Details for Patent: 8,580,293

Which drugs does patent 8,580,293 protect, and when does it expire?

Patent 8,580,293 protects MILPROSA and is included in one NDA.

This patent has fifty-four patent family members in twenty-five countries.

Summary for Patent: 8,580,293

Title:	Monolithic intravaginal rings comprising progesterone and methods of making and uses thereof
Abstract:	The present invention relates to monolithic intravaginal rings comprising progesterone, methods of making, and uses thereof. The intravaginal rings comprise progesterone, a polysiloxane elastomer, and a pharmaceutically acceptable hydrocarbon or glycerol esters of a fatty acid.
Inventor(s):	Salah U. Ahmed, Jiaxiang Tsao, Anu Mahashabde, Diane D. Harrison
Assignee:	Ferring BV
Application Number:	US12/364,990
Patent Claim Types: see list of patent claims	Use;

Scope and claims analysis for US Drug Patent 8,580,293 (progesterone monolithic intravaginal ring) with US patent estate, exclusivity, and competitive generic risk

Executive summary. US Patent 8,580,293 is a US method claim family focused on treating luteal phase defects and supporting embryo implantation/early pregnancy using a monolithic intravaginal ring that is defined by: (1) progesterone loading (notably ~15–30% by weight), (2) a polysiloxane elastomer matrix present at ~55–90 wt% (typically dimethylpolysiloxane elastomer optionally with dimethylmethylhydrogen polysiloxane crosslink), and (3) a specific class of lipid/plasticizer excipient present at ~5–10 wt%, either hydrocarbon or glycerol esters of a fatty acid (claims 1–7, 17) or an alternative “oil” embodiment including mineral oil or silicone oil (claims 8–16). The claims are materially constrained by composition ranges, homogeneous dispersion, and release duration (up to ~18 days). The estate strategy indicated by the claim set is to fence out non-identical matrices (other elastomers), non-matching excipient classes, non-homogeneous drug distribution, and different release profiles, while still covering a practical commercial use schedule (ring replacement every ~7 days for ~10 weeks in one embodiment).

---

What is US Patent 8,580,293 claiming for progesterone intravaginal rings (luteal phase defect and embryo implantation)?

Core invention in plain claim terms. The patent claims methods (not apparatus claims) where the method’s step is administering a specific monolithic intravaginal ring containing the defined three-component system. The claims repeatedly use the same structural constraint chain:

1. A monolithic intravaginal ring (single-piece ring; no multi-reservoir architecture stated in the provided claims).
2. Progesterone in a defined concentration range, often 15–30 wt%.
3. A polysiloxane elastomer matrix at 55–90 wt%.
4. A low-percentage excipient at 5–10 wt%, either:
   • Hydrocarbon or glycerol esters of fatty acids (claims 1–7, 17), or
   • Pharmaceutically acceptable oil selected from mineral oil and silicone oil (claims 8–16), with silicone oil combinations allowed.
5. A performance attribute: progesterone is homogeneously dispersed in the elastomer.
6. A pharmacokinetic/process attribute: progesterone is released for up to ~18 days after administration.

How do claims 1–7 differ from claims 8–16 (fatty acid esters vs “oil” subclasses)?

• Claims 1–7: excipient is explicitly hydrocarbon or glycerol esters of a fatty acid at 5–10 wt%.
• Claims 8–16: excipient is a broader pharmaceutically acceptable oil at 5–10 wt%, with explicit examples:
  • Mineral oil
  • Silicone oil
  • combinations.

Practical implication for design-around. A product using fatty acid esters rather than mineral/silicone oil is in the narrower first track; a product using mineral/silicone oil is aimed at the second track. If a generic developer changes the excipient class, they may avoid one track but still risk capture if the excipient falls within the other claim’s language (for instance, if a fatty acid ester is also characterized as a “hydrocarbon or glycerol ester of a fatty acid,” it remains inside claims 1–7 and 17).

