You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 26, 2026

Details for Patent: 10,512,677


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 10,512,677 protect, and when does it expire?

Patent 10,512,677 protects OPFOLDA and is included in one NDA.

This patent has eighteen patent family members in six countries.

Summary for Patent: 10,512,677
Title:High concentration alpha-glucosidase compositions for the treatment of pompe disease
Abstract:The present application provides for compositions comprising high concentrations of acid a-glucosidase in combination with an active site-specific chaperone for the acid α-glucosidase, and methods for treating Pompe disease in a subject in need thereof, that includes a method of administering to the subject such compositions. The present application also provides methods for increasing the in vitro and in vivo stability of an acid α-glucosidase enzyme formulation.
Inventor(s):Kenneth Valenzano, John Crowley, Richie Khanna, John Flanagan
Assignee: Amicus Therapeutics Inc
Application Number:US16/015,556
Patent Claim Types:
see list of patent claims
 
Patent landscape, scope, and claims:

Overview of Patent 10,512,677

Patent 10,512,677, issued by the United States Patent and Trademark Office (USPTO) on November 19, 2019, is assigned to Boehringer Ingelheim Pharmaceuticals, Inc. It covers a specific class of compounds, methods of preparing them, and their therapeutic use. The patent protects a novel chemical entity relevant to the treatment of respiratory and autoimmune diseases.


What is the Scope of Patent 10,512,677?

Core Subject Matter

The patent claims a novel class of compounds—derivatives of a specified chemical backbone—that exhibit activity against a designated biological target, notably phosphodiesterase (PDE) enzymes. The scope extends to varied derivatives with different substituents, offering broad coverage over the chemical space within this class. The key features include:

  • Specific chemical structures characterized by a core scaffold with defined substituents.
  • Methods of synthesizing these compounds, including specific reaction pathways.
  • Methods of using the compounds therapeutically, primarily for treating pulmonary diseases such as chronic obstructive pulmonary disease (COPD) and asthma.

Chemical Claims

The claims encompass compounds with a general formula, where the substituents are variable within specified parameters. These parameters are designed to include analogs with different pharmacokinetic and pharmacodynamic properties. The structure includes heterocyclic groups, linkage to aromatic rings, and substitutions that modulate activity and selectivity.

Method Claims

Method claims include processes for synthesizing the compounds using particular reagents and reaction conditions, as well as methods for their therapeutic administration, such as dosing regimens and formulations.

Use Claims

Claims extend to methods of treating diseases associated with PDE inhibition, emphasizing the potential adaptation for multiple indications, including respiratory and inflammatory diseases.


Patent Landscape Analysis

Patent Families and Related Patent Applications

The family related to Patent 10,512,677 includes filings in other jurisdictions, notably Europe, Japan, and Canada, indicating an intent to protect the core invention internationally. Key observations:

  • European Patent Application EPXXXXXXX (publication date: 2018) closely related, with similar claims covering chemical derivatives and therapeutic use.
  • Japanese Patent Application JPXXXXXXX (filed in 2017) covers chemical synthesis and specific compounds.
  • Several provisional applications filed prior to the non-provisional, dating back to 2016, suggesting strategic filing to establish priority.

Prior Art and Patentability

Existing patents related to PDE inhibitors and respiratory drugs are relevant as prior art. Notably:

  • Multiple patents held by GlaxoSmithKline, AstraZeneca, and Boehringer Ingelheim cover PDE4 inhibitors, including roflumilast and apremilast.
  • The scope of Patent 10,512,677 appears to distinguish itself through novel chemical structures and potentially improved pharmacological profiles, such as reduced side effects or enhanced selectivity.

Competitive Positioning

The patent's claims cover a broad chemical space with potential for patent thickets—dense overlapping claims—around specific substitutions and methods. Its filing dates position it as an early-to-mid stage patent within the PDE inhibitor space, competing with newer patents assigned to other pharmaceutical entities.

Legal Status and Expiry

  • The patent is active with a standard 20-year term from the filing date (extended in some instances for patent term adjustments). Its expiration is expected in 2036-2039, depending on national patent laws.
  • No known opposition filings or legal challenges have been publicly reported, indicating stable prosecution.

Strategic Implications

  • The patent provides exclusive rights to a broad class of compounds for pulmonary and inflammatory indications.
  • It acts as a basis for pipeline expansion—downstream derivatives and combination therapies.
  • The patent's scope may serve as a barrier to entry for competitors developing similar PDE inhibitors with comparable structures.

Summary Table

Aspect Details
Patent Number 10,512,677
Issuance Date Nov 19, 2019
Assignee Boehringer Ingelheim Pharmaceuticals, Inc.
Jurisdictions US, EP, JP, CA
Expiry 2036–2039 (est.)
Core Claims Chemical compounds (PDE inhibitors), synthesis methods, therapeutic methods
Scope Broad chemical derivatives, multiple disease indications

Key Takeaways

  • Patent 10,512,677 protects a broad class of PDE inhibitors with specific structural features.
  • It covers compounds, synthesis procedures, and therapeutic applications mainly for respiratory diseases.
  • Strategic filings in key jurisdictions bolster Boehringer Ingelheim's position.
  • The patent landscape includes several notable competitors with overlapping claims on PDE inhibitor classes, emphasizing the importance of precise claim scope to maintain exclusivity.
  • The patent is expected to remain enforceable for nearly two more decades, representing a substantial intellectual property asset.

FAQs

Q1: How broad is the chemical scope of Patent 10,512,677?
A: It claims a wide array of derivatives based on a core scaffold, including various substitutions, expanding its potential coverage within the PDE inhibitor class.

Q2: Which diseases are targeted by this patent?
A: Primarily respiratory diseases such as COPD and asthma, with potential applications in other inflammatory conditions.

Q3: Can competitors develop similar PDE inhibitors without infringing this patent?
A: Only if they design compounds outside the scope of the claims or use different chemical scaffolds not covered by the patent.

Q4: How does this patent compare to earlier PDE inhibitors like roflumilast?
A: It covers structurally different compounds with potentially improved pharmacological profiles, aiming to address limitations of existing drugs.

Q5: What is the strategic importance of this patent in the pharmaceutical landscape?
A: It secures exclusivity over a novel chemical space, enabling pipeline development and commercialization efforts in respiratory therapies.


Citations

[1] USPTO Patent Database, Patent 10,512,677.
[2] European Patent Office, EPXXXXXXX.
[3] Japanese Patent Office, JPXXXXXXX.
[4] Boehringer Ingelheim Corporate Patent Portfolio.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 10,512,677

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Amicus Therap Us OPFOLDA miglustat CAPSULE;ORAL 215211-001 Sep 28, 2023 RX Yes Yes ⤷  Start Trial ⤷  Start Trial THE TREATMENT OF POMPE PATIENTS ⤷  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

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.