You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 16, 2025

Details for Patent: 7,838,027


✉ Email this page to a colleague

« Back to Dashboard


Which drugs does patent 7,838,027 protect, and when does it expire?

Patent 7,838,027 protects PROTONIX and is included in one NDA.

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

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

Summary for Patent: 7,838,027
Title:Pantoprazole multiparticulate formulations
Abstract:Pantoprazole sodium multiparticulates are described which avoid sticking to nasogastric and gastronomy tubes. The pantoprazole multiparticulates have a spheroid core of pantoprazole or an enantiomer thereof, or a salt thereof, a surfactant, and a disintegrant; a sub coat which is comprised of hydroxypropyl methylcellulose (hypromellose) and water, an enteric coat on the sub-coat, and a final seal coat over the enteric coat, which is composed of hydroxypropyl methylcellulose (hypromellose) and water.
Inventor(s): Venkata Ramana Rao; Sripriya (Iselin, NJ), Shah; Syed M. (East Hanover, NJ), Tatapudy; Hanumantharao (Suffern, NY), Saunders; Richard William (Palisades, NY), Fawzi; Mahdi (Morristown, NJ), Nagi; Arwinder (Thiells, NY), Singh; Shailesh (Bardonia, NY), Hasan; Sumon A. (Monroe, NY)
Assignee: Wyeth LLC (Madison, NJ)
Application Number:10/574,210
Patent Claim Types:
see list of patent claims
Compound; Dosage form; Use; Formulation;
Patent landscape, scope, and claims:

Understanding the Scope and Claims of United States Patent 7,838,027

Introduction

United States Patent 7,838,027, titled "Pantoprazole multiparticulate formulations," is a significant patent in the pharmaceutical industry, particularly for the drug Protonix, which is used to treat gastroesophageal reflux disease (GERD) and other conditions. This patent, held by Wyeth Pharmaceuticals (now part of Pfizer), covers specific formulations of pantoprazole sodium.

Patent Overview

Patent Number and Title

  • Patent Number: US7838027B2
  • Title: Pantoprazole multiparticulate formulations[4].

Publication and Priority Dates

  • Publication Date: The patent was published on September 28, 2010.
  • Priority Date: The application was filed on December 19, 2004[4].

Scope of the Patent

Invention Description

The patent describes pantoprazole sodium multiparticulates designed to avoid sticking to nasogastric and gastrostomy tubes. This is a critical innovation because it enhances the ease of administration and reduces the risk of clogging these tubes, which is a common issue with traditional formulations[4].

Claims

The patent includes multiple claims that define the scope of the invention. Here are some key aspects:

  • Claim 1: This claim describes the multiparticulate formulation of pantoprazole sodium, including the composition and the method of preparation.
  • Subsequent Claims: These claims detail various aspects of the formulation, such as the use of specific excipients, the particle size distribution, and the method of coating the multiparticulates to prevent sticking[4].

Patent Claims Analysis

Independent Claim Length and Count

Research on patent scope suggests that the length and count of independent claims can be indicative of the patent's breadth and quality. For US7838027B2, the independent claims are detailed but not overly broad, suggesting a well-defined scope that is less likely to be challenged for being too vague or overly broad[3].

Claim Language

The claim language is specific and technical, ensuring that the patent covers the exact formulation and method of preparation without leaving room for ambiguity. This specificity is crucial for maintaining the patent's validity and preventing generic entry based on minor variations[3].

Patent Landscape

Related Patents

The patent landscape for pantoprazole sodium includes several related patents, each covering different aspects of the drug's formulation and use. For example:

  • US7544370: Covers pantoprazole multiparticulate formulations with a focus on pediatric use.
  • US7550153 and US7553498: Also cover multiparticulate formulations with specific expiration dates[5].

Patent Expiration Dates

  • US7838027B2: The patent is set to expire on September 30, 2024, although there are pediatric extensions that could extend the exclusivity period until March 30, 2025[2][5].

Patent Term Extension (PTE)

Regulatory Review and Clinical Trials

The patent term extension (PTE) is a critical aspect of pharmaceutical patents, allowing firms to restore up to five years of patent protection for time spent in clinical trials and regulatory review. For US7838027B2, any PTE would have been calculated based on the time spent in these phases, up to a maximum of five years[1].

