Last Updated: August 9, 2026

Patent: 11,491,223


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Summary for Patent: 11,491,223
Title:Pharmaceutical formulations and methods of making the same
Abstract:The invention relates to the formulation of pharmaceutical compositions of etanercept. The invention also relates to methods of removing buffer and of formulating pharmaceutical compositions of etanercept.
Inventor(s):Monica GOSS, Nicole BALL
Assignee: Amgen Inc
Application Number:US16/144,120
Patent Claims:see list of patent claims
Patent landscape, scope, and claims summary:

Patent 11,491,223 Claim Chart and US Patent Landscape Analysis (Exclusivity, Infringement, and Design-Around Risk)

Patent US 11,491,223 is not analyzed below because the claim text was not provided. Without the actual asserted claims (independent and dependent claim language), any “critical analysis of the claims and the patent landscape” would be incomplete and non-actionable for infringement, validity, or design-around decisions.

What claims are in US Patent 11,491,223 and what do they cover?

Answer: Not available.

What the claims say (independent claims)

Not available.

What the claims say (dependent claims)

Not available.

Claim elements that drive infringement vs. non-infringement

Not available.

Likely claim construction pressure points

Not available.

What patents protect the same invention as US 11,491,223?

Answer: Not available.

Direct continuations and related family members

Not available.

US continuations, divisionals, and CIP applications

Not available.

Key overlapping assignees and competitors

Not available.

Prior-art patent families likely cited against 11,491,223

Not available.

When does US 11,491,223 expire, and how do term adjustments or terminal disclaimers change the date?

Answer: Not available.

Statutory expiration timeline

Not available.

Any PTA and PTE impact

Not available.

Terminal disclaimer risk

Not available.

What is the Orange Book status of products covered by US 11,491,223?

Answer: Not available.

Which NDA/ANDA/BLA listings plausibly map to the claimed subject matter

Not available.

Patent listing categories (drug substance, drug product, method of use)

Not available.

How Orange Book listing strength affects Paragraph IV and litigation posture

Not available.

Which companies are challenging coverage similar to US 11,491,223 via Paragraph IV or other routes?

Answer: Not available.

Potential Paragraph IV filers and settlement patterns

Not available.

Court venues and typical time-to-injunction posture

Not available.

If it is a method-of-use scenario, what enforcement route dominates

Not available.

How strong is the patent estate around US 11,491,223 (validity and enforceability)?

Answer: Not available.

Novelty and non-obviousness sensitivity

Not available.

Claim breadth vs. prior art overlap

Not available.

Enablement and written description risk

Not available.

Definiteness risk (means-plus-function, functional language)

Not available.

What formulation, method-of-use, and manufacturing patents compete with US 11,491,223?

Answer: Not available.

Formulation protection

Not available.

Method-of-use protection

Not available.

Device-delivery and process/manufacturing barriers

Not available.

How does US 11,491,223 compare with other patents on the same active ingredient or technology platform?

Answer: Not available.

Side-by-side comparison framework

Not available.

Differentiating claim features

Not available.

Where claim scope likely overlaps competitor filings

Not available.

What patent litigation affects US 11,491,223 (infringement, validity, ITC, or PTAB)?

Answer: Not available.

Related district court cases

Not available.

ITC investigations involving the same asserted subject matter

Not available.

PTAB IPR/PGR activity

Not available.

Final outcomes and what courts held on claim scope

Not available.

What generic entry risks exist for products potentially covered by US 11,491,223?

Answer: Not available.

Likelihood of design-around

Not available.

Potential carve-outs (different salt, different route, different dosing, different device)

Not available.

If the claims track specific process steps, what compliance substitutions exist

Not available.

Key Takeaways

Not available.

FAQs

  1. How do you determine infringement exposure from US method-of-use claim language? Not available.
  2. What timelines govern exclusivity vs. patent expiration for related ANDA challenges? Not available.
  3. Which claim features most often survive obviousness attacks in pharma process patents? Not available.
  4. How do terminal disclaimers change the practical enforceability window? Not available.
  5. What PTAB issues most commonly invalidate narrow pharma claims? Not available.

References

No sources provided for US Patent 11,491,223 claims and landscape in this prompt.

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Details for Patent 11,491,223

Applicant Tradename Biologic Ingredient Dosage Form BLA Approval Date Patent No. Expiredate
Immunex Corporation ENBREL etanercept For Injection 103795 November 02, 1998 ⤷  Start Trial 2038-09-27
Immunex Corporation ENBREL etanercept For Injection 103795 May 27, 1999 ⤷  Start Trial 2038-09-27
Immunex Corporation ENBREL etanercept Injection 103795 September 27, 2004 ⤷  Start Trial 2038-09-27
Immunex Corporation ENBREL etanercept Injection 103795 February 01, 2007 ⤷  Start Trial 2038-09-27
Immunex Corporation ENBREL MINI etanercept Injection 103795 September 14, 2017 ⤷  Start Trial 2038-09-27
Immunex Corporation ENBREL etanercept Injection 103795 ⤷  Start Trial 2038-09-27
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Approval Date >Patent No. >Expiredate

International Patent Family for US Patent 11,491,223

Country Patent Number Estimated Expiration
World Intellectual Property Organization (WIPO) 2018075818 ⤷  Start Trial
United States of America 10307483 ⤷  Start Trial
United States of America 12214013 ⤷  Start Trial
United States of America 2018110856 ⤷  Start Trial
United States of America 2018256718 ⤷  Start Trial
United States of America 2019022217 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration

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