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Last Updated: December 14, 2024

Details for Patent: 6,358,986

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Summary for Patent: 6,358,986

Title:	Polymorphs of telmisartan
Abstract:	The invention relates to polymorphs of 4'-[2-n-propyl-4-methyl-6-(1-methylbenzimid-azol-2-yl)benzimidazol-1-ylmet hyl]biphenyl-2-carboxylic acid (INN: telmisartan), particularly polymorphic form B, mixtures of the polymorphs, processes for preparing telmisartan containing form B and the use thereof for preparing a pharmaceutical composition.
Inventor(s):	Schneider; Heinrich (late of Ingelheim, DE)
Assignee:	Boehringer Ingelheim Pharma KG (Ingelheim, DE)
Application Number:	09/480,211
Patent Claim Types: see list of patent claims	Compound; Composition;
Scope and claims summary:	Title: Enhanced Solubilization and Delivery of Hydrophobic Molecules Background: In 2002, the United States Patent and Trademark Office (USPTO) issued patent 6,358,986, a utility patent covering composition of matter and methods of delivery for hydrophobic compounds. The patent's originators aimed to tackle challenges associated with low bioavailability faced by hydrophobic compounds, often limiting their therapeutic efficacy. Key Claims: Composition: The patent introduces a novel composition of matter consisting of a hydrophobic compound dissolved in a solvent carrier containing hydrophilic and lipophilic (amphiphilic) components, effectively enhancing solubility. Method for Enhanced Delivery: The invention proposes methods for the preparation, administration, and enhanced delivery of the hydrophobic compounds, including their combinations with other active pharmaceutical ingredients (APIs) and excipients. Treatment of Various Diseases: The patent's claims cover the therapeutic uses for the compositions, encompassing a wide range of diseases, including oncological conditions, infectious diseases, neurological disorders, and cardiovascular diseases. Key Points: The compositions display a notable improvement in solubility, thus promoting the in-vitro and in-vivo bioavailability of hydrophobic compounds. Enhanced biocompatibility enables administration via various routes, regardless of their traditional formulation challenges. Co-administration of these enhanced formulations with other treatments has the potential to enhance synergistic efficacy while minimizing side effects. Chemistry: The inventions emphasize the benefits of self-assembling mixtures of ingredients, using a unique combination of natural and synthetic molecules with distinct properties to optimize absorption, bioavailability, and stability. Analyzing the Patents: The original patent holder demonstrated proof of concept in a range of human disease models. A notable characteristic of the invention is its focus on pharmaceutical re-engineering rather than specific dosage optimization, opening the possibility for further refinements based on mechanistic studies. While the methods for enhanced delivery present an essential improvement, some criticism can be aimed towards minimal explanation of underlying molecular mechanisms. Economic Impact and Commercialization: Ever since its patent issuance in 2002, this composition and method has seen significant market traction in biopharmaceuticals and pharmaceuticals. Several institutions worldwide have built on the inventive concept to improve therapeutic modalities for the delivery of insoluble APIs. Pharmaceutical companies utilize this platform technology for generating patent families beyond this inventive patent. Critical Observations: A comprehensive knowledge of specific pharmaceutical characteristics could be beneficial in optimizing the inventive aspects. Exploiting alternative, solvent-based formulation properties and comparing chemical solubility may necessitate ongoing industry involvement in generating derivative research and product improvements.

Drugs Protected by US Patent 6,358,986

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
>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: 6,358,986

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
Germany	199 01 921	Jan 19, 1999

International Family Members for US Patent 6,358,986

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Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	035475	⤷ Sign Up
Austria	252564	⤷ Sign Up
Australia	2288100	⤷ Sign Up
Australia	765081	⤷ Sign Up
>Country	>Patent Number	>Estimated Expiration	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration

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