---

What are the independent claim anchors and what do they lock down? (Claims 1, 8, and 17)

Claim 1 (fatty acid ester excipient; “up to 18 days” release)

Claim 1 recites a method with a monolithic intravaginal ring comprising:

• progesterone: therapeutically effective amount (with narrower dependent constraints elsewhere),
• polysiloxane elastomer: 55–90 wt%,
• pharmaceutically acceptable hydrocarbon or glycerol ester of a fatty acid: 5–10 wt%,
• polysiloxane concentration and excipient concentration are explicit.

Additional limiting features embedded in dependent claims:

• progesterone loading often limited to 15–30 wt% (claim 5),
• progesterone homogeneously dispersed and release “up to about 18 days” appear as features of claim 6 and claim 7,
• ring composition exemplified (claims 7) with tighter bands:
  • progesterone 15–25 wt%
  • dimethylpolysiloxane elastomer 70–80 wt%
  • fatty acid ester 5–10 wt%
  • release up to ~18 days.

Claim 8 (oil excipient; “up to 18 days” release)

Claim 8 mirrors claim 1 in the core triad, but substitutes excipient class:

• progesterone,
• polysiloxane elastomer: 55–90 wt%,
• pharmaceutically acceptable oil: 5–10 wt%, with dependent claims specifying “oil selected from mineral oil, silicone oil and combinations,” and again adding:
• progesterone loading 15–30 wt% (claim 14),
• ratio and release up to ~18 days in claims 15–16.

Claim 17 (method supporting embryo implantation and early pregnancy)

Claim 17 extends the same ring composition logic to a different indication:

• method supporting embryo implantation and early pregnancy,
• monolithic intravaginal ring with progesterone + polysiloxane elastomer + fatty acid ester class excipient,
• concentration bands match claim 1:
  • polysiloxane elastomer 55–90 wt%
  • hydrocarbon or glycerol ester of fatty acid 5–10 wt%.

Dependent claims 18–21 add:

• patient undergoing assisted reproduction (claim 18) or otherwise infertile (claim 19),
• administering for about 7 days (claim 20),
• replacement schedule: ring replaced about every 7 days for about 10 weeks (claim 21).

Design-around implication. Indication-limited steps can narrow infringement exposure. A competitor using the same ring composition but in a different clinical pathway could reduce method-claim risk, depending on how their clinical use is characterized in the record and what other claims cover.

---

What does “monolithic intravaginal ring” practically mean in the claim scope?

The claims as provided do not explicitly define structural dimensions, porosity, or layered architecture. “Monolithic” is the operative term. Based on claim usage, infringement hinges on whether the ring is a single unified polymeric matrix rather than, for example:

• a multi-layer laminate with distinct diffusion barriers, or
• a reservoir device with discrete drug-core compartments.

Because the provided claim set does not include explicit structural element language (e.g., thickness, seam, layers), most enforceability leverage likely comes from the composition and release limitations (homogeneous dispersion; release up to 18 days) rather than micromechanical architecture.

---

How tightly are composition ranges constrained (wt% bands, ratio, and dispersion)?

Polysiloxane elastomer

Across claims:

• 55–90 wt% (claims 1 and 8 and 17 as ranges).
• Dependent embodiment tightens it to 70–80 wt% in claim 7 and claim 16.

Excipient (two alternative categories)

• Fatty acid ester: 5–10 wt% (claims 1, 7, 17).
• Oil (mineral/silicone): 5–10 wt% (claims 8, 16; with selection limits in 12–13).

Progesterone

• Dependent claim 5 and 14: 15–30 wt%.
• Dependent claim 7 and 16: 15–25 wt%.
• Claim 6 and 15 add ratio framing:
  • claim 6: progesterone-to-elastomer ratio ~1:1 to ~1:10
  • claim 6: progesterone-to-excipient ratio ~1:0.1 to ~1:100
  • claim 15: ring ratio about 4:15:1 (progesterone : dimethylpolysiloxane elastomer : oil, respectively).

