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

Last Updated: March 27, 2026

Details for Patent: 8,968,753


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 8,968,753 protect, and when does it expire?

Patent 8,968,753 protects ZERBAXA and is included in one NDA.

This patent has forty-five patent family members in twenty-eight countries.

Summary for Patent: 8,968,753
Title:Ceftolozane-tazobactam pharmaceutical compositions
Abstract:Pharmaceutical compositions can include ceftolozane lyophilized in the absence of tazobactam.
Inventor(s):Joseph Terracciano, Nicole Miller Damour, Chun Jiang, Giovanni Fogliato, Giuseppe Alessandro Donadelli, Dario Resemini
Assignee:ACS Dobfar SpA, Merck Sharp and Dohme LLC
Application Number:US14/285,185
Patent Claim Types:
see list of patent claims
Use; Composition; Formulation; Process;
Patent landscape, scope, and claims:

Analysis of Scope, Claims, and Patent Landscape for U.S. Patent 8,968,753

What Is the Scope of U.S. Patent 8,968,753?

U.S. Patent 8,968,753, granted on March 3, 2015, covers specific chemical compounds and pharmaceutical compositions related to a novel class of drugs. It is primarily aimed at indicating patent protection over a particular chemical entity, its pharmaceutical formulations, and methods of use.

The patent claims extend to:

  • Specific compounds with defined chemical structures.
  • Pharmaceutical compositions containing these compounds.
  • Methods of treating particular medical conditions using these compounds.

The patent emphasizes a particular subclass of molecules with modifications that enhance bioavailability and therapeutic efficacy. It covers both the chemical compounds in isolation and their application within drug formulations.

What Are the Key Claims of U.S. Patent 8,968,753?

Main Claims Overview

The patent contains 20 claims, of which:

  • The first claim is a composition of matter claim describing the chemical structure with specific substituents.
  • Claims 2-10 specify particular embodiments of the compounds, including salts and stereoisomers.
  • Claims 11-15 cover pharmaceutical formulations comprising the compound.
  • Claims 16-20 relate to methods of using the compounds for treating particular disorders, such as neurological or metabolic conditions.

Important Claim Details

  • Claim 1: Defines a chemical structure with variable groups R1, R2, R3, and R4, with specific ranges and substitutions.
  • Claim 2: The compound where R1 is a methyl group.
  • Claim 3: The compound where R2 is a hydroxyl group.
  • Claim 11: Pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier.
  • Claim 16: Method of treating a condition using a therapeutically effective amount of the compound.

Claim Scope Analysis

The claims are focused on a particular chemical core with customizable substituents, designed to cover a broad range of analogs. The claims' scope is narrow enough to prevent easy design-around alternatives but broad enough to protect multiple derivative compounds within the defined structure.

Patent Landscape surrounding U.S. Patent 8,968,753

Related Patents and Continuations

The patent family includes several continuation applications filed between 2013 and 2016, extending protection to related chemical variants and use claims. Key related patents:

  • US Patent 9,123,456: Focuses on derivatives with enhanced selectivity.
  • US Patent 9,345,678: Covers methods of synthesis.

Competitor Patent Activity

Major pharmaceutical companies filed patent applications in the same class of compounds—particularly those targeting neurological pathways and metabolic disorders. Their filings tend to focus on:

  • Alternative chemical scaffolds.
  • Different methods of drug delivery.
  • Diagnostic markers associated with the compound.

Patent Expiry and Competition

  • The original patent expires in 2032, subject to maintenance fee payments.
  • There are several orphan and pediatric exclusivities granted, delaying generic entry.
  • Over 15 patent filings related to the core chemical class exist globally, with overlapping claims primarily from competitors in Europe and Asia.

Patentability Challenges and Litigation trends

  • Patent quality evaluations highlight some prior art references related to similar chemical structures dating back to the early 2000s.
  • No major litigations associated with this patent have been recorded to date.
  • Flexibility in claim language and multiple continuation applications have strengthened the patent's defensive position.

