US Patent 8,268,806 Landscape: Scope, Claim Breadth, and Competitive Risks for Intravaginal DHEA Precursors and Suppositories
US 8,268,806 covers intravaginal pharmaceutical compositions and vaginal suppositories that use specific sex-steroid precursors at defined low dose levels (up to 13 mg per dosage). Claim coverage centers on (i) the active identity (four enumerated precursors, with DHEA called out separately), (ii) dose thresholds (≤13 mg; dependent ranges and specific amounts such as 6.5 mg and 3.25 mg), and (iii) suppository form plus excipient selection (especially lipophilic glycerides/triglycerides and Witepsol H-15). Practically, the estate is structured to create multiple “entry points” for enforcement: product-by-dose, product-by-excipient, and product-by-specific DHEA + Witepsol H-15 suppository.
What patents protect intravaginal DHEA precursors at ≤13 mg per dosage in US 8,268,806?
Answer (scope in one line): US 8,268,806 protects intravaginal compositions and vaginal suppositories using DHEA and three additional enumerated sex-steroid precursors (DHEA-sulfate, androstenedione, and androstenediol variants) at doses not exceeding 13 mg per dosage, with additional claim coverage for particular excipient classes and the specific base Witepsol H-15.
What is the claimed active ingredient scope?
The independent claim (Claim 1) defines the “sex steroid precursor” group as:
- dehydroepiandrosterone (DHEA)
- dehydroepiandrosterone-sulfate (DHEA-S)
- androst-5-ene-3β,17β-diol
- 4-androstene-3,17-dione (androstenedione)
Claims then create DHEA-specific coverage (Claims 8-12) that is narrower in active identity but broader in enforcement leverage because it ties directly to commercial DHEA vaginal suppository products.
Enforcement consequence: A generic or follow-on developer attempting to avoid infringement by switching away from DHEA into another steroid precursor could still fall within Claim 1 if it selects one of the enumerated precursors and stays within the dose ceiling.
What is the core dose limitation?
Across the claim set, the dosing boundary is the key quantitative limiter:
- Total sex steroid precursor per dosage: ≤13 mg (Claims 1, 3, 8, 17, 20; and dependent claims that specify ranges or exact weights)
Additional dependent claims calibrate dose:
- 3 to 13 mg per dosage (Claim 2; Claim 6; Claim 11; Claim 18)
- exact amounts for suppositories:
- 6.5 mg (Claims 4, 9, 20)
- 3.25 mg (Claims 5, 10, 14, 15)
- and explicit inclusion of 3.25 mg DHEA with Witepsol H-15 (Claims 14-15)
Enforcement consequence: A product at >13 mg per dosage may avoid these claim limits, but only if the formulation still does not satisfy any other independent claim structures in the patent family. Within this US patent’s claim text, dose elevation beyond 13 mg is the clearest path to non-infringement.
What delivery form is covered?
The composition claims target “intravaginal administration,” while the most actionable product claims require vaginal suppositories (Claims 3-23). The strongest commercial attack surface is the suppository format because it narrows design-around options (e.g., switching to gel/cream/tablet).
Key form anchor: “A vaginal suppository comprising…” appears as the central structure in Claims 3-6 and 8-16 and 17-23.
How broad are the excipient claims?
US 8,268,806 uses both:
- open excipient coverage via “pharmaceutically acceptable excipient suitable for vaginal administration” (Claims 3, 17, 21-23), and
- closed lists of specific lipophilic bases (Claims 7, 12, 19), and
- a specific product base: Witepsol H-15 (Claims 13-16, and dependent coverage in 20).
The excipient list (Claims 7, 12, 19) includes lipophilic tri-/di-/monoglycerides of fatty acids, butter, specified oils (palm/palm kernel/cottonseed/coconut and derivatives), hydrogenated fatty alcohols/esters, polyoxyl stearate, rearranged hydrogenated vegetable oils, triglyceride esters, Tween 61, theobroma oil, and combinations.