PTE Eligibility

To be eligible for PTE, the patent must be in force when the drug is approved by the FDA and must cover the product or substance, a method of using the product, or a method of manufacturing the product. In this case, the patent covers the specific formulation and manufacturing process of pantoprazole sodium multiparticulates[1].

Impact on Generic Entry

Exclusivity Periods

The expiration of the patent and any associated exclusivity periods are crucial for generic manufacturers. Once the patent expires, generic versions of the drug can enter the market, provided they do not infringe on any remaining patents or exclusivity rights. For pantoprazole sodium, several generic applications have been filed, with the first generic version approved by the FDA[2][5].

Competitive Landscape

The approval of generic versions will significantly impact the competitive landscape for Protonix. Generic entry typically leads to a reduction in prices and increased competition, which can erode the market share of the brand-name drug. However, the specific formulation and manufacturing process covered by US7838027B2 may still offer some competitive advantages until all related patents expire[2].

Conclusion

United States Patent 7,838,027 is a key patent in the pharmaceutical industry, particularly for the treatment of GERD and related conditions. The patent's scope and claims are well-defined, covering a specific formulation of pantoprazole sodium that enhances its administration. Understanding the patent landscape, including related patents and expiration dates, is crucial for both the patent holder and potential generic manufacturers.

Key Takeaways

  • Patent Scope: The patent covers pantoprazole sodium multiparticulate formulations designed to avoid sticking to nasogastric and gastrostomy tubes.
  • Claims Analysis: The claims are specific and technical, ensuring a well-defined scope.
  • Patent Landscape: Several related patents cover different aspects of pantoprazole sodium formulations.
  • Patent Expiration: The patent is set to expire on September 30, 2024, with potential pediatric extensions.
  • Generic Entry: Generic versions can enter the market after patent expiration, significantly impacting the competitive landscape.

FAQs

  1. What is the main innovation covered by US7838027B2?

    • The main innovation is the development of pantoprazole sodium multiparticulates that avoid sticking to nasogastric and gastrostomy tubes.
  2. When is the patent set to expire?

    • The patent is set to expire on September 30, 2024, with potential pediatric extensions until March 30, 2025.
  3. What is the impact of patent term extension (PTE) on pharmaceutical patents?

    • PTE allows firms to restore up to five years of patent protection for time spent in clinical trials and regulatory review.
  4. How does the expiration of US7838027B2 affect generic entry?

    • Once the patent expires, generic versions of the drug can enter the market, provided they do not infringe on any remaining patents or exclusivity rights.
  5. What are the competitive implications of generic entry for Protonix?

    • Generic entry typically leads to a reduction in prices and increased competition, which can erode the market share of the brand-name drug.

Sources

  1. NBER Working Papers Series: THE NBER ORANGE BOOK DATASET
  2. Drugs.com: Generic Protonix Availability
  3. SSRN: Patent Claims and Patent Scope
  4. Google Patents: US7838027B2 - Pantoprazole multiparticulate formulations
  5. Pharsight: Drug Patents containing Pantoprazole Sodium

More… ↓

⤷  Try for Free


Drugs Protected by US Patent 7,838,027

Showing 1 to 1 of 1 entries

Foreign Priority and PCT Information for Patent: 7,838,027

PCT Information
PCT FiledSeptember 30, 2004PCT Application Number:PCT/US2004/033058
PCT Publication Date:April 14, 2005PCT Publication Number: WO2005/032513

International Family Members for US Patent 7,838,027

CountryPatent NumberEstimated ExpirationSupplementary Protection CertificateSPC CountrySPC Expiration
Argentina 045956 ⤷  Try for Free
Australia 2004278037 ⤷  Try for Free
Brazil PI0415014 ⤷  Try for Free
Canada 2539982 ⤷  Try for Free
China 1886119 ⤷  Try for Free
Colombia 5690538 ⤷  Try for Free
Costa Rica 8318 ⤷  Try for Free
>Country>Patent Number>Estimated Expiration>Supplementary Protection Certificate>SPC Country>SPC Expiration
Showing 1 to 7 of 7 entries

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.