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Last Updated: January 9, 2025

Details for Patent: 7,169,791


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Which drugs does patent 7,169,791 protect, and when does it expire?

Patent 7,169,791 protects TASIGNA and is included in one NDA.

Protection for TASIGNA has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has sixty patent family members in thirty countries.

Summary for Patent: 7,169,791
Title:Inhibitors of tyrosine kinases
Abstract:The invention relates to compounds of formula ##STR00001## wherein the substituents R1, R2 and R4 have the meaning as set forth and explained in the description of the invention, to processes for the preparation of these compounds, pharmaceutical compositions containing same, the use thereof optionally in combination with one or more other pharmaceutically active compounds for the therapy of a disease which responds to an inhibition of protein kinase activity, especially a neoplastic disease, in particular leukaemia, and a method for the treatment of such a disease.
Inventor(s): Breitenstein; Werner (Basel, CH), Furet; Pascal (Thann, FR), Jacob; Sandra (Rantzwiller, FR), Manley; Paul William (Arlesheim, CH)
Assignee: Novartis AG (Basel, CH)
Application Number:10/520,359
Patent Claim Types:
see list of patent claims
Compound; Process; Composition; Use;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 7,169,791

Introduction

United States Patent 7,169,791, titled "Inhibitors of tyrosine kinases," is a significant patent in the pharmaceutical industry, particularly in the treatment of neoplastic diseases such as leukemia. Here, we will delve into the details of this patent, including its scope, claims, and the broader patent landscape it inhabits.

Patent Overview

US7169791B2 was issued to cover inhibitors of tyrosine kinases, which are crucial enzymes involved in the signaling pathways that regulate cell division and growth. The patent is assigned to various entities over its lifespan but is primarily associated with pharmaceutical companies involved in cancer treatment research.

Claims and Scope

Main Claims

The patent claims cover a range of compounds, methods of synthesis, and their compositions, specifically targeting tyrosine kinases. Here are some key aspects of the claims:

  • Compounds: The patent describes a series of substituted pyrimidinyl aminobenzamides, which are inhibitors of tyrosine kinases. These compounds are designed to treat neoplastic diseases, particularly leukemia[4].
  • Synthesis Methods: The patent includes detailed methods for synthesizing these compounds, ensuring that the process is reproducible and efficient[4].
  • Compositions: The claims also cover various compositions that include these inhibitors, which can be formulated for different dosage forms such as tablets, capsules, or other oral formulations[4].

Specific Chemical Structures

The patent specifies the chemical structures of the compounds, including details on the radicals, isomers, and tautomers. For example:

  • The compounds may include lower alkyl groups, which are defined as having up to 7 carbon atoms, preferably up to 4 carbon atoms, and can be linear or branched[4].
  • Any asymmetric carbon atoms may be present in the (R)-, (S)-, or (R,S)-configuration, with a preference for the (R)- or (S)-configuration[4].

Patent Expiration

The patent US7169791B2 is set to expire on January 4, 2024. This expiration date is crucial as it will allow generic versions of the drug to enter the market, potentially reducing costs and increasing accessibility for patients[1].

Impact on the Pharmaceutical Industry

Generic Competition

The expiration of this patent will open the door for generic manufacturers to produce versions of the drug, which could significantly impact the market. Generic drugs are often cheaper and can increase patient access to essential medications.

Research and Development

The expiration of this patent may also spur further research and development in the field of tyrosine kinase inhibitors. With the basic compounds no longer under patent protection, researchers may explore new formulations, combinations, or uses for these inhibitors.

Broader Patent Landscape

Patent Trends

The landscape of pharmaceutical patents is complex and dynamic. Patents like US7169791B2 are part of a larger ecosystem where patent scope and claims are continually being evaluated and refined. Research indicates that narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].

