Details for Patent: 9,220,745

Which drugs does patent 9,220,745 protect, and when does it expire?

Patent 9,220,745 protects GIAPREZA and is included in one NDA.

This patent has thirty-six patent family members in twenty-two countries.

Summary for Patent: 9,220,745

Title:	Angiotensin II alone or in combination for the treatment of hypotension
Abstract:	The present invention relates, inter alia, to a method comprising administering to a subject having high output shock and undergoing treatment with a catecholamine at a dose equivalent to at least about 0.2 mcg/kg/min of norepinephrine a dose of angiotensin II which is effective to raise the blood pressure of the subject to a mean arterial pressure (MAP) of about 65 mm Hg or above, and which is effective to reduce the dose of the catecholamine required to maintain a MAP of about 65 mm Hg to the equivalent of about 0.05-0.2 mcg/kg/min norepinephrine or less, or to the equivalent of about 0.05 mcg/kg/min norepinephrine or less.
Inventor(s):	Chawla; Lakhmir (McLean, VA)
Assignee:	The George Washington University, a Congressionally Not-for-Profit Corporation (Washington, DC)
Application Number:	14/575,127
Patent Claim Types: see list of patent claims	Use; Delivery;

United States Patent 9,220,745: A Detailed Analysis of Scope and Claims

Overview of the Patent

United States Patent 9,220,745, titled "Angiotensin II alone or in combination for the treatment of hypotension," was issued on December 29, 2015. This patent is assigned to The George Washington University, a Congressionally Chartered Not-for-Profit Corporation, and is a significant development in the treatment of hypotension, particularly in cases where traditional catecholamine treatments are insufficient.

Inventor and Assignee

The patent was invented by Lakhmir Chawla, a renowned expert in the field of critical care medicine. The assignee is The George Washington University, highlighting the academic and research-oriented origins of the invention.

Patent Claims

Primary Claims

The patent primarily claims methods for treating hypotension using angiotensin II, either alone or in combination with other treatments. Here are the key claims:

• Administration of Angiotensin II: The method involves administering angiotensin II to a subject with high output shock who is undergoing treatment with a catecholamine. The dose of angiotensin II is effective in raising the blood pressure of the subject to a mean arterial pressure (MAP) of about 65 mm Hg or above[1][2].

• Reduction of Catecholamine Dose: The patent also claims that the administration of angiotensin II can reduce the dose of catecholamine required to maintain a MAP of about 65 mm Hg. Specifically, the dose of catecholamine can be reduced to the equivalent of about 0.05-0.2 mcg/kg/min norepinephrine or less[1].

Specific Conditions Treated

The patent covers the treatment of various conditions, including:

• Septic Shock: Angiotensin II is used to treat patients suffering from septic shock.
• Acute Kidney Injury: The method is also applicable for treating acute kidney injury.
• Severe Hypotension: Patients with severe hypotension can benefit from this treatment.
• Cardiac Arrest: The patent includes methods for treating cardiac arrest.
• Refractory Hypotension: This is particularly significant for cases where hypotension is resistant to traditional treatments[1][2].

Scope of the Patent

Therapeutic Use of Angiotensin II

The scope of the patent extends to the therapeutic use of angiotensin II, a potent vasoconstrictor, in clinical settings. Angiotensin II is indicated for increasing blood pressure in adults with septic or other distributive shock[4].

Combination Therapy

The patent also covers the use of angiotensin II in combination with other treatments, such as catecholamines. This combination therapy is designed to enhance the efficacy of blood pressure management while reducing the side effects associated with high doses of catecholamines[1].

Variants of Angiotensin II

The patent includes isolated, synthetic, or recombinant amino acid sequences that are at least 80%, 85%, 90%, 95%, 97%, 98%, 99%, or 100% identical to the specified sequences of angiotensin II. These variant sequences can be used in place of angiotensin II in the described methods[1].

Patent Landscape

Related Patents

Several related patents have been issued, expanding on the use of angiotensin II and its variants for treating hypotension:

• Patent 9,572,856: Issued on February 21, 2017, this patent also covers the treatment of septic shock, acute kidney injury, severe hypotension, cardiac arrest, and refractory hypotension using angiotensin II[2].
• Patent 9,867,863: Issued on January 16, 2018, this patent is similar in scope, covering the treatment of various forms of hypotension with angiotensin II[2].
• Patent 11,096,983: Issued on August 24, 2021, this patent includes the use of angiotensin II, angiotensin III, or angiotensin IV for treating catecholamine-resistant hypotension[2].

Exclusivity and Generic Availability

As of the current date, there is no generic version of Giapreza (the brand name for angiotensin II) available in the United States. This indicates that the patent holder maintains exclusive marketing rights for this drug[2].

Patent Expiration Dates

The patent (US9220745B2) is set to expire on December 18, 2034. Other related patents have expiration dates ranging from 2030 to 2037, depending on the specific patent and any potential extensions or adjustments[2].

Clinical and Practical Implications

Clinical Use

The use of angiotensin II as described in the patent has significant clinical implications. It provides a new therapeutic option for patients with severe hypotension who do not respond adequately to traditional catecholamine treatments. This can improve patient outcomes by stabilizing blood pressure and reducing the need for high doses of catecholamines, which can have adverse effects[1][4].

Economic and Regulatory Considerations

The patent landscape and exclusivity period affect the economic and regulatory environment surrounding this treatment. The absence of generic alternatives means that the cost of treatment may remain higher until generic versions become available. Regulatory approvals and compliance with FDA guidelines are also crucial for the continued use and development of angiotensin II-based treatments[2].

Conclusion

United States Patent 9,220,745 represents a critical advancement in the treatment of hypotension, particularly in cases where conventional treatments are ineffective. The patent's scope includes the use of angiotensin II alone or in combination with other treatments, offering a new therapeutic approach for managing severe hypotension. Understanding the patent claims, related patents, and the broader patent landscape is