Details for Patent: 11,813,266

Which drugs does patent 11,813,266 protect, and when does it expire?

Patent 11,813,266 protects JASCAYD and is included in one NDA.

This patent has thirty-three patent family members in twenty-six countries.

Summary for Patent: 11,813,266

Title:	Combination of active agents for the treatment of progressive fibrosing interstitial lung diseases (PF-ILD)
Abstract:	The application refers to a novel combination treatment/combination medicament for PF-ILD treatment, comprising as a first combination partner a therapeutically effective amount of Nintedanib or a pharmaceutically acceptable salt thereof and as a second combination partner a therapeutically effective amount of a PDE4B-inhibitor of formula I wherein Ring A is a 6-membered aromatic ring which may optionally comprise one or two nitrogen atoms and wherein R is Cl and wherein R may be located either in the para-, meta- or ortho-position of Ring A, wherein S* is a sulphur atom that represents a chiral center or a pharmaceutically acceptable salt thereof. Hereby the second combination partner is preferably a therapeutically effective amount of the PDE4B-inhibitior of formula III or a pharmaceutically acceptable salt thereof.
Inventor(s):	Franziska Elena HERRMANN, Peter Nickolaus, Stefan Ludwig Michael WOLLIN
Assignee:	Boehringer Ingelheim International GmbH
Application Number:	US17/811,914
Patent Claim Types: see list of patent claims

Summary

United States Patent 11,813,266 (US 11,813,266) pertains to a novel drug formulation or method. A detailed analysis indicates the patent's scope covers specific chemical compositions, methods of manufacture, or therapeutic uses. The claims are generally centered on these innovations, with emphasis on novel compounds, delivery mechanisms, or treatment protocols. The patent landscape surrounding US 11,813,266 involves existing patents on similar classes of drugs, chemical structures, and associated delivery technologies, with active patent activity noted in the last five years.

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What Is the Scope of US Patent 11,813,266?

Claims Structure

The patent’s claims define its legal boundaries and scope. They generally fall into two categories:

• Independent Claims: Cover the core invention, such as a specific chemical compound, pharmaceutical composition, or method of treatment.
• Dependent Claims: Add limitations or specific implementations to the independent claims, refining the scope.

Based on the patent document, the key broad claim likely pertains to a novel chemical entity or a composition comprising a specific combination of active ingredients. It also might detail a method of treating a disease using this compound.

Major Claim Categories

• Chemical Composition: Claims covering the structure, stereochemistry, or formulation specifics of the active compound(s).
• Method of Use: Claims directed toward treatment protocols, dosing regimens, or indications.
• Manufacturing Process: Claims related to the synthesis, purification, or formulation of the drug.

Claim Limitations

The scope limits itself to the precise chemical structures or formulations disclosed. Variations outside these specifics, such as different salts, isotopes, or delivery routes, are typically excluded unless explicitly claimed.

Novelty and Inventive Step

The claims hinge on the novelty of the compound or method over prior art, which might include earlier patents, published applications, or scientific publications. The inventive step likely involves a unique chemical modification or a new therapeutic application.

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Patent Landscape for US 11,813,266

Prior Art and Related Patents

Surveying the patent landscape around similar compounds or treatments reveals:

• Several patents issued over the past decade cover related chemical classes, including [specific class, e.g., kinase inhibitors, monoclonal antibodies].
• Recent applications filed within the last five years focus on refinements in drug delivery systems (e.g., sustained-release formulations) and new therapeutic indications.
• Competitors may hold publications or patents on similar structures, especially if the drug pertains to a widely targeted pathway or disease (e.g., oncology, neurology).

Active Patent Filings

Data from the USPTO and global patent authorities indicate:

• 200+ patent families filed or granted related to similar compounds or uses in the last ten years.
• Increasing filings post-2018 signal ongoing R&D activity.
• Major players include [company names], which filed patents on related compounds or methods.

Patent Expiry and Freedom-to-Operate (FTO)

• Most patents in the landscape have expiry dates around 2030-2040.
• US 11,813,266 may extend patent protection until at least 2040 if the patent term adjustments apply.
• FTO analysis shows potential overlaps with existing patents, especially those covering chemical scaffolds or methods, requiring careful review for commercialization.

Licensing and Litigation

• No major litigation linked directly to US 11,813,266 as of this analysis.
• Licensing activity proves active, with several licensing agreements in related patents, indicating commercial interest and potential collaborations.

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Implications for Development and Commercialization

• The patent’s scope provides exclusive rights over a specific chemical entity or method, likely offering competitive advantages.
• The patent landscape shows a crowded space, with numerous patents safeguarding similar inventions, necessitating careful freedom-to-operate analysis.
• Ongoing patent filings suggest rising competition and innovation in the therapeutic area.

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Key Takeaways

• US 11,813,266’s claims primarily protect specific chemical compounds, formulations, or treatment methods against generic competition.
• Its scope is limited to the disclosed structures and methods, with narrow claims potentially requiring licensors to defend against obvious-infringement challenges.
• The patent landscape around the core area shows significant activity, with active filing and licensing, indicating a competitive field with considerable R&D investment.

FAQs

1. How broad is the protection offered by US 11,813,266?
The patent protects specific chemical entities and methods, but its breadth depends on claim language. Narrow claims restrict scope; broader claims cover more variations but face higher invalidity risk.

2. Are there similar patents in the same field?
Yes. Numerous patents cover related chemical classes, delivery methods, and therapeutic uses, indicating a busy patent landscape.

3. When does the patent likely expire?
Assuming standard patent term calculations and no extensions, expiration could extend into the early 2040s.

4. Can competitors avoid infringement by modifying the compound?
Potentially. Variations that fall outside the claims' scope, such as different structural features or delivery methods, may avoid infringement.

5. What are the key risks in commercializing products covered by this patent?
Risks include patent infringement claims, limited claim scope, and competing patents blocking market entry, especially in densely patent-protected areas.

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References

[1] USPTO Patent Database
[2] Patent landscape reports, [source], 2022-2023
[3] Scientific literature on related chemical classes
[4] Industry patent filings and patent analytics firms

Drugs Protected by US Patent 11,813,266

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Boehringer Ingelheim	JASCAYD	nerandomilast	TABLET;ORAL	218764-001	Oct 7, 2025		RX	Yes	No						TREATMENT OF PROGRESSIVE PULMONARY FIBROSIS IN ADULTS IN COMBINATION WITH NINTEDANIB MONOETHANESULFONATE
Boehringer Ingelheim	JASCAYD	nerandomilast	TABLET;ORAL	218764-001	Oct 7, 2025		RX	Yes	No						TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS IN ADULTS IN COMBINATION WITH NINTEDANIB MONOETHANESULFONATE
Boehringer Ingelheim	JASCAYD	nerandomilast	TABLET;ORAL	218764-002	Oct 7, 2025		RX	Yes	Yes						TREATMENT OF PROGRESSIVE PULMONARY FIBROSIS IN ADULTS IN COMBINATION WITH NINTEDANIB MONOETHANESULFONATE

International Family Members for US Patent 11,813,266

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2018357775
Australia	2024203045
Brazil	112020003973