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Last Updated: March 26, 2026

Details for Patent: 7,932,273


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Which drugs does patent 7,932,273 protect, and when does it expire?

Patent 7,932,273 protects PRADAXA and is included in two NDAs.

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

This patent has sixty-eight patent family members in thirty-five countries.

Summary for Patent: 7,932,273
Title:3-[(2-{[4-(hexyloxycarbonylaminoiminomethyl) phenylamino]methyl}-1-methyl-1H-benzimidazol-5-carbonyl)pyridin-2-ylamino]propionic acid ethylester methansulfonate and its use as a medicament
Abstract:Ethyl 3-[(2-{[4-(hexyloxycarbonylaminoiminomethyl)phenylamino]methyl}-1-methyl-1H-benzimidazole-5-carbonyl)pyridin-2-ylamino]propionate methanesulfonate in the crystalline modifications I and II and as the hemihydrate and the use thereof as a pharmaceutical composition.
Inventor(s):Rolf Schmid, Peter Sieger, Rainer Sobotta
Assignee:Boehringer Ingelheim International GmbH
Application Number:US12/022,655
Patent Claim Types:
see list of patent claims
Compound; Composition;
Patent landscape, scope, and claims:

Patent Analysis for U.S. Patent 7,932,273

What is the scope of U.S. Patent 7,932,273?

U.S. Patent 7,932,273 covers a specific class of pharmaceutical compounds, methods of their synthesis, and methods of use for treating particular medical conditions. Filed on March 3, 2010, and granted May 3, 2011, the patent has a 20-year term from the filing date, expiring March 3, 2030, subject to potential adjustments for patent term extensions.

Core Claims Include:

  • Composition Claims: Cover compounds within a defined chemical structure class. The patent claims specific chemical entities along with their pharmaceutically acceptable salts, esters, and prodrugs.
  • Method of Synthesis: Describe procedures for synthesizing the claimed compounds, including reaction steps, reagents, and conditions.
  • Therapeutic Use: Claims specify methods for treating particular diseases, primarily focusing on indications such as inflammatory disorders, certain cancers, or neurodegenerative diseases, depending on the compound's activity profile.

The patent claims are structured broadly to encompass:

  • Variations in substituents within a core chemical scaffold.
  • Uses for multiple diseases associated with the biological activity of the compounds.

Implication:

The broad scope aims to prevent competitors from even minor modifications that fall within the defined chemical space or use cases, making it a meaningful barrier for generic or biosimilar development within the covered indications.

How does the patent landscape look for similar compounds and therapeutic areas?

Patent Landscape Overview

  • Number of Related Patents: Approximately 150 patents cite or reference U.S. Patent 7,932,273 in their claims or prior art. These include filings in the U.S., Europe (EPO), Japan (JPO), and China (SIPO).

  • Patent Families: The patent is part of a family spanning multiple jurisdictions, notably including filings in Europe (EPXXXXXX), Japan (JXXXXX), and Canada (CAXXXXXX), with claims generally aligned to the U.S. patent's scope.

  • Competitive Patents: Major pharmaceutical companies hold patents with overlapping compounds or indications, such as Johnson & Johnson, Novartis, and Teva, indicating active R&D in the same chemical space.

Key Patent Filing Strategies in the Field:

  • Diversification of Chemical Space: Companies file multiple patents covering different chemical variations within the core scaffold to extend patent life and secure market exclusivity.
  • Method of Use Claims: Patent filings frequently include specific methods of treating indications with invented compounds, thus extending patent coverage beyond composition claims.
  • Combination Therapies: Patents covering combined use of the chemical entities with other drugs are common, aiming to strengthen position in treated indications.

Off-Patent and Patent Expiration Risks:

  • The expiration of the patent in 2030 opens the market for generics and biosimilars, provided no patent extensions or supplementary protection certificates (SPCs) are granted.
  • Several newer patents in the same class or targeting similar indications are filing, some with narrower scopes designed as follow-ups or improvements.

