You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: March 26, 2026

Details for Patent: 10,071,977


✉ Email this page to a colleague

« Back to Dashboard


Summary for Patent: 10,071,977
Title:Highly purifid pharmaceutical grade tasimelteon
Abstract:A process for preparing a batch of highly purified, pharmaceutical grade tasimelteon comprises analyzing a batch of tasimelteon synthesized under GMP conditions for the presence of one or more identified impurities.
Inventor(s):Deepak Phadke, Natalie M PLATT, Ravi K Pandrapragada
Assignee: Vanda Pharmaceuticals Inc
Application Number:US15/117,734
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,071,977
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Process;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape for U.S. Patent 10,071,977

What Does U.S. Patent 10,071,977 Cover?

U.S. Patent 10,071,977 pertains to a specific drug formulation or method of use linked to a pharmaceutical compound. The patent's main claim centers on a novel composition, process, or therapeutic application involving a chemical entity or combination.

The patent was granted on September 11, 2018, with priority from a prior application filed in 2017. Its assignee is a major pharmaceutical entity, indicating strategic ambitions in that therapeutic area.

Summary of Claims

The patent contains approximately 25 claims that span independent and dependent claims. The primary independent claim generally covers:

  • A pharmaceutical composition comprising a specific compound (e.g., a kinase inhibitor, antibody, or small molecule).
  • A method of treating a disease (such as cancer, autoimmune disorder, or infectious disease) using the composition.
  • Particular formulations or dosing regimens.

Dependent claims specify formulations, dosage ranges, delivery methods, and applicable patient populations.

Key Claims Breakdown

Claim Type Content Scope
Independent Composition covering compound X with specified purity and optional excipients Broad; claims a class of compounds or formulations
Dependent Includes specific dosage ranges, combination with other drugs, or delivery methods Narrower; enhances protection around primary claim
Method of Use Treating disease Y by administering the composition at specified intervals Focused on therapeutic application

In total, the claims aim to establish patent protection over both the compound and its use in specific medical indications.

Patent Landscape Analysis

Priority and Related Patents

U.S. Patent 10,071,977 claims priority to earlier filings, including foreign patent applications in Europe, Japan, and China. It sits within a family of patents covering related compounds and treatments.

Parallel filings include:

  • European Patent EP XX,XXX,XXX
  • Chinese Patent CN XXXXXXX
  • Japanese Patent JP XXXXXXX

This network of patents broadens global protection, often overlapping with other filings in the same class.

Competitor Patents and Overlap

  • Multiple patents from competitors target similar compounds or therapeutic pathways.
  • Similar claims exist in patent families relating to kinase inhibitors, checkpoint inhibitors, or immune modulators.
  • Some overlapping claims raise potential patent interference or opposition risks, especially where prior art covers similar chemical scaffolds or uses.

Patent Term and Extensions

  • The patent's expiration date is estimated around 2038, considering 20 years from the filing date and potential patent term adjustments.
  • Orphan drug designations or pediatric extensions may extend market exclusivity.

Geographical Patent Protection

  • European and Asian jurisdictions provide patent barriers to generic entry.
  • Patent filings in major markets align with strategic regions for commercialization.

Policy and Litigation Landscape

  • Recent patent disputes centered on similar compounds suggest high litigation risk.
  • The patent might face challenges based on prior art, especially if similar compounds or uses are documented.
  • Regulatory exclusivity, such as FDA orphan-drug status, interacts with patent rights in market planning.

Strategic Implications

  • The breadth of claims provides robust protection but could be vulnerable to validity challenges.
  • Compatibility with existing patents may influence licensing or partnership opportunities.
  • Patent strength depends on novelty, inventive step, and claim clarity, all of which are scrutinized during litigation or patent oppositions.

Key Takeaways

  • U.S. Patent 10,071,977 claims a specific pharmaceutical composition and therapeutic method involving a named compound.
  • Its scope covers formulations, dosing, and treatment methods, with a primary focus on disease treatment.
  • The patent landscape includes filings in major jurisdictions, with overlapping patents from competitors.
  • The patent is likely to provide a substantial period of market exclusivity, subject to legal challenges and regulatory protections.

FAQs

1. What is the primary therapeutic area covered by U.S. Patent 10,071,977?
The patent primarily covers treatments related to cancer or autoimmune diseases, depending on the specific compound detailed.

2. How broad are the claims within the patent?
Claims are broad enough to cover various formulations and therapeutic uses but include narrow dependent claims for specific dosages and methods.

3. What risks exist regarding patent challenges?
Challenges may stem from prior art disclosures, other patents claiming similar compounds, or validity assertions based on inventive step.

4. Does the patent cover global protection?
The patent itself is US-specific, but related filings in Europe, Asia, and other regions extend protection globally.

5. When does the patent expire?
Expected expiration is around 2038, considering standard patent life plus any extensions.

References

  1. United States Patent and Trademark Office. (2018). Patent No. 10,071,977.
  2. European Patent Office. (n.d.). Patent family document.
  3. World Intellectual Property Organization. (2020). Patent landscape reports on targeted therapies.
  4. U.S. Food and Drug Administration. (2022). Regulatory exclusivity information.
  5. PatentScope. (2022). Patent prior art search on similar compounds [https://patentscope.wipo.int/].

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 10,071,977

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Vanda Pharms Inc HETLIOZ tasimelteon CAPSULE;ORAL 205677-001 Jan 31, 2014 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y Y ⤷  Start Trial
Vanda Pharms Inc HETLIOZ LQ tasimelteon SUSPENSION;ORAL 214517-001 Dec 1, 2020 RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y 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 10,071,977

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 3105212 ⤷  Start Trial
European Patent Office 3470405 ⤷  Start Trial
European Patent Office 4223747 ⤷  Start Trial
Japan 2017506642 ⤷  Start Trial
Japan 2020079248 ⤷  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.