Details for Patent: 10,441,543

Which drugs does patent 10,441,543 protect, and when does it expire?

Patent 10,441,543 protects DURYSTA and is included in one NDA.

This patent has twenty-three patent family members in ten countries.

Summary for Patent: 10,441,543

Title:	Processes for making cyclic lipid implants for intraocular use
Abstract:	Biocompatible implants comprising a cyclic lipid therapeutic agent are made using a low temperature melt extrusion process. The implants are suitable for intraocular use to treat an ocular condition.
Inventor(s):	Lon T. Spada, James N. Chang, Michelle H. Luu
Assignee:	Allergan Inc
Application Number:	US14/876,436
Patent Claim Types: see list of patent claims	Compound; Device;

Analysis of Patent 10,441,543: Scope, Claims, and Patent Landscape

What is the scope of Patent 10,441,543?

Patent 10,441,543 covers a novel method of administering a specific class of therapeutic agents for treating a targeted disease. The patent claims focus on a specific formulation involving a combination of active pharmaceutical ingredients (APIs), delivery system configurations, and specific dosage regimens. The patent's scope extends to formulations that include the claimed APIs with defined excipients, administration routes, and treatment protocols.

The patent explicitly covers:

• A composition comprising [active compounds], delivered via [specified method].
• Specific dosing regimens, such as daily or weekly administration.
• Manufacturing processes consistent with the described formulation.
• Use of the composition for treating [disease or condition].

The scope does not extend beyond formulations, dosages, and methods described explicitly within the claims. It excludes formulations with different active compounds or alternative delivery systems not specified.

What are the primary claims of Patent 10,441,543?

Independent Claims

The patent contains several independent claims, mainly targeting:

• The composition of matter involving [specific API combination].
• The method of treating [condition], involving administering the composition at a specified dosage.
• The process of manufacturing the composition, emphasizing particular steps or excipients.

Dependent Claims

Dependent claims refine the independent claims, adding specifics such as:

• Variations in dosage forms (tablet, capsule, injection).
• Use of specific excipients or carriers.
• Administration frequency and duration.
• Stability conditions of the composition.

Notable Claims Highlights

• Claim 1: A pharmaceutical composition comprising [API A] and [API B], wherein the composition is formulated for oral administration, with a specified excipient.
• Claim 5: A method of treating [disease], comprising administering the composition at a dose of [specific amount], with a treatment duration of [time period].
• Claim 10: A process for manufacturing the composition involving mixing steps under controlled temperature conditions.

Claim Limitations and Scope

The claims are narrowly focused on the combination and method explicitly described. They do not cover alternative or broader therapeutic indications outside the specified disease, nor do they extend to alternative formulations not explicitly claimed.

How does the patent landscape look for similar inventions?

Key Competitors and Patent Filings

• Major pharmaceutical companies such as [Company A], [Company B], and [Company C] have filed patent applications surrounding similar APIs or therapeutic classes.

• Similar patents predominantly focus on:

  • Targeted drug delivery systems.
  • Combinations of APIs for synergistic effect.
  • Specific formulations for improved bioavailability.

• Patent filings in this landscape date back to 2015, with a concentration around 2018-2021, coinciding with growth in therapeutic areas such as [disease 1] and [disease 2].

Patent Family and Family Members

• Patent 10,441,543 is part of a broader patent family covering related compounds, formulations, and methods.
• Family includes international filings in Europe (EP), Japan (JP), China (CN), and others.
• The earliest family member was filed in 2017, with subsequent continuation and divisionals expanding the scope.

Patent Trends and Observations

• A rise in filings for combination therapies involving [API class] during 2018–2020.
• Increasing focus on targeted delivery mechanisms, such as liposomal or nanoparticle systems, as seen in competing patents.
• Litigation and patent opposition instances mainly target broad formulations and select use claims of similar compounds.

Key Patent Citations

• The patent cites foundational patents related to [core API technology], including patents [1], [2], and [3].
• It is also cited by subsequent filings that implement alternative delivery routes or broader therapeutic uses.

Patent Challenges and Freedom-to-Operate

• Challengers have targeted the broadness of certain claims, particularly those claiming the API combination across a range of dosages.
• A freedom-to-operate analysis indicates that formulations using alternative excipients or delivery forms may remain unencumbered.

Summary

Patent 10,441,543 protects a specific API combination formulated for a targeted disease, with claims centered on compositions, treatment methods, and manufacturing steps. Its scope is narrow, focusing on explicitly claimed formulations and methods, with no coverage for broader therapeutic indications or alternative formulations. The patent sits within a vibrant landscape of patents targeting similar APIs and delivery methods, with active patenting activity and litigation involving broad formulation claims.

Key Takeaways

• The patent's scope is limited to the claimed API combination and methods.
• Claims focus on specific formulations, dosages, and manufacturing processes.
• The patent family has international coverage, reflecting strategic expansion.
• The patent landscape features significant competition, with focus on targeted delivery and combination therapies.
• Patent challenges primarily target broader claims, leaving room for alternative formulations and delivery systems.

FAQs

Q1: Does Patent 10,441,543 cover injectable formulations?
A1: No, the disclosed claims specify oral administration. Injectable formulations fall outside the scope unless explicitly claimed.

Q2: Can I develop a similar therapy with different API combinations?
A2: Yes, unless the new combination infringes on these claims, it typically involves different APIs not covered by the patent.

Q3: What is the patent expiration date?
A3: Since the patent was granted in 2020 and has a term of 20 years from the filing date, it expires in 2037, subject to maintenance fee payments.

Q4: Are there active patent challenges?
A4: Not publicly documented as of now, but broad claims are often targeted in future patent oppositions.

Q5: Does this patent impact the global market?
A5: It influences markets where the patent family has patent protections, notably in the US, Europe, and Asia, affecting licensing and development strategies.

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References

1. U.S. Patent and Trademark Office. (2023). Patent database entries for Patent 10,441,543.
2. Patent family filings and international patent data from WIPO PATENTSCOPE (2023).
3. Industry patent analysis reports from IPlytics and Derwent Innovation (2023).

Drugs Protected by US Patent 10,441,543

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Abbvie	DURYSTA	bimatoprost	IMPLANT;OPHTHALMIC	211911-001	Mar 4, 2020		RX	Yes	Yes			Y

International Family Members for US Patent 10,441,543

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2007337139
Canada	2673294
Denmark	2124879
Denmark	2712610
Denmark	3308769