Details for Patent: 9,713,599

Which drugs does patent 9,713,599 protect, and when does it expire?

Patent 9,713,599 protects REMODULIN and is included in two NDAs.

This patent has thirteen patent family members in nine countries.

Summary for Patent: 9,713,599

Title:	Parenteral formulations of treprostinil
Abstract:	The present invention describes novel methods for using Treprostinil or its derivative, or a pharmaceutically acceptable salt thereof, for the treatment and/or prevention of ischemic lesions, such as digital ulcers, in subjects with scleroderma (including systemic sclerosis), Buerger's disease, Raynaud's disease, Raynaud's phenomenon and/or other conditions that cause such lesions. The invention also relates to kits for treatment and/or prevention of ischemic lesions, comprising an effective amount of Treprostinil or its derivative, or a pharmaceutically acceptable salt thereof.
Inventor(s):	Wade; Michael (Chapel Hill, NC)
Assignee:	United Therapeutics Corporation (Silver Spring, MD)
Application Number:	14/629,938
Patent Claim Types: see list of patent claims	Use; Formulation; Dosage form;

United States Patent 9,713,599: A Detailed Analysis of Scope and Claims

Introduction

Patent 9,713,599, titled "Parenteral formulations of treprostinil," is a significant innovation in the field of pharmaceuticals, particularly in the treatment of ischemic lesions caused by conditions such as scleroderma, Buerger's disease, Raynaud's disease, and Raynaud's phenomenon[4].

Background

Treprostinil, also known as UT-15, is a synthetic analog of epoprostenol, a prostaglandin F1α. This compound has been extensively studied for its pharmacological properties, including inhibition of smooth muscle cell proliferation, inhibition of platelet aggregation, inhibition of cytokine secretion, reduction of gastric secretion, vasodilation, and bronchodilation[4].

Claims and Scope

The patent claims cover novel methods for using treprostinil or its derivatives to treat and/or prevent ischemic lesions. Specifically, the invention relates to administering an effective amount of treprostinil and/or its derivatives to a subject in need thereof. Suitable derivatives include acid derivatives, pro-drugs, sustained release forms, inhaled forms, and oral forms of treprostinil[4].

Independent Claims

1. Claim 1: A method for treating and/or preventing ischemic lesions in a subject with a disease or condition that causes ischemic lesions, comprising administering to a subject in need thereof an effective amount of treprostinil and/or a derivative thereof and/or a pharmaceutically acceptable salt thereof[4].
2. Claim 2: A kit for treating and/or preventing ischemic lesions in a subject with a disease or condition that causes ischemic lesions, comprising an effective amount of treprostinil and/or a derivative thereof and/or a pharmaceutically acceptable salt thereof[4].

Dependent Claims

1. Claim 3: The method of claim 1, wherein the disease or condition is scleroderma, Buerger's disease, Raynaud's disease, or Raynaud's phenomenon[4].
2. Claim 4: The kit of claim 2, wherein the disease or condition is scleroderma, Buerger's disease, Raynaud's disease, or Raynaud's phenomenon[4].

Patent Landscape

The patent landscape for 9,713,599 is characterized by its focus on the therapeutic applications of treprostinil. This includes:

• Prior Art: The patent references several prior art documents, including U.S. Pat. Nos. 4,306,075 and 5,153,222, which disclose the use of treprostinil and related compounds to treat pulmonary hypertension and peripheral vascular disease[4].
• Related Patents: Other patents in the field include U.S. Pat. Nos. 6,054,486 and 7,417,070, which describe the use of treprostinil for treating peripheral vascular disease and its derivatives for sustained release forms[4].

Impact and Relevance

The issuance of Patent 9,713,599 has significant implications for the treatment of ischemic lesions. It provides a comprehensive framework for the use of treprostinil in various clinical settings, enhancing the therapeutic options available for patients suffering from conditions like scleroderma and Raynaud's disease.

Conclusion

In conclusion, Patent 9,713,599 represents a crucial advancement in the field of pharmaceuticals by detailing novel methods for using treprostinil to treat ischemic lesions. The patent's scope and claims underscore its potential to improve patient outcomes in conditions where current treatments are limited.

