Treprostinil Administration by Inhalation: A Detailed Analysis of U.S. Patent 10,376,525
Introduction
Treprostinil, a prostacyclin analogue, is a medication used to treat pulmonary hypertension and other related conditions. U.S. Patent 10,376,525, assigned to United Therapeutics Corporation, focuses on the administration of treprostinil via inhalation, a method that enhances patient autonomy and efficacy. Here, we delve into the scope, claims, and patent landscape surrounding this innovation.
Background of Treprostinil
Treprostinil is a small molecule drug approved for the treatment of pulmonary arterial hypertension (PAH) and, more recently, for the treatment of pulmonary hypertension associated with interstitial lung disease (ILD)[1][4].
Patent Overview: U.S. Patent 10,376,525
Issuance and Assignee
U.S. Patent 10,376,525 was issued on August 13, 2019, and is assigned to United Therapeutics Corporation. The inventors include Horst Olschewski, Robert Roscigno, Lewis J. Rubin, Thomas Schmehl, Werner Seeger, Carl Sterritt, and Robert Voswinckel[2].
Claims and Scope
The patent primarily covers the administration of treprostinil using a metered dose inhaler (MDI). Here are the key aspects of the claims:
Administration Method
The patent describes a method for administering treprostinil through inhalation, which provides patients with greater autonomy in managing their condition. This method involves using a metered dose inhaler, which ensures a precise and consistent dosage of the medication[2].
Pharmaceutical Formulation
The patent includes claims related to the pharmaceutical formulation of treprostinil suitable for inhalation. This formulation is designed to be delivered via an MDI, ensuring effective treatment of pulmonary hypertension and related conditions[2].
Kits and Devices
The patent also covers kits that include a metered dose inhaler containing the treprostinil formulation. These kits are designed to make the treatment more accessible and user-friendly for patients[2].
Key Claims
- Claim 1: A method for treating pulmonary hypertension, comprising administering treprostinil via a metered dose inhaler.
- Claim 2: A pharmaceutical formulation of treprostinil for inhalation, comprising treprostinil and a propellant.
- Claim 3: A kit comprising a metered dose inhaler containing the treprostinil formulation and instructions for use.
Patent Expiration Dates
The patent is set to expire on May 14, 2027. This expiration date is crucial as it marks the end of the exclusive rights granted to United Therapeutics Corporation for this specific method of treprostinil administration[2].
Related Patents and Exclusivities
Related Patents
Several other patents related to treprostinil administration and formulation are held by United Therapeutics Corporation. These include patents such as 9,339,507, 9,358,240, and 11,723,887, which also cover various aspects of treprostinil administration via inhalation and other methods[2].
Exclusivities
In addition to patent protection, treprostinil has exclusivity rights granted by the FDA. For instance, an exclusivity period for the treatment of pulmonary hypertension associated with interstitial lung disease expires on March 31, 2024. These exclusivities run concurrently with the patent protection, further safeguarding the proprietary rights of the drug[2].
Impact on Patient Care
The method described in U.S. Patent 10,376,525 significantly enhances patient care by:
- Improving Autonomy: Patients can administer the medication independently using a metered dose inhaler, reducing the need for continuous medical supervision.
- Enhancing Efficacy: The precise dosing and consistent delivery of treprostinil via inhalation improve the therapeutic outcomes for patients with pulmonary hypertension and ILD[1][2].
Market and Generic Availability
As of the current date, there is no generic version of Tyvaso (the brand name for treprostinil) available in the United States. The lack of generic alternatives is due to the ongoing patent and exclusivity protections[2].
Conclusion
U.S. Patent 10,376,525 is a significant innovation in the treatment of pulmonary hypertension and related conditions, offering patients a more autonomous and effective method of administering treprostinil. The patent's claims and scope are well-defined, covering the administration method, pharmaceutical formulation, and associated kits. With its expiration date in 2027, this patent continues to protect the proprietary rights of United Therapeutics Corporation while enhancing patient care.
Key Takeaways
- Inhalation Method: Treprostinil can be administered effectively via a metered dose inhaler.
- Pharmaceutical Formulation: The patent covers a specific formulation of treprostinil for inhalation.
- Kits and Devices: Kits including the MDI and instructions are part of the patent.
- Patent Expiration: The patent expires on May 14, 2027.
- Related Patents and Exclusivities: Other patents and FDA-granted exclusivities further protect the drug.
FAQs
Q: What is the primary focus of U.S. Patent 10,376,525?
A: The primary focus is the administration of treprostinil via a metered dose inhaler for treating pulmonary hypertension.
Q: Who is the assignee of U.S. Patent 10,376,525?
A: The assignee is United Therapeutics Corporation.
Q: What is the expiration date of U.S. Patent 10,376,525?
A: The patent expires on May 14, 2027.
Q: Is there a generic version of Tyvaso available?
A: No, there is currently no generic version of Tyvaso available in the United States.
Q: How does the inhalation method improve patient care?
A: The inhalation method enhances patient autonomy and efficacy by providing precise and consistent dosing of treprostinil.
Sources
- Google Patents: Treprostinil for use in the treatment of interstitial lung disease.
- Drugs.com: Generic Tyvaso Availability.
- SSRN: Patent Claims and Patent Scope.
- DrugBank: Treprostinil: Uses, Interactions, Mechanism of Action.
- Unified Patents: WO-2002034318-A2 - Inhaler.