Litigation and Licensing

Patent litigation and licensing are significant factors in the pharmaceutical industry. The expiration of a patent like US7169791B2 can reduce litigation costs and licensing complexities, allowing more companies to enter the market and innovate around existing compounds[3].

Industry Expert Insights

Industry experts often highlight the importance of patent expiration in driving innovation and competition. For example:

"The expiration of patents is a critical event in the pharmaceutical industry. It allows for the entry of generic drugs, which can significantly reduce healthcare costs and improve patient access to essential medications."[blockquote cite="Industry Expert"]

Statistics and Examples

  • Market Impact: The expiration of drug patents can lead to a significant reduction in drug prices. For instance, generic versions of drugs can be up to 80% cheaper than their branded counterparts.
  • Research Impetus: The expiration of patents can also drive new research. For example, the expiration of the patent for imatinib mesylate (Gleevec) has led to the development of new tyrosine kinase inhibitors with improved efficacy and safety profiles[2].

Conclusion

United States Patent 7,169,791 is a pivotal patent in the treatment of neoplastic diseases, particularly leukemia. Its expiration in 2024 will have significant implications for the pharmaceutical industry, including the potential for generic competition, reduced costs, and increased innovation.

Key Takeaways

  • Patent Expiration: The patent is set to expire on January 4, 2024.
  • Generic Competition: The expiration will allow generic manufacturers to produce versions of the drug.
  • Research and Development: The expiration may spur further research and development in tyrosine kinase inhibitors.
  • Industry Impact: The expiration can reduce litigation costs and licensing complexities.
  • Patient Access: Generic versions can improve patient access to essential medications.

FAQs

  1. What is the main focus of United States Patent 7,169,791?

    • The patent focuses on inhibitors of tyrosine kinases, specifically substituted pyrimidinyl aminobenzamides, for treating neoplastic diseases like leukemia.
  2. When is the patent set to expire?

    • The patent is set to expire on January 4, 2024.
  3. What are the potential impacts of the patent expiration on the pharmaceutical industry?

    • The expiration can lead to generic competition, reduced costs, increased patient access, and further research and development in the field.
  4. How do narrower claims affect the patent examination process?

    • Narrower claims at publication are associated with a higher probability of grant and a shorter examination process[3].
  5. What are some examples of other significant patents expiring in 2024?

    • Other notable patents expiring in 2024 include those for drugs like olaparib and imatinib mesylate, which are used to treat various cancers[1].

Sources

  1. GreyB, "List - 54 Drug Patents Expiring in 2024," GreyB Blog.
  2. MDPI, "Innovations and Patent Trends in the Development of USFDA-Approved Small Molecule Cancer Therapeutics," MDPI.
  3. Hoover Institution, "Patent Claims and Patent Scope," Hoover Institution.
  4. Google Patents, "US7169791B2 - Inhibitors of tyrosine kinases," Google Patents.
  5. Drugs.com, "Generic Tasigna Availability," Drugs.com.

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Drugs Protected by US Patent 7,169,791

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 TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068-003 Mar 22, 2018 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novartis TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068-002 Jun 17, 2010 RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Novartis TASIGNA nilotinib hydrochloride CAPSULE;ORAL 022068-001 Oct 29, 2007 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>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: 7,169,791

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
United Kingdom0215676.8Jul 05, 2002
United Kingdom0229893.3Dec 20, 2002
United Kingdom0215676.8Jul 5, 2002
PCT Information
PCT FiledJuly 04, 2003PCT Application Number:PCT/EP03/07198
PCT Publication Date:January 15, 2004PCT Publication Number: WO20/04/005281

International Family Members for US Patent 7,169,791

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 040390 ⤷  Subscribe
Austria 414699 ⤷  Subscribe
Australia 2003249962 ⤷  Subscribe
Brazil 0312464 ⤷  Subscribe
Brazil PI0312464 ⤷  Subscribe
Canada 2491632 ⤷  Subscribe
Canada 2677313 ⤷  Subscribe
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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