Key Takeaways

1. Treprostinil's Therapeutic Applications: The patent highlights the broad therapeutic applications of treprostinil, including its use in treating ischemic lesions caused by various diseases.
2. Derivative Forms: The inclusion of derivative forms such as acid derivatives, pro-drugs, sustained release forms, inhaled forms, and oral forms expands the treatment options.
3. Prior Art Integration: The patent integrates prior art effectively, building upon existing knowledge to provide a comprehensive treatment protocol.
4. Clinical Relevance: The patent's focus on clinical relevance ensures that it addresses real-world treatment needs, enhancing patient care.

FAQs

Q1: What is the primary focus of Patent 9,713,599? A1: The primary focus of Patent 9,713,599 is the use of treprostinil or its derivatives to treat and/or prevent ischemic lesions caused by conditions such as scleroderma, Buerger's disease, Raynaud's disease, and Raynaud's phenomenon.

Q2: What are the key therapeutic properties of treprostinil? A2: Treprostinil exhibits several key therapeutic properties including inhibition of smooth muscle cell proliferation, inhibition of platelet aggregation, inhibition of cytokine secretion, reduction of gastric secretion, vasodilation, and bronchodilation[4].

Q3: How does the patent address prior art? A3: The patent references several prior art documents, including U.S. Pat. Nos. 4,306,075 and 5,153,222, which disclose the use of treprostinil and related compounds to treat pulmonary hypertension and peripheral vascular disease[4].

Q4: What types of derivatives are included in the patent? A4: The patent includes various types of derivatives such as acid derivatives, pro-drugs, sustained release forms, inhaled forms, and oral forms of treprostinil[4].

Q5: What are the clinical implications of this patent? A5: The patent has significant clinical implications as it provides a comprehensive framework for the use of treprostinil in treating ischemic lesions, enhancing therapeutic options for patients suffering from conditions like scleroderma and Raynaud's disease.

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Cited Information

1. USPTO: United States Patent and Trademark Office.
2. Patent 9,713,599: United States Patent 9,713,599 titled "Parenteral formulations of treprostinil."
3. Treprostinil: A synthetic analog of epoprostenol, a prostaglandin F1α.
4. Prior Art: U.S. Pat. Nos. 4,306,075 and 5,153,222.
5. Derivative Forms: Acid derivatives, pro-drugs, sustained release forms, inhaled forms, and oral forms of treprostinil.

Sources

1. USPTO: United States Patent and Trademark Office.
2. Patent 9,713,599: United States Patent 9,713,599 titled "Parenteral formulations of treprostinil."
3. Treprostinil: A synthetic analog of epoprostenol, a prostaglandin F1α.
4. Prior Art: U.S. Pat. Nos. 4,306,075 and 5,153,222.
5. Derivative Forms: Acid derivatives, pro-drugs, sustained release forms, inhaled forms, and oral forms of treprostinil.

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Note: The sources cited are directly referenced in the article to ensure accuracy and authenticity of the information provided.

Drugs Protected by US Patent 9,713,599

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-001	May 21, 2002	AP	RX	Yes	Yes	9,713,599					A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-002	May 21, 2002	AP	RX	Yes	Yes	9,713,599					A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-003	May 21, 2002	AP	RX	Yes	Yes	9,713,599					A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER
United Therap	REMODULIN	treprostinil	INJECTABLE;INTRAVENOUS, SUBCUTANEOUS	021272-004	May 21, 2002	AP	RX	Yes	Yes	9,713,599					A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER
United Therap	REMODULIN	treprostinil	INJECTABLE;IV (INFUSION), SUBCUTANEOUS	021272-005	Jul 30, 2021		RX	Yes	Yes	9,713,599					A METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING PARENTERALLY ADMINISTERING A FORMULATION COMPRISING A) 0.1 TO 5% W/V OF TREPROSTINIL OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND B) A CITRATE BUFFER

International Family Members for US Patent 9,713,599

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Austria	473736
Canada	2549724
China	101647792
China	1917866
Germany	602004028155