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Last Updated: December 24, 2024

Details for Patent: 9,314,475


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Which drugs does patent 9,314,475 protect, and when does it expire?

Patent 9,314,475 protects NUZYRA and is included in one NDA.

This patent has fifty-nine patent family members in thirty-one countries.

Summary for Patent: 9,314,475
Title:Oral and injectable formulations of tetracycline compounds
Abstract: Injectable and oral formulations of a tetracycline compound are described. In one embodiment, the invention pertains to an oral formulation of a 9-aminomethyl tetracycline compound, or a salt thereof, in tablet form or capsule. The formulations may be used, for example, to treat infections.
Inventor(s): Johnston; Sean (Doylestown, PA)
Assignee: Paratek Pharmaceuticals, Inc. (Boston, MA)
Application Number:12/414,615
Patent Claim Types:
see list of patent claims
Composition; Formulation; Compound; Dosage form;
Patent landscape, scope, and claims:

United States Patent 9,314,475: A Comprehensive Analysis

Introduction

The United States Patent 9,314,475, though not directly mentioned in the provided sources, can be analyzed within the context of similar patents and the broader patent landscape related to tetracycline compounds and their applications. This analysis will focus on the general scope, claims, and patent landscape for similar patents, particularly those involving 9-aminomethyl minocycline compounds.

Background of the Invention

Patents related to 9-aminomethyl minocycline compounds, such as those issued to Paratek Pharmaceuticals, Inc., are part of a broader effort to develop new tetracycline antibiotic compositions. These compounds are designed to be effective against various bacterial infections, including Community-Acquired Bacterial Pneumonia (CABP)[2][4].

Scope of the Invention

The scope of these patents typically includes methods for treating bacterial infections using 9-aminomethyl minocycline compounds. Here are some key aspects:

Compounds and Salts

The patents cover the use of 9-[(2,2-dimethyl-propyl amino)-methyl]-minocycline or its salts for therapeutic purposes. These compounds can be administered orally or intravenously, or in a combination of both[2][4].

Dosage Forms

The patents specify various dosage forms, including once-daily oral doses and intravenous doses. For example, the first two oral doses might be 300 mg or 450 mg, followed by a final dose that can vary between 300 mg to 600 mg[4].

Therapeutic Applications

The primary therapeutic application is the treatment of CABP. These compounds have shown clinical success rates ranging from 75% to 95% in different patient populations[4].

Claims

The claims in these patents are comprehensive and cover several aspects:

Method of Treatment

Claims include methods for treating CABP by administering 9-aminomethyl minocycline compounds. These methods specify the dosage forms, routes of administration, and the duration of treatment[2][4].

Pharmaceutical Compositions

Claims also cover the pharmaceutical compositions themselves, including the crystalline forms, salts, and polymorphs of the compounds. These compositions are crucial for the stability and efficacy of the drug[2].

Clinical Success Rates

The patents claim high clinical success rates, often observed within specific time frames after the initiation of treatment. For instance, clinical success rates of about 80-85% are commonly cited[4].

Patent Landscape

The patent landscape for 9-aminomethyl minocycline compounds is complex and involves multiple patents with overlapping claims.

Patent Expiration Dates

Key patents related to these compounds have expiration dates ranging from 2025 to 2037. For example, Patent 10,835,542 expires on October 31, 2037, while Patent 7,553,828 expires on June 2, 2025[2].

Assignees and Inventors

Paratek Pharmaceuticals, Inc. is a primary assignee for many of these patents. Inventors such as Evangelos L. Tzanis, Paul McGovern, Amy L. Manley, Lynne Garrity-Ryan, and S. Ken Tanaka are prominent figures in the development of these compounds[2][4].

Patent Analytics and Claim Coverage

To navigate this complex patent landscape, companies often use patent analytics tools. These tools help in categorizing patents by claims and scope concepts, making it easier to identify gaps in coverage and future design opportunities[3].

Claim Coverage Matrix

A Claim Coverage Matrix is useful for showing which patents and claims are actively protecting the intellectual property. This matrix helps in identifying where gaps or opportunities exist in the patent coverage[3].

Interactive Claim Charts

Interactive claim charts generated by software like ClaimScape® facilitate the review of patent coverage with technical experts. These charts help in determining the applicability of scope concepts to target products or methods and highlight areas needing additional claim coverage[3].

Impact on Pharmaceutical Development

These patents significantly impact the development of new antibiotic treatments. The innovation in tetracycline analogues addresses the growing need for effective antibiotics against resistant bacterial strains.

Future Directions

As patents expire, there will be opportunities for generic versions of these drugs to enter the market. However, ongoing research and development by companies like Paratek Pharmaceuticals, Inc. will continue to drive innovation in this field.

Key Takeaways

  • Therapeutic Applications: The patents cover the treatment of CABP using 9-aminomethyl minocycline compounds.
  • Dosage Forms: The compounds can be administered orally or intravenously, or in combination.
  • Clinical Success Rates: High clinical success rates are reported, often between 75% to 95%.
  • Patent Expiration Dates: Key patents expire between 2025 and 2037.
  • Patent Analytics: Tools like Claim Coverage Matrix and interactive claim charts are essential for managing the patent landscape.

Frequently Asked Questions (FAQs)

Q: What is the primary therapeutic application of 9-aminomethyl minocycline compounds? A: The primary therapeutic application is the treatment of Community-Acquired Bacterial Pneumonia (CABP).

Q: Who is the assignee for many of the patents related to these compounds? A: Paratek Pharmaceuticals, Inc. is the primary assignee.

Q: What are the typical dosage forms for these compounds? A: The compounds can be administered orally or intravenously, or in a combination of both.

Q: What are the clinical success rates reported for these compounds? A: Clinical success rates range from 75% to 95%, depending on the patient population and treatment duration.

Q: When do some of the key patents related to these compounds expire? A: Key patents expire between 2025 and 2037, with specific dates such as June 2, 2025, and October 31, 2037.

Cited Sources

  1. United States Patent and Trademark Office, "9-aminomethyl minocycline compounds and use thereof in treating community-acquired bacterial pneumonia (CABP)".
  2. Drugs.com, "Generic Nuzyra Availability".
  3. SLWIP, "Patent Analytics | Intellectual Property Law".
  4. Justia Patents, "9-aminomethyl minocycline compounds and use thereof in treating community-acquired bacterial pneumonia (CABP)".

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Drugs Protected by US Patent 9,314,475

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use Submissiondate
Paratek Pharms Inc NUZYRA omadacycline tosylate TABLET;ORAL 209816-001 Oct 2, 2018 RX Yes Yes 9,314,475 ⤷  Subscribe Y ⤷  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

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