US Patent 11,782,041: Scope, claim map, and US patent landscape for abaloparatide β-Asp10 impurity-controlled, pH-stabilized formulations and 80 μg treatment
US Drug Patent 11,782,041 protects a narrow set of abaloparatide drug product formulations defined by (i) concentration 1.8–2.2 mg/mL, (ii) buffer pH 4.5–5.5, and (iii) β-Asp10 level limits (≤3% in independent formulation claim set; broader 0–≤5% in a second independent formulation claim set). It also protects methods of treating a subject using about 80 μg daily abaloparatide, including subcutaneous administration and multi-dose injection pen use over up to 30 days.
What patents protect abaloparatide formulations with pH 4.5–5.5 and controlled β-Asp10 impurity in the US?
Answer (claim scope in US 11,782,041): The independent formulation claims tie protection to a specific impurity profile (β-Asp10 fraction vs total peptide) plus specific physical-chemical targets (pH and concentration). Downstream method claims then add the clinical regimen and delivery device context.
Which claims define the protected formulation “core”?
The patent has two formulation claim families with overlapping structure and different β-Asp10 ranges.
Independent formulation claim (Family A)
- Claim 1: aqueous buffer; abaloparatide 1.8–2.2 mg/mL; pH 4.5–5.5; β-Asp10 ≤3% w/w (based on total peptide content.
- Claim 2 narrows: β-Asp10 ≤1% w/w.
- Claim 3 narrows: β-Asp10 ≤0.5% w/w.
Independent formulation claim (Family B)
- Claim 7: aqueous buffer; abaloparatide 1.8–2.2 mg/mL; pH 4.5–5.5; β-Asp10 between 0% and ≤5% w/w.
- Claim 8: 0.01–≤5%.
- Claim 9: 0.1–≤5%.
Key structural consequence: Family A grants coverage for very low to moderately low β-Asp10 (0 to ≤3%, and narrower to ≤1% and ≤0.5%). Family B covers a wider impurity band (up to ≤5%), but with dependent claims excluding 0% and specifying lower bound ranges.
What does “β-Asp10” range really do to infringement risk?
Because the claims are defined by percentage w/w of β-Asp10 based on total peptide content, infringement in the US turns on measured impurity content under the patent’s claim construction framework. Practically, for a competing formulation, the determinative variable is whether the product’s β-Asp10 falls within the claimed window at release and across shelf life.
What excipients/formulation elements are required?
The claims require an aqueous buffer and specify only:
- drug substance concentration (1.8–2.2 mg/mL),
- buffer pH (4.5–5.5),
- β-Asp10 content limit(s).
No claim language is provided here for specific buffer salts, stabilizers, surfactants, tonicity agents, preservatives, or delivery device coatings. Those elements may be described in the specification, but they are not explicit in the claim text you provided.
When do US patent 11,782,041 claims expire, and how does exclusivity typically play out for abaloparatide products?
Critical timeline mechanics (high level):
- A utility patent’s US term generally runs from the earliest US non-provisional filing date plus 20 years, subject to adjustments (patent term adjustment) and potential terminal disclaimers.
- Abaloparatide’s regulatory exclusivity (5-year NCE/505(b)(2) depending on pathway) and use-label protections (if applicable) can extend beyond the patent landscape, but US 11,782,041 as stated is a formulation and method patent whose practical exclusivity is mostly driven by patent expiration and any regulatory exclusivity overlap.
No filing/priority dates or PTA/TDA facts were provided with US 11,782,041, so a precise “expires on [date]” statement cannot be produced from the provided information alone.
How strong is US 11,782,041 for litigation: what claim breadth and dependency suggests?
Claim breadth profile
- Concentration window is moderate: 1.8–2.2 mg/mL (a 0.4 mg/mL span around a likely ~2.0 mg/mL target).
- pH window is moderate: 4.5–5.5 (covers a full pH unit, but still bounded).
- β-Asp10 defines impurity control with hard cutoffs: ≤3% or ≤1% or ≤0.5%, plus a second family up to ≤5%.
The combination of three quantitative constraints narrows the claim estate relative to a “process-only” or “genus formulation” patent, but it creates a litigation position where the accused product’s analytics are decisive.
Where the claims are weakest (from an infringement perspective)
- A design-around that moves pH outside 4.5–5.5, moves concentration outside 1.8–2.2 mg/mL, or drives β-Asp10 above a claimed ceiling could avoid coverage.
- However, if the alternative formulation is still clinically acceptable and regulators accept it, the design-around is feasible. That feasibility depends on manufacturing constraints and stability behavior.
Where the claims are strongest
- If abaloparatide’s commercial product has been engineered around the same targets, the claims can line up tightly with the commercial formulation and its measured impurity specs.
- Dependent β-Asp10 cutoffs (≤1% and ≤0.5%) give the patentee additional “ladder steps” if the accused product has very low β-Asp10.
What method-of-use and device claims are included in US 11,782,041?
Independent method claims
- Claim 4: administer the formulation of claims 1–3 at about 80 μg daily.
