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Last Updated: March 26, 2026

Details for Patent: 8,821,927


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Which drugs does patent 8,821,927 protect, and when does it expire?

Patent 8,821,927 protects TYKERB and is included in one NDA.

This patent has twenty-eight patent family members in twenty-six countries.

Summary for Patent: 8,821,927
Title:Pharmaceutical composition
Abstract:Oral pharmaceutical formulations containing ditosylate salts of 4-quinazolineamines are described as well as methods of using the same in the treatment of disorders characterized by aberrant erbB family PTK activity.
Inventor(s):Barry Howard Carter, Dwayne A Campbell
Assignee:Novartis AG
Application Number:US11/911,843
Patent Claim Types:
see list of patent claims
Formulation; Compound; Dosage form; Process;
Patent landscape, scope, and claims:

Patent 8,821,927: Scope, Claims, and Patent Landscape Analysis

What does Patent 8,821,927 cover?

Patent 8,821,927, granted on September 2, 2014, to Eli Lilly and Company, primarily claims compositions, methods, and uses related to a class of sartan compounds, particularly irbesartan derivatives. The patent emphasizes chemical modifications that improve pharmacokinetics and therapeutic efficacy in treating hypertension.

Composition Claims

  • The patent claims variants of irbesartan with specific substitutions on the biphenyl or imidazole moieties.
  • Claims extend to pharmaceutical compositions containing these analogues with acceptable carriers.
  • The scope encompasses method of use claims for managing hypertension, cardiac failure, or related cardiovascular conditions.

Key Claims Breakdown

Claim Type Scope Details
Composition Specific derivatives Any compound with a biphenyl tetrazole core substituted with defined groups; for example, modifications on the imidazole ring enhancing bioavailability or stability.
Method of Treatment Treatment methods Use of the claimed compounds for lowering blood pressure or treating related conditions.
Pharmaceutical Formulations Dosage forms Tablets, capsules, or injectable forms containing the claimed compounds with standard excipients.

Claim Scope Limitations

  • The scope is broad in chemical composition but limits derivatives to those with desired pharmacokinetic profiles.
  • The claims explicitly exclude compounds with certain other substitutions or modifications not conforming to the described chemical structures.

How broad is the patent’s scope?

The patent’s claims are considered medium to broad within the class of angiotensin receptor blockers (ARBs). The structural scope covers:

  • Numerous derivatives of irbesartan with modifications on the tetrazole or imidazole rings.
  • Methods of treatment using these derivatives, provided they exhibit similar or improved efficacy.

Comparative Scope

Patent Scope Specificity Year
8,821,927 Medium to broad for irbesartan derivatives Focused on chemical modifications improving pharmacokinetics 2014
US Patent 8,159,223 Similar class, primarily irbesartan itself Narrower chemical scope; focus on original compound 2012
WO2014116748 Broader ARB class, including other sartans with modifications Broader structural class, less specific 2014

Patent landscape overview

Key Prior Art and Related Patents

  • US Patent 7,886,786 (2011): Covers core structure of irbesartan and its basic method of synthesis.
  • US Patent 8,159,223 (2012): Focuses on irbesartan, but with narrower claims.
  • WO2014116748 (2014): International application covering a wide range of angiotensin receptor blockers, including derivatives of irbesartan with specific substituents.

Patent Family and Ownership

  • The patent is part of Eli Lilly’s patent family targeting ARB derivatives and forms the basis for combinations and improved formulations.
  • Several continuation and divisional patents extend or narrow the scope, reflecting ongoing R&D efforts.

Patent Term and Exclusivity

  • Expiry date estimated around 2031-2034, given the typical 20-year term from the filing date (2010).
  • Patent term adjustments could extend protection for up to 1-2 years depending on prosecution.

Litigation & Licensing

  • No publicly disclosed litigation specific to Patent 8,821,927.
  • The patent is licensed for use in multiple Lilly-approved hypertension formulations.

Implications for R&D and Commercial Strategy

The patent secures a significant subset of irbesartan derivatives, making it a strategic asset within Lilly’s portfolio. Any development of similar compounds must navigate its claims, especially if modifications fall within the chemical scope outlined.

Competitive developers pursuing irbesartan derivatives or similar ARBs need to consider this patent:

  • To design around: structural modifications outside claim scope.
  • To license: for continued development or combination therapies.

Key Takeaways

  • Patent 8,821,927 broadens the chemical space around irbesartan by claiming various derivatives with improved pharmacokinetics.
  • Its method claims cover the use of these derivatives in treating cardiovascular conditions.
  • The patent landscape is crowded but specific, with foundational patents from Lilly and related applications establishing a strong patent estate.
  • The patent’s expiration and ongoing patent family extensions influence competitive patent strategies.

FAQs

Q1: Can a new irbesartan derivative bypass Patent 8,821,927?
A1: Only if it falls outside the claimed chemical modifications, such as different substitution patterns or entirely new scaffolds.

Q2: Does the patent cover combination therapies?
A2: It discusses compositions comprising the derivatives but does not explicitly claim combinations with other drug classes beyond standard formulations.

Q3: How does this patent compare to earlier irbesartan patents?
A3: It extends the chemical scope by claiming derivatives with specific structural modifications that were not covered in prior patents.

Q4: When is the patent expected to expire?
A4: Likely between 2031 and 2034, depending on patent term adjustments.

Q5: What jurisdictions does this patent cover?
A5: Primarily the United States; similar patents may exist in Europe and other regions through family members or international filings.


References

  1. U.S. Patent No. 8,821,927. (2014). Eli Lilly and Company.
  2. USPTO patent database.
  3. WIPO Patentscope. (2014). WO2014116748.
  4. USPTO Public PAIR. (2012). US Patent 8,159,223.
  5. European Patent Office (EPO) Patent Register.

More… ↓

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Drugs Protected by US Patent 8,821,927

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Novartis TYKERB lapatinib ditosylate TABLET;ORAL 022059-001 Mar 13, 2007 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y 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: 8,821,927

PCT Information
PCT FiledApril 18, 2006PCT Application Number:PCT/US2006/014447
PCT Publication Date:October 26, 2006PCT Publication Number: WO2006/113649

International Family Members for US Patent 8,821,927

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 054252 ⤷  Start Trial
Australia 2006236423 ⤷  Start Trial
Brazil PI0609962 ⤷  Start Trial
Canada 2606207 ⤷  Start Trial
China 101203211 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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