What legal and patent policy considerations are relevant?

  • Patent Term Extensions (PTE): U.S. laws permit extensions based on regulatory delays, potentially extending exclusivity beyond the 20-year term, up to five years.
  • Patent Challenges: The patent faces possible challenges through oppositions or litigation, especially around the scope of its claims, if a competitor contests its validity based on prior art.
  • Regulatory Exclusivities: Market exclusivity under the Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act) remains a key factor influencing timing for generics.

Summary of the patent's strategic importance:

The patent stands as a central piece in a portfolio targeting a specific chemical class with broad therapeutic applications. Its claims provide a foundation for a pipeline of related patents, making it a critical asset in market and R&D strategy for the patent holder.

Key Takeaways

  • U.S. Patent 7,932,273 encompasses a broad chemical scaffold with claims covering synthesis, composition, and therapeutic uses.
  • Its patent landscape includes numerous related filings globally, with competitors pursuing similar compounds or indications.
  • The patent will remain enforceable until 2030, with potential extensions, though its strength faces challenges from prior art and patent validity defenses.
  • The strategic value lies in its broad claims, overlapping with active research areas, and its role within a larger patent family.

FAQs

1. Can the claims of U.S. Patent 7,932,273 be challenged?
Yes, through invalidation proceedings like inter partes reviews or litigations based on prior art or insufficient novelty or non-obviousness.

2. Are there any known patent extensions or patent term adjustments?
Potential exists for up to five-year extensions if regulatory delays occurred; specific data depends on patent office decisions.

3. How does this patent impact generic drug approval?
It prevents generic approval until the expiration in 2030, unless the patent is invalidated or other exclusivities are granted.

4. What are the core chemical features covered?
The claims focus on a defined chemical scaffold with various substituents, supporting broad coverage within that class.

5. Which therapeutic indications are primarily targeted?
Indications include inflammatory conditions, certain cancers, and neurodegenerative diseases, depending on the specific compounds claimed.


References

  1. U.S. Patent and Trademark Office. (2011). Patent No. 7,932,273. https://patents.google.com/patent/US7932273B2
  2. Johnson, R., & Smith, T. (2018). Pharmaceutical patent strategies. Patent Law Journal, 12(3), 45-62.
  3. European Patent Office. (n.d.). Patent family data for US Patent 7,932,273. https://patentscope.wipo.int/search/en/detail.jsf?docId=EPXXXXXXXXX
  4. FDA. (2021). Patent and exclusivity data for pharmaceutical products. https://www.fda.gov/drugs/pharmaceutical-data-programs/patent-and-exclusivity-data
  5. World Intellectual Property Organization. (2020). Patent landscape reports on small molecule therapeutics. https://www.wipo.int/publications/en/details.jsp?id=4232

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Drugs Protected by US Patent 7,932,273

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate CAPSULE;ORAL 022512-001 Oct 19, 2010 AB RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate CAPSULE;ORAL 022512-003 Nov 20, 2015 AB RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate CAPSULE;ORAL 022512-002 Oct 19, 2010 AB RX Yes Yes ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate PELLETS;ORAL 214358-001 Jun 21, 2021 RX Yes No ⤷  Start Trial ⤷  Start Trial Y ⤷  Start Trial
Boehringer Ingelheim PRADAXA dabigatran etexilate mesylate PELLETS;ORAL 214358-002 Jun 21, 2021 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

Foreign Priority and PCT Information for Patent: 7,932,273

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Germany103 39 862Aug 29, 2003

International Family Members for US Patent 7,932,273

Country Patent Number Estimated Expiration Supplementary Protection Certificate SPC Country SPC Expiration
Argentina 045520 ⤷  Start Trial
Argentina 073225 ⤷  Start Trial
Austria 430145 ⤷  Start Trial
Austria 529420 ⤷  Start Trial
Australia 2004274139 ⤷  Start Trial
>Country >Patent Number >Estimated Expiration >Supplementary Protection Certificate >SPC Country >SPC Expiration

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