- Claim 10: administer the formulation of claims 7–9 at about 80 μg daily.
Delivery and duration
- Claim 5 / 11: administration is subcutaneous.
- Claim 6 / 12: multi-dose injection pen is used to administer the drug over up to 30 days.
Practical effect: The method claims are not generic “treat osteoporosis” style language (as presented here). They are tightly coupled to:
- the specific formulation constraints,
- the 80 μg daily regimen,
- subcutaneous route,
- a particular pen-based multi-dose administration schedule.
A defendant can potentially avoid method claims by:
- using a different route or dosing schedule, or
- using a different device architecture and administration regimen that does not meet “multi-dose injection pen over up to 30 days” as construed, or
- using a formulation that falls outside claims 1–3 and 7–9.
What generic entry risks exist for abaloparatide products relative to US 11,782,041?
Generic/formulation design-around risks
For a generic or biosimilar-like entrant (abaloparatide is a peptide drug, not a biologic per se in the US regulatory sense), the risk is greatest if the entrant’s product:
- matches the commercial concentration and pH targets, and
- has a β-Asp10 fraction that falls within the claimed windows.
If the entrant’s release specifications for β-Asp10 are within those ranges, the formulation can directly infringe the independent composition claims (1 or 7).
What about method claims?
Even if a generic’s formulation is designed to avoid formulation claim coverage, the method-of-use claims can still be asserted if:
- the ANDA label (or actual use) aligns with 80 μg daily subcutaneous administration,
- and the device and regimen match the pen/multi-dose timeline elements.
Because the method claims incorporate the specific formulation-dependent claims, a clean formulation design-around is usually the first line of defense.
What is the Orange Book status of US 11,782,041, and which ANDA filers face Paragraph IV exposure?
No Orange Book listing data, patent-to-NDA mapping, or Paragraph IV challenge records were provided in the prompt. Without that mapping, the analysis cannot identify:
- which NDA(s) list US 11,782,041,
- whether it is listed for drug substance, drug product, or method-of-use,
- which ANDA applicants filed Paragraph IV notice(s),
- and whether any court actions or settlements occurred.
Given the operating constraints, no partial or speculative Orange Book status can be produced from the claim text alone.
How many patents cover abaloparatide β-Asp10/pH-controlled formulations and 80 μg pen regimens in the US?
No US patent family data beyond US 11,782,041 was provided. The claim set indicates that the patent is likely part of a formulation-optimization and impurity-control strategy, but the number of related US patents cannot be determined without:
- the publication number(s) and family members,
- the specification’s continuation chain,
- and any co-pending or related patents in the same assignee portfolio.
Which companies are likely challenging or defending US 11,782,041?
The prompt provides no assignee, applicant, or litigation parties. Without that, the analysis cannot accurately attribute defense or challenge activity.
What jurisdictions are implicated beyond the US for this formulation concept?
No global filing data (PCT, EP, WO publication, CN) was provided. The claim text alone does not establish where the formulation and impurity concept was pursued internationally.
What patent terms and legal posture matter most for 11,782,041’s commercial impact?
From a legal posture standpoint, the claim structure suggests the central factual issues in US litigation would be:
- Analytical determination of β-Asp10 as a percent w/w of total peptide.
- Verification of formulation concentration (1.8–2.2 mg/mL) at the relevant sampling time (release vs end-of-shelf-life).
- Buffer pH measurement within 4.5–5.5 under the claim’s conditions.
- Use evidence for method claims: dosing at about 80 μg daily, subcutaneous administration, and whether the product is delivered via a multi-dose injection pen and for up to 30 days.
Key Takeaways
- US 11,782,041 is a quantitative formulation patent for abaloparatide drug products: 1.8–2.2 mg/mL, pH 4.5–5.5, and β-Asp10 impurity limits (≤3% / ≤1% / ≤0.5% and a second family up to ≤5%).
- It also covers methods of treating using the protected formulations at about 80 μg daily, including subcutaneous administration and multi-dose injection pen use for up to 30 days.
- Infringement is likely driven by measured analytics (β-Asp10 fraction, pH, concentration) and by how the pen and regimen are used for method claims.
- A design-around path exists in principle via moving outside the claimed numeric windows or changing administration/device regimen, but whether it is feasible depends on manufacturing and regulatory acceptance.
- A complete freedom-to-operate view (Orange Book mapping, Paragraph IV risk, litigation/settlement history, and total patent counts) cannot be generated from the claim text alone.
FAQs
- Does US 11,782,041 require a specific buffer composition, or only pH and aqueous buffer?
- If a product’s β-Asp10 is 2.9% w/w but rises to 3.2% late shelf life, which claim family is implicated?
- How do “about 80 μg” and pen administration over “up to 30 days” affect method claim design-arounds?
- Can a formulation avoid composition claim infringement by adjusting pH but keep concentration and β-Asp10 the same?
- What evidentiary tests typically determine β-Asp10 percentage of total peptide in peptide-drug infringement cases?
References
- Patent claim text provided in the prompt for US Patent 11,782,041.
