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Inhaled Medications01:23

Inhaled Medications

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Inhaled medications are crucial for managing chronic obstructive pulmonary disease (COPD) and asthma. They are essential for effective treatment and control, ensuring optimal respiratory health and well-being. Inhaled medication delivers drugs directly to the lungs, providing a rapid onset of action and reducing systemic side effects compared to oral or injectable medications. Three primary types of inhalation devices are used to administer these medications: nebulizers, metered-dose inhalers...
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Drug Delivery: Miscellaneous Routes01:22

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Drug delivery methods like oral inhalation, nasal sprays, transdermal patches, eye drops, intravitreal injection,  and rectal administration provide localized effects with reduced toxicity.
Oral inhalation and nasal sprays swiftly transfer drugs across the respiratory epithelium's mucosal layer. Inhaled glucocorticoids and bronchodilators directly target lung conditions such as asthma, while fluticasone nasal spray mitigates allergic rhinitis.
Transdermal patches transport drugs...
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Additional Routes of Drug Administration01:18

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Choosing the appropriate route of drug administration is significantly influenced by two key factors: the therapeutic objectives and the inherent properties of the drug being used.
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Oxygen Delivering System II: Venturi Mask and Transtracheal Oxygen01:16

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Oxygen therapy is a pivotal aspect of medical care, particularly for patients with respiratory ailments. Two prominent oxygen-delivering systems include the Venturi mask and the transtracheal oxygen catheter.
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Patenting Strategies on Inhaler Delivery Devices.

Brandon J Demkowicz1, S Sean Tu2, Aaron S Kesselheim3

  • 1Harvard University; Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA.

Chest
|February 26, 2023
PubMed
Summary
This summary is machine-generated.

Brand-name inhaler manufacturers use device patents to extend market exclusivity, delaying generic competition. This study found device patents added a median of 5.5 years of protection for asthma and COPD inhalers, increasing costs for patients.

Keywords:
COPDFood and Drug Administrationantitrust lawasthmainhalerspatents

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Area of Science:

  • Pharmaceutical policy and intellectual property law
  • Respiratory medicine and drug delivery systems

Background:

  • Patients with asthma and chronic obstructive pulmonary disease (COPD) depend on inhalers for symptom management.
  • High costs of these essential medications are partly attributed to extensive patenting of brand-name inhalers, including their delivery devices.
  • Antitrust scrutiny is increasing regarding the listing of device patents with the U.S. Food and Drug Administration (FDA), especially when patents do not cover active ingredients.

Purpose of the Study:

  • To investigate how manufacturers have utilized device patents to maintain market exclusivity for brand-name inhalers.
  • To quantify the impact of device patents on extending market protection for asthma and COPD inhalers.

Main Methods:

  • Analysis of brand-name inhaler patents approved between 1986 and 2020 using the FDA's Orange Book.
  • Extraction of patent data from LexisNexis TotalPatent One and Google Patents.
  • Examination of device patents for mentions of active ingredients or specific features linking them to the drug product; calculation of extended market protection duration.

Main Results:

  • Of 53 brand-name inhalers approved (1986-2020), 39 had at least one device patent, totaling 137 distinct patents (49% of all listed patents).
  • A significant majority of device patents (77%) did not mention active ingredients, and 72% lacked specified features linking them to the drug.
  • Device patents extended market protection by a median of 5.5 years beyond the last non-device patent for the 39 affected inhalers.

Conclusions:

  • Device patents are frequently used to extend market exclusivity for asthma and COPD inhalers, often without direct claims on active ingredients.
  • This practice contributes to delayed generic competition and higher medication costs for patients.
  • Patent and regulatory reforms are necessary to foster generic competition and improve patient access to affordable respiratory medications.