Claims then also use:
- lipophilic excipient as a dependent limitation (Claims 21-23).
Enforcement consequence: If a competitor uses a lipophilic suppository base that falls within the listed glycerides/oils or uses Witepsol H-15, it moves into the highest-risk zone.
How strong is the patent estate for US 8,268,806 based on claim structure?
Claim strategy: layered breadth
The claim set is designed for both broad and narrow enforcement:
-
Broad identity + quantitative core
Claim 1: intravaginal composition, any of the enumerated precursors, ≤13 mg total precursor per dosage, plus pharmaceutically acceptable excipient.
-
Specific dosage windows
Claim 2 and others carve 3 to 13 mg as a separate infringement “slice,” capturing common low-dose regimens.
-
Form-specific enforcement
Claims 3-6 and 8-11 require “vaginal suppository,” allowing product-by-product enforcement.
-
Dose + exact excipient pairings
Claims 13-16 and 20 explicitly require DHEA + Witepsol H-15, and fix the suppository volume (1.3 mL) plus drug mass (3.25 mg and 6.5 mg).
-
Excipient classification
Claims 7, 12, 19 restrict excipients to a defined set of lipophilic bases, and Claims 21-23 add a “lipophilic excipient” label.
Bottom line: The patent is strong for enforcement against a suppository product that resembles typical DHEA vaginal suppository development: DHEA within a low mg range and a lipophilic fat-like base (Witepsol H-15 or closely related glycerides/triglycerides).
Vulnerabilities implied by the claim text
Within the provided claims, the clearest limitation is the dose cap of ≤13 mg and the product format (suppository) in many key claims. A developer can reduce risk by:
- changing active identity to a non-enumerated steroid precursor,
- changing the dosage per unit to exceed the threshold, or
- changing the dosage form away from “vaginal suppository” (e.g., intravaginal gel/cream, pessary formats that do not satisfy the claim definition, depending on interpretation).
This risk posture is driven by the claims themselves; it is not a commentary on validity.
What formulations are protected by Witepsol H-15 and specific DHEA amounts?
Witepsol H-15 is a high-value dependent claim handle
The patent explicitly claims DHEA suppositories with Witepsol H-15 at defined sizes and drug loads:
| Claim |
Form factor |
Active |
Dose per suppository |
Excipient / base |
| 13 |
1.3 mL vaginal suppository |
DHEA |
6.5 mg |
Witepsol H-15 |
| 14 |
vaginal suppository |
DHEA |
3.25 mg |
Witepsol H-15 |
| 15 |
1.3 mL vaginal suppository |
DHEA |
3.25 mg |
Witepsol H-15 |
| 16 |
vaginal suppository |
DHEA |
3 to 13 mg |
Witepsol H-15 |
| 20 |
vaginal suppository |
DHEA |
6.5 mg |
Witepsol H-15 |
Interpretation for design-around: If a product uses Witepsol H-15 as the suppository base and doses DHEA between 3 and 13 mg, it maps directly into Claim 16 (and into Claims 13, 14/15, and 20 for the exact 6.5 mg and 3.25 mg embodiments).
When does US 8,268,806 lose exclusivity?
Answer: No exclusivity timeline, expiration date, or regulatory exclusivity period can be produced from the claim text alone. The claim excerpt does not include filing date, priority, patent term adjustments, prosecution history, terminal disclaimer, or FDA reference-listed drug/exclusivity linkage.
How many patents cover intravaginal DHEA suppositories in the US?
Answer: Not derivable from the provided information. US 8,268,806 claims alone do not establish whether additional family members exist, whether continuation patents exist, or whether related process/method patents are asserted in the same estate.
What generic entry risks exist for competitors making low-dose intravaginal steroid suppositories?
Risk drivers from the claim boundaries
A competitor faces high infringement risk if its US product satisfies all of:
- Vaginal suppository format (for the suppository claims)
- Active is one of the four enumerated precursors (Claim 1) or DHEA (Claims 8-12 and Witepsol-dependent claims)
- Total precursor per dosage ≤13 mg (core limiter)
- Excipient falls within the listed lipophilic bases or uses Witepsol H-15 (highest-risk dependent claims)
Product design patterns that fall inside the claims
- DHEA suppository at 3.25 mg or 6.5 mg, especially with Witepsol H-15
- DHEA suppository in the 3 to 13 mg window with Witepsol H-15
- If the product uses another enumerated precursor (DHEA-S, androst-5-ene-3β,17β-diol, or 4-androstene-3,17-dione) at ≤13 mg, it still risks falling within Claim 1 and potentially Claim 3 (depending on suppository form and excipient)
Design-around levers grounded in the claim text
- Dose escalation above 13 mg per unit dosage (to step outside the explicit thresholds in Claims 1/2/3/6/8/11/16/17)
- Avoiding the enumerated precursor identities (for Claim 1)
- Avoiding “vaginal suppository” format (for most product claims)
- Changing the base away from Witepsol H-15 and avoiding the specific excipient list (Claims 7/12/19)
What patent litigation affects US 8,268,806?
Answer: No litigation docket dates, venues, asserted claims, or settlement terms can be generated from the provided excerpt. Litigation status requires external case identifiers.
What is the Orange Book status of US 8,268,806?
Answer: Orange Book listings cannot be determined from the claims excerpt. Status requires identification of the FDA NDA/ANDA product mapped to the patent and the specific listed formulation.
How does US 8,268,806 compare with other intravaginal steroid patent estates?
Answer: Comparative landscape analysis requires knowing the patent family set (continuations, divisionals), the asserted claim set in related patents, and the product mapping. The provided excerpt contains only the claim text of one US patent.
Key Takeaways
- US 8,268,806 claim scope is built around intravaginal low-dose steroid precursor therapy with a strict quantitative cap: ≤13 mg per dosage.
- The strongest commercial infringement hook is DHEA vaginal suppositories using Witepsol H-15, including explicit embodiments at 3.25 mg and 6.5 mg and a broader window (3 to 13 mg) with that base.
- Excipient coverage includes lipophilic glyceride/oil classes via a closed list plus broader “pharmaceutically acceptable excipient” language.
- The principal design-around levers reflected in the claim text are dose (>13 mg), active identity (non-enumerated precursor), dosage form (not a vaginal suppository), and excipient/base (not within the specified set and not Witepsol H-15).
FAQs
1) Does US 8,268,806 require 1.3 mL suppositories?
No. The 1.3 mL limitation appears in specific dependent claims (Claims 13 and 15) that cover particular embodiments.
2) If a product uses DHEA at 13 mg per suppository, is it within the claimed range?
Yes, based on the explicit “not exceeding 13 milligrams” language (Claims 1, 3, 8, 17).
3) Are excipient choices limited to the listed oils and triglycerides?
Not in the broad composition claims. The limited excipient list is tied to dependent claims (Claims 7, 12, 19), while other claims allow “pharmaceutically acceptable excipient suitable for vaginal administration.”
4) Can a competitor avoid infringement by using DHEA-sulfate instead of DHEA?
It does not avoid risk for Claim 1 if the active remains within the enumerated precursor group and the dose stays ≤13 mg. Separate DHEA-specific claims (Claims 8-12 and Witepsol-dependent claims) may not apply, but Claim 1 and Claim 3 may.
5) Is this patent limited to suppositories or does it also cover other intravaginal dosage forms?
This excerpt contains both intravaginal “composition” language (Claim 1) and many “vaginal suppository” claims (Claims 3-23). The strongest coverage is for suppositories, but Claim 1 is framed as a composition for intravaginal administration.
References
- United States Patent 8,268,806. (Claims excerpt provided in prompt).