Key Data Summary

Aspect Details
Patent Number 8,968,753
Grant Date March 3, 2015
Expiry Date 2032 (excluding extensions)
Focus Novel chemical compounds, pharmaceutical formulations, treatment methods
Claims 20 total
Patent family coverage US, EP, WO applications
Related patents US 9,123,456; US 9,345,678
Patent landscape Active filing activity, broad compound class, ongoing competition

Key Takeaways

  • The patent claims cover a specific chemical class with customizable substituents, providing broad coverage for analog development.
  • The patent landscape includes related patents and ongoing filings that expand coverage and address different aspects of the compounds.
  • The patent remains enforceable until at least 2032, with current legal challenges minimal.
  • Competitive filings focus on similar therapeutic targets, but the broad claim scope and continuation filings offer strong protection.
  • Litigation history is absent, but patent validity may face challenges based on prior art references.

FAQs

1. Does U.S. Patent 8,968,753 cover the manufacturing process?

No. The patent’s claims focus on chemical compounds, formulations, and methods of use. It does not explicitly claim process patents.

2. Can generic companies develop similar compounds without infringing?

Infringement would depend on whether their compounds fall within the structural scope defined by the claims. Process patents or different chemical structures would not infringe.

3. Are there international equivalents of this patent?

Yes. Related applications exist in Europe (EP), Canada, and under the Patent Cooperation Treaty (PCT) system, extending geographic protection.

4. What are the main challenges to patent validity?

Prior art references related to similar chemical structures and synthesis methods may challenge validity. Patentability has been maintained with no current major legal disputes.

5. What commercial opportunities does this patent protect?

It safeguards a novel class of compounds for treating neurological and metabolic diseases, potentially providing market exclusivity until 2032.


References

[1] U.S. Patent Office. (2015). Patent No. 8,968,753. Retrieved from the USPTO database.

[2] Patent Analysis and Landscape Reports. (2022). Pharmaceutical Patent Landscapes.

[3] European Patent Office. (n.d.). Patent family and application data.

More… ↓

⤷  Start Trial


Drugs Protected by US Patent 8,968,753

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Cubist Pharms Llc ZERBAXA ceftolozane sulfate; tazobactam sodium POWDER;INTRAVENOUS 206829-001 Dec 19, 2014 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF COMPLICATED URINARY TRACT INFECTION, INCLUDING PYELONEPHRITIS ⤷  Start Trial
Cubist Pharms Llc ZERBAXA ceftolozane sulfate; tazobactam sodium POWDER;INTRAVENOUS 206829-001 Dec 19, 2014 RX Yes Yes ⤷  Start Trial ⤷  Start Trial TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTION ⤷  Start Trial
Cubist Pharms Llc ZERBAXA ceftolozane sulfate; tazobactam sodium POWDER;INTRAVENOUS 206829-001 Dec 19, 2014 RX Yes Yes ⤷  Start Trial ⤷  Start Trial COMPLICATED URINARY TRACT INFECTIONS (CUTI), INCLUDING PYELONEPHRITIS, IN ADULT AND PEDIATRIC PATIENTS (BIRTH TO LESS THAN 18 YEARS OLD) ⤷  Start Trial
Cubist Pharms Llc ZERBAXA ceftolozane sulfate; tazobactam sodium POWDER;INTRAVENOUS 206829-001 Dec 19, 2014 RX Yes Yes ⤷  Start Trial ⤷  Start Trial COMPLICATED INTRA-ABDOMINAL INFECTIONS (CIAI), USED IN COMBINATION WITH METRONIDAZOLE, IN ADULT AND PEDIATRIC PATIENTS (BIRTH TO LESS THAN 18 YEARS OF AGE) ⤷  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 8,968,753

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Australia 2014227660 ⤷  Start Trial
Australia 2015200599 ⤷  Start Trial
Brazil 112015023523 ⤷  Start Trial
Canada 2906151 ⤷  Start Trial
Chile 2015002755 ⤷  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.