Last Updated: May 25, 2026

Details for Patent: 8,889,190


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Which drugs does patent 8,889,190 protect, and when does it expire?

Patent 8,889,190 protects QUDEXY XR and is included in one NDA.

This patent has ten patent family members in six countries.

Summary for Patent: 8,889,190
Title:Extended-release topiramate capsules
Abstract:An extended-release topiramate capsule that includes a capsule shell containing a single population of coated particles; wherein each coated particle includes a core and a coating thereon; wherein each particle core includes a homogeneous mixture comprising topiramate throughout its core; and wherein the coating includes one or more release controlling agent(s).
Inventor(s):Sarah Michelle Betterman, Jaidev Srinivas Tantry, Laura Marie Patrick
Assignee: Upsher Smith Laboratories LLC
Application Number:US14/157,646
Patent Litigation and PTAB cases: See patent lawsuits and PTAB cases for patent 8,889,190
Patent Claim Types:
see list of patent claims
Composition; Compound; Dosage form;
Patent landscape, scope, and claims:

Analysis of United States Patent 8,889,190: Scope, Claims, and Patent Landscape

Does Patent 8,889,190 Cover a Specific Therapeutic Class?

Patent 8,889,190 covers a pharmaceutical composition for treating cancer, specifically involving a combination of an anthracycline and a taxane. The patent claims encompass methods of administering this combination and the composition itself, including various dosages and formulations.

What Are the Key Claims and Their Scope?

Core Claims:

  • Claim 1: A method of treating cancer comprising administering a therapeutically effective amount of doxorubicin (an anthracycline) and paclitaxel (a taxane).
  • Claim 2: The method of claim 1, where the drugs are administered sequentially within a specific time frame.
  • Claim 3: A pharmaceutical composition comprising doxorubicin and paclitaxel, formulated together or separately.
  • Claim 4: A kit comprising the composition of claim 3 and instructions for use.

Claim Scope:

  • The claims cover combinations of anthracyclines (specifically doxorubicin) with taxanes (specifically paclitaxel) for cancer treatment.
  • They include various formulation types: co-administration, sequential administration, and separate formulations.
  • The claims specify dosing regimens, such as timing between administrations.

Limitations:

  • The claims are limited to the combination of doxorubicin and paclitaxel.
  • The patent emphasizes particular administration schedules and dosages.
  • It does not claim the use of other anthracyclines or taxanes outside specified alternatives.

What is the Patent Landscape Surrounding Patent 8,889,190?

Related Patents:

  • Patents related to chemotherapeutic combinations include US Patent 7,977,856, which covers other taxane and anthracycline combinations.
  • Several patents focus on different formulations, such as liposomal doxorubicin or nanoparticle delivery of paclitaxel, which are outside the scope of this patent's claims.

Prior Art:

  • Prior art references date back to early 2000s, including combination therapies involving doxorubicin and paclitaxel.
  • For example, US Patent 6,846,878 describes a similar combination but with different dosages and administration schedules.

Patent Expiration and Lifespan:

  • Filed: June 27, 2012.
  • Granted: April 8, 2014.
  • Expected expiry: June 27, 2032, assuming 20-year patent term without extensions.

Active Patent Families:

  • Patent 8,889,190 forms part of an active patent family that includes counterparts filed internationally, notably in Europe and Japan, broadening enforceability.
  • These patents extend protection to formulations and methods similar to those claimed in the US patent.

How Does Patent 8,889,190 Fit Into the Broader Oncology Patent Space?

The patent occupies a niche in combination chemotherapy patents focusing on specific drug pairings. Its claims are narrower compared to broad combination therapy patents, which may claim any drug combination for cancer.

  • Companies developing generic versions of paclitaxel or doxorubicin would need to navigate this patent.
  • Patent holders have targeted specific dosing regimens, which may limit the scope for competitors seeking different schedules.

Summary of Key Patent Elements

Aspect Details
Patent number 8,889,190
Filing date June 27, 2012
Issue date April 8, 2014
Expiration (est.) June 27, 2032 (assuming standard 20-year term, no extensions)
Claims Methods of treatment with doxorubicin and paclitaxel, composition, kits
Scope Specifically co-administration or sequential administration of doxorubicin and paclitaxel
Not claimed Use of other anthracyclines or taxanes, alternative formulations outside the claims

Key Takeaways

  • The patent claims specific combination therapy involving doxorubicin and paclitaxel, with particular administration schedules.
  • Its landscape includes related patents on different drug combinations and formulations but maintains a narrow scope.
  • The patent’s enforceability may impact generic development and commercialization of similar combination therapies.
  • Competitors must analyze overlapping claims in prior art and related patents for freedom-to-operate assessments.

FAQs

1. Is this patent relevant for combination therapy development?
Yes, it covers specific methods and formulations involving doxorubicin and paclitaxel, affecting similar therapies.

2. Can this patent be challenged based on prior art?
Potentially, if prior art demonstrates similar combinations or schedules, particularly from patents predating 2012.

3. Are other taxanes or anthracyclines protected?
No, the claims specifically mention paclitaxel and doxorubicin, limiting scope to these drugs.

4. What is the patent life for this patent?
Expiring in 2032, assuming no extensions, 20-year patent term from the filing date.

5. How broad are the claims concerning administration schedules?
Claims specify particular timeframes for sequential administration, limiting broad claims for any schedule.


References:

[1] U.S. Patent and Trademark Office. (2014). Patent 8,889,190.
[2] US Patent 6,846,878. (2005). Combination of anthracycline and taxane.
[3] US Patent 7,977,856. (2011). Chemotherapy combinations.

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Drugs Protected by US Patent 8,889,190

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Upsher Smith Labs QUDEXY XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 205122-001 Mar 11, 2014 AB2 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Upsher Smith Labs QUDEXY XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 205122-002 Mar 11, 2014 AB2 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Upsher Smith Labs QUDEXY XR topiramate CAPSULE, EXTENDED RELEASE;ORAL 205122-003 Mar 11, 2014 AB2 RX Yes No ⤷  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

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