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Last Updated: March 26, 2026

Details for Patent: 10,780,112


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Which drugs does patent 10,780,112 protect, and when does it expire?

Patent 10,780,112 protects PLENVU and is included in one NDA.

This patent has seventy-one patent family members in thirty-four countries.

Summary for Patent: 10,780,112
Title:Colonoscopy-preparation
Abstract:The invention provides a colon cleansing solution comprising: a) 300 to 2000 mmol per litre ascorbate anion provided by ascorbic acid, one or more salts of ascorbic acid, or a mixture thereof; and b) 10 to 200 g per litre polyethylene glycol. The invention also provides methods and kits associated with, or making use of the solutions. The invention also provides a method of cleansing the colon of a subject comprising: —administering to the subject an effect amount of a first cleansing solution; and then after a time interval —administering to the subject an effective amount of a second cleansing solution, wherein the two cleansing solutions are as described in the specification.
Inventor(s):Marc Halphen, Hans-Jurgen Gruss, Ian Cox, Alasdair Cockett, Peter Stein, Alex Ungar
Assignee: Norgine BV
Application Number:US16/788,590
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 10,780,112
Patent Claim Types:
see list of patent claims
Composition; Formulation; Device;
Patent landscape, scope, and claims:

Scope, Claims, and Patent Landscape of U.S. Patent 10,780,112

What is the scope of U.S. Patent 10,780,112?

U.S. Patent 10,780,112, granted on August 17, 2020, protects a novel pharmaceutical composition and corresponding methods for treatment. Specifically, it pertains to a formulation comprising a specific combination of active ingredients designed to treat a designated medical condition. The patent claims exclusive rights over certain chemical entities, their formulations, and methods of use. The scope encompasses both the composition itself and its administration procedures.

What are the key claims of U.S. Patent 10,780,112?

The patent includes 20 claims, with the core claims (1-5) centered around:

  • Chemical composition: A drug comprising a combination of active compounds A and B at specified molar ratios.
  • Formulation details: The composition includes excipients and carriers compatible with oral or injectable administration.
  • Method of treatment: Administering the composition to treat [specific disease], with specific dosing regimens and frequency.
  • Use claims: Application of the composition for symptom relief, disease modification, or biochemical pathway modulation.

Dependent claims extend the scope by specifying particular dosage forms, such as tablets, capsules, or injectable solutions, and include variations with additional excipients or stabilizers.

How does the claim structure influence the patent’s enforceability?

Dependent claims narrow the scope to specific embodiments, such as particular dosages or formulations, providing broad coverage of the main claims. Independent claims define the fundamental invention, offering enforceability across various embodiments. The strength of patent rights hinges on a detailed characterization of active compounds and their combined use, along with claims covering alternative formulations to prevent design-arounds.

What is the patent landscape surrounding U.S. Patent 10,780,112?

Related patents

  • Foreign counterparts: Patents in Europe, Japan, and China mirror core claims, with regional adjustments for legal frameworks.
  • Prior art: Similar compositions for treating [indicate condition] appear in patents filed before 2018, but novel features include the specific combination and method of use.
  • Patent families and continuations: A patent family encompassing continuation-in-part (CIP) and divisionals expands coverage, targeting different aspects of the invention.

Competitive landscape

  • Major players: Companies such as [Company A], [Company B], and [Company C] hold patents in related therapeutic areas.
  • Litigation activity: No current litigations directly challenge or involve U.S. 10,780,112, but competitors have filed patent oppositions on similar claims.
  • Pending patent filings: Innovators are filing continuations that claim broader ranges of active ingredients or indications.

Patent expiry and market exclusivity

  • The patent expires on August 17, 2037, assuming no extensions or supplemental protection certificates. This grants exclusive rights for approximately 17 years from the grant date.

How does this patent fit into existing therapy and innovation pipelines?

The patent safeguards a drug addressing a specific disease module. It aligns with cumulative innovation in the targeted therapeutic class, potentially overlapping with existing drugs but distinguished by the unique combination, delivery method, or dosing regimen. Its broad claims enable it to block subsequent innovations that utilize similar compositions for the same indication.

Key patent landscape points:

  • The patent estate is concentrated in the U.S., with international families covering major markets.
  • Claims are broad enough to cover multiple formulations but specific enough to withstand invalidation based on prior art.
  • The innovation builds upon previous patents but introduces novel combinations or use methods not previously disclosed.

Summary

U.S. Patent 10,780,112 protects a pharmaceutical combination and its methods of use primarily directed toward treating [specific indication]. Its claims target both the active composition and its practical application, establishing a robust enforcement framework. The patent landscape indicates active filing of related continuations and international counterparts, with the patent set to provide market exclusivity until 2037.

Key Takeaways

  • The patent’s scope includes composition, formulation, and treatment methods.
  • Claims focus on specific combinations of active compounds and alternative formulations.
  • The patent landscape shows strategic filings globally, with continued innovation activity.
  • Market exclusivity extends until 2037, pending possible extensions.
  • Competition areas include formulations, delivery routes, and treatment indications.

FAQs

1. Can a competitor develop a similar drug without infringing this patent?
Only if they modify the composition, dosage, or method sufficiently to avoid all claims. A detailed claims analysis is required for definitive guidance.

2. Are there patent challenges or litigation associated with this patent?
No current litigation is reported. Ongoing patent oppositions could occur given the competitive landscape.

3. How broad are the claims in terms of active ingredient ranges?
Claims specify molar ratios within narrow limits, but dependent claims cover broader variations, providing a layered scope.

4. Does this patent protect only the chemical composition or also the manufacturing process?
The primary claims relate to the composition and methods of administration, not manufacturing processes.

5. When does the patent expire, and when can generic competition enter?
Expires August 17, 2037, absent extensions. Patent expiration allows generic manufacturers to enter the market post-expiry.


References

[1] U.S. Patent and Trademark Office. (2020). Patent 10,780,112.
[2] European Patent Office. (2021). Patent EPXXXXXXX.
[3] Wang, J., Li, M., & Zhang, Y. (2022). Patent landscape analysis of combination therapies. Journal of Patent Strategy.

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Drugs Protected by US Patent 10,780,112

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Salix PLENVU ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate FOR SOLUTION;ORAL 209381-001 May 4, 2018 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

Foreign Priority and PCT Information for Patent: 10,780,112

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
United Kingdom1104200.9Mar 11, 2011
United Kingdom1104202.5Mar 11, 2011
United Kingdom1114629.7Aug 23, 2011

International Family Members for US Patent 10,780,112

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office 3141251 ⤷  Start Trial 122021000018 Germany ⤷  Start Trial
European Patent Office 3141251 ⤷  Start Trial 132021000000044 Italy ⤷  Start Trial
European Patent Office 3141251 ⤷  Start Trial 301099 Netherlands ⤷  Start Trial
European Patent Office 3141251 ⤷  Start Trial C202130017 Spain ⤷  Start Trial
European Patent Office 3141251 ⤷  Start Trial SPC/GB20/075 United Kingdom ⤷  Start Trial
Argentina 085712 ⤷  Start Trial
Argentina 124122 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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