Homogeneous dispersion requirement

Claims 6 and 7 (fatty acid ester track) and claims 15 and 16 (oil track) specify:

• progesterone is homogeneously dispersed in the elastomer.

This clause can matter if a competitor uses:

• particulate suspension,
• crystalline dispersion zones,
• core-shell drug segregation,
• phase-separated drug distribution.

Release duration requirement

Claim 6 and 7 and claim 15 and 16 specify progesterone is released:

• “for up to about 18 days after administration.”

Competitors with faster release (e.g., designed for 7–14 day exposure) may avoid. Competitors with slower release (beyond 18 days) could still arguably fall within “up to” depending on claim construction; the phrase is ambiguous in isolation but is intended to cover a release ceiling.

---

Which polysiloxane elastomers are singled out (dimethylpolysiloxane and crosslinking)?

Dependent claims narrow the elastomer identity and, for at least one embodiment, specify crosslink chemistry.

Claims 2–4 (fatty acid ester track)

• claim 2: diorganopolysiloxane elastomer.
• claim 3: dimethylpolysiloxane elastomer.
• claim 4: dimethylpolysiloxane further comprises dimethylmethylhydrogen polysiloxane crosslink.

Oil track (claims 9–11)

• claim 9: diorganopolysiloxane elastomer.
• claim 10: dimethylpolysiloxane elastomer.
• claim 11: crosslink includes dimethylmethylhydrogen polysiloxane.

Scope effect. The independent claims are not limited to dimethylpolysiloxane; they require “polysiloxane elastomer” broadly within the wt% band. If a competitor uses a different polysiloxane class (still polysiloxane), it could still fall under the independent claims. If they use a non-polysiloxane elastomer system (e.g., polyurethane, EVA), they likely avoid the independent claim’s elastomer requirement.

---

How do the indication and administration claims expand the clinical use footprint (claims 17–21)?

Embryo implantation and early pregnancy method

Claim 17 defines the method:

• supporting embryo implantation and early pregnancy
• via administration of the defined ring.

Patient population qualifiers

• claim 18: assisted reproductive treatment program.
• claim 19: “otherwise infertile.”

Timing and schedule constraints

• claim 20: administering for about 7 days.
• claim 21: ring replaced about every 7 days for about 10 weeks with a new ring.

Risk mapping.

• If a competitor markets an intravaginal progesterone ring for luteal support but not embryo implantation/early pregnancy, the claim 17 track may not be implicated.
• If a competitor uses the ring off-label (in a way that matches these method steps), method-claim exposure depends on evidence of use.

---

What is the patent estate scope around US 8,580,293 (continuations, claim sets, and likely enforcement boundaries)?

No additional bibliographic data, citation graph, or family member listing is included in the prompt. Without the patent’s patent number bibliographic record (application number, earliest priority, inventors/assignees, related US publications, and legal status), it is not possible to produce a complete, accurate landscape of:

• continuation/divisional descendants,
• related kit/device method claims,
• terminal disclaimers,
• assignment chain and current owner,
• overlap with other progesterone vaginal ring or luteal defect patents,
• litigation history tied to this specific case.

Per the task constraint, only the scope that can be derived from the provided claim text is analyzed here.

---

What claims are most likely to be asserted in practice (high-probability infringement elements)?

Based on the provided claim set, enforcement most commonly targets:

1. Composition-matching elements: progesterone wt% plus elastomer wt% plus excipient wt% and class.
2. Matrix constraints: “homogeneously dispersed” and elastomer identity (if dependent claims are asserted).
3. Performance constraint: “released for up to about 18 days.”
4. Indication method steps: luteal phase defect and embryo implantation/early pregnancy.

The strongest “lock” for a design-around is typically the combination of:

• polysiloxane elastomer at 55–90 wt%,
• excipient at 5–10 wt% in the specific category (fatty acid esters or oil),
• progesterone homogeneously dispersed,
• release for up to ~18 days.

A generic or authorized copy that changes one major dimension (elastomer type, excipient class, dispersion method, or release profile) can reduce claim match probability, even if other features align.

---

Generic and biosimilar risk: what would likely matter for market entry?

No FDA reference product, Orange Book listing, or application pathway data is included in the prompt. Without that, a complete paragraph IV/biosimilar risk analysis cannot be produced accurately.

From a purely patent-claim standpoint, the most relevant entry risk drivers for a progesterone intravaginal ring product are:

• whether the ring is “monolithic,”
• whether the polymer matrix is within the polysiloxane elastomer category and wt% window,
• whether the excipient matches fatty acid ester class (or mineral/silicone oil class),
• whether progesterone loading is within 15–30 wt% (or tighter 15–25 wt%),
• whether progesterone is homogeneously dispersed,
• whether release duration falls within “up to about 18 days.”

---

Key Takeaways

• US 8,580,293 is a method patent whose infringement hinges on administering a specific monolithic progesterone intravaginal ring composition and performance profile.
• The ring is defined by: progesterone (often 15–30 wt%) + polysiloxane elastomer (55–90 wt%) + excipient (5–10 wt%) with two excipient tracks: fatty acid esters or mineral/silicone oils.
• Dependent claim sets lock down elastomer identity (dimethylpolysiloxane, optionally with dimethylmethylhydrogen crosslink) and manufacturing/distribution behavior (homogeneous dispersion).
• Multiple claims require progesterone release for up to ~18 days, which is the most direct pharmaceutical performance constraint for design-around.
• The clinical-use scope includes luteal phase defect treatment and embryo implantation/early pregnancy support, with additional patient/program and schedule features (7-day administration; replacement every 7 days for ~10 weeks).

---

FAQs

1. What is the main compositional boundary that differentiates claim 1 from claim 8?
Claim 1 requires a hydrocarbon or glycerol ester of a fatty acid at 5–10 wt%. Claim 8 requires a pharmaceutically acceptable oil at 5–10 wt%, selected from mineral oil and silicone oil (and combinations).

2. Which dependent claims impose the “up to about 18 days” release constraint?
The “up to about 18 days” language appears in the dependent claim cluster: claim 6 and claim 7 (fatty acid ester track) and claim 15 and claim 16 (oil track).

3. Do the independent claims require dimethylpolysiloxane elastomer specifically?
No. Independent claims require a polysiloxane elastomer in the specified wt% range. Dependent claims narrow to diorganopolysiloxane and then dimethylpolysiloxane, with optional crosslink specification.

4. How do the claims treat progesterone distribution in the ring?
They require that progesterone is homogeneously dispersed in the elastomer in the dependent claims that include the ratio and release features (notably claims 6–7 and 15–16).

5. Does the patent cover both luteal phase defects and early pregnancy support?
Yes. Claim 1 and 8 cover treating a luteal phase defect, and claim 17 covers supporting embryo implantation and early pregnancy, with schedule and patient-program dependent claims.

---

References

No external sources were cited because US 8,580,293 bibliographic details, legal status, and FDA/Orange Book context were not provided in the prompt.

Drugs Protected by US Patent 8,580,293

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Ferring Pharms Inc	MILPROSA	progesterone	SYSTEM;VAGINAL	201110-001	Apr 29, 2020		DISCN	Yes	No						METHOD OF SUPPORTING EMBRYO IMPLANTATION AND EARLY PREGNANCY BY SUPPLEMENTATION OF CORPUS LUTEAL FUNCTION AS PART OF AN ASSISTED REPRODUCTIVE TECHNOLOGY (ART) TREATMENT PROGRAM FOR INFERTILE WOMEN

International Family Members for US Patent 8,580,293

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	070561
Australia	2009210779
Brazil	PI0905946
Canada	2713943