonionic surfactant” broadly).
• Estradiol solubilization quant: if estradiol is not at least 90% solubilized, claim 5 is avoided, but claim 1 may still read if estradiol is “solubilized” in general.
• Functional release comparator: changing the delivery so progesterone release is not more rapid than in peanut oil may avoid claim 8, if the court treats claim 8 as requiring that specific comparative outcome.

Key Takeaways

• US 10,675,288 claim scope centers on a capsule formulation with solubilized estradiol (0.17-0.35 wt%) and mixed-form progesterone (30-35 wt%) inside a specific medium-chain mono-/diglyceride ester oil matrix (55-75 wt%, C6-C12 predominantly) with 0.5-10 wt% nonionic surfactant.
• Dependent claims tighten enforceability through oil carbon range selections, ≥90% estradiol solubilization, specific surfactant identity (lauroyl polyoxyl-32-glycerides), gelatin capsule, and a functional release comparison versus peanut oil.
• The independent claim set covers estrogen-deficient states generally and specifically vasomotor symptoms of menopause and vulvovaginal atrophy, but the formulation requirement stays constant across indications.
• Landscape conclusions are constrained by the absence of bibliographic citation data. On claim text alone, the competitive battleground is formulation chemistry: the oil matrix identity and the estradiol/progesterone solubilized-suspended pairing.

FAQs

1. Does US 10,675,288 require both solubilized and suspended progesterone?
   Yes. Claim 1 requires progesterone comprising suspended micronized progesterone and solubilized progesterone.

2. Is gelatin capsule status part of claim 1?
   No. Gelatin capsule appears in dependent claim 7, not in the provided independent claim 1 language.

3. Can a competitor avoid claim 6 by using a different nonionic surfactant?
   Claim 6 is limited to lauroyl polyoxyl-32-glycerides. Using a different nonionic surfactant may avoid literal scope of claim 6, while claim 1 still requires only “nonionic surfactant” within 0.5-10 wt%.

4. What is the key distinguishing feature versus more generic hormone combination patents?
   The distinctive combination of medium chain mono-/diglyceride ester oil (C6-C12) with estradiol solubilized in the oil and a split progesterone system (micronized suspended plus solubilized) in the same oil.

5. Which indications are explicitly claimed in the provided set?
   Vasomotor symptoms of menopause and vulvovaginal atrophy, with broader coverage for additional estrogen-deficient states listed in the provided dependent claim 9 (sleep disturbances, mood changes, osteoporosis).

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References (APA)

No external sources were provided or cited in the prompt, and none can be generated from the claim text alone.

Drugs Protected by US Patent 10,675,288

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						TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS
Mayne Pharma	BIJUVA	estradiol; progesterone	CAPSULE;ORAL	210132-001	Oct 28, 2018		RX	Yes	Yes						TREATMENT OF MENOPAUSE SYMPTOMS, INCLUDING VASOMOTOR SYMPTOMS

International Family Members for US Patent 10,675,288

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
European Patent Office	2782584		301153	Netherlands
European Patent Office	2782584		2021C/558	Belgium
European Patent Office	2782584		122021000080	Germany
European Patent Office	2782584		LUC00245	Luxembourg
European Patent Office	2782584		132021000000197	Italy