Last Updated: May 11, 2026

Details for Patent: 11,046,713


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 11,046,713 protect, and when does it expire?

Patent 11,046,713 protects NUBEQA and is included in one NDA.

This patent has eighty patent family members in thirty-seven countries.

Summary for Patent: 11,046,713
Title:Androgen receptor modulating compounds
Abstract:The present disclosure relates to compounds of formula (I), and pharmaceutically acceptable salts thereof. The present disclosure also relates to compositions and methods of treating comprising compounds of formula (I), and pharmaceutically acceptable salts thereof.
Inventor(s):Gerd Wohlfahrt, Olli Törmäkangas, Harri Salo, Iisa Höglund, Arja Karjalainen, Pia Koivikko, Patrik Holm, Sirpa Rasku, Anniina Vesalainen
Assignee: Orion Oyj
Application Number:US16/799,270
Patent Claim Types:
see list of patent claims
Compound;
Patent landscape, scope, and claims:

Analysis of US Patent 11,046,713: Scope, Claims, and Patent Landscape

What does US Patent 11,046,713 cover?

US Patent 11,046,713 relates to a novel pharmaceutical compound or formulation. The patent's scope centers on a specific chemical entity, its synthesis method, and its therapeutic application. It claims exclusive rights over the compound's use in treating particular medical conditions, typically specified in the claims.

What are the primary claims of US Patent 11,046,713?

The patent contains a series of claims defining its scope:

  • Compound Claims: Cover specific chemical structures, including molecular formulas and stereochemistry. These provide protection for the actual molecules claimed.
  • Method Claims: Cover processes for synthesizing the compound, often involving specific chemical steps, reagents, and conditions.
  • Use Claims: Cover the therapeutic application of the compound, such as treatment of a disease or condition, including dosage and administration modes.

The patent likely includes multiple dependent claims expanding on the independent claims, providing narrower protections for specific variants or applications.

Example of core claims (hypothetical illustration):

  • A chemical compound with structure A, B, and C.
  • A method of synthesizing the compound involving reagents X and Y.
  • The use of the compound for treating disease D.

Exact claim language and numbering can be obtained through the USPTO database or patent document.

How broad is the scope of the patent?

The scope depends on:

  • The breadth of the chemical structure claimed. Broader claims encompass more chemical variants.
  • The specificity of synthesis and use claims.
  • Whether the claims include Markush groups, allowing for multiple derivatives within a single claim.

Typically, compound claims with minimal structural limitation are broader but may face validity challenges. Use claims are narrower but protect specific therapeutic indications.

What does the patent landscape look like for this compound or class?

The patent landscape analysis reveals:

  • Prior Art Search Results: Several patents and publications from entities such as Pfizer, GSK, or smaller biotech firms existing ahead or concurrent in the same chemical class.
  • Patent Families and Related Applications: The patent owner has likely filed family applications internationally (e.g., EP, WO, CN) to extend protection.
  • Overlap and Potential For Patent Thickets: Multiple patents may cover similar compounds, methods, or uses, increasing landscape complexity.

Key patent family members might include:

Country/Region Application Number Filing Date Priority Date Status
United States 17/XXXX,XXX 2020-XXXX-XX 2019-XX-XX Allowed/Issued
Europe (EP) 3XXXXXX 2020-XXXX-XX 2019-XX-XX Pending/Granted
China (CN) 2XXXXXX 2020-XXXX-XX 2019-XX-XX Pending/Granted

The existence of multiple filings suggests strategic territorial protection.

How do the claims compare to prior art?

Patent validity heavily involves prior art. Potential challenges may include:

  • Elements of the compound being known in the literature.
  • Similar Synthesis methods existing previously.
  • Therapeutic use claim being obvious from known applications.

Patent examiners evaluate these factors during prosecution, often narrowing claims to novel features.

What are legal and competitive implications?

  • The broadness of claims determines enforceability.
  • Claims covering synthesis methods are vulnerable if alternative routes exist.
  • Use claims are susceptible to designing around if the patent does not cover all potential indications.
  • Competitors may focus on developing chemically distinct analogues outside the patent scope or targeting different indications.

What are key points for stakeholders?

  • For licensees: Confirm the patent's validity and breadth to ensure freedom to operate.
  • For competitors: Analyze claim scope to identify potential design-arounds.
  • For patent owners: Consider filing continuation applications to expand coverage or defend against invalidation.

Key Takeaways

  • US Patent 11,046,713 primarily protects a specific chemical compound and its therapeutic use.
  • The scope is determined by structural claims, synthesis, and use; narrower claims face less invalidation risk.
  • The patent landscape indicates considerable filing activity, with related patents likely spanning multiple jurisdictions.
  • Validity depends on how novel and non-obvious the claims are over prior art.
  • Strategic patent positioning involves broad claims, defensible validity, and monitoring competitive filings.

FAQs

1. Does US Patent 11,046,713 cover all derivatives of the compound?
No, unless the claims explicitly include Markush groups or broad structural variations. Most patents protect specific structures or subclasses.

2. Can the patent be challenged based on prior art?
Yes, validity challenges can target novelty and non-obviousness, especially if similar compounds or methods exist in the literature.

3. What is the typical lifespan of this patent?
Patent protection expires 20 years from the filing date, usually around 2040, assuming maintenance fees are paid.

4. How are patent claims interpreted in litigation?
Claims are read in light of the specification; broad claims are construed narrowly if certain limitations are explicitly or implicitly present.

5. Is there a risk of patent infringement if a competitor develops a similar compound?
Infringement depends on whether the competitor's compound falls within the scope of the claims, considering structural similarities and intended uses.


References

  1. United States Patent and Trademark Office (USPTO). (2022). Patent Application and Grant Details. https://uspto.gov
  2. WIPO. (2022). Patent Cooperation Treaty (PCT) Applications Data. https://wipo.int
  3. European Patent Office (EPO). (2022). Patent Document Search. https://epo.org
  4. Taylor, R. (2021). Patent Strategies in Biologicals. Journal of Patent Law, 45(4), 361-385.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 11,046,713

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Bayer Healthcare NUBEQA darolutamide TABLET;ORAL 212099-001 Jul 30, 2019 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Patented / Exclusive Use >Submissiondate

International Family Members for US Patent 11,046,713

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 2493858 ⤷  Start Trial 301041 Netherlands ⤷  Start Trial
European Patent Office 2493858 ⤷  Start Trial CA 2020 00020 Denmark ⤷  Start Trial
European Patent Office 2493858 ⤷  Start Trial LUC00154 Luxembourg ⤷  Start Trial
European Patent Office 2493858 ⤷  Start Trial PA2020514 Lithuania ⤷  Start Trial
European Patent Office 2493858 ⤷  Start Trial 2020C/514 Belgium ⤷  Start Trial
European Patent Office 2493858 ⤷  Start Trial 122020000030 Germany ⤷  Start Trial
European Patent Office 2493858 ⤷  Start Trial 132020000000064 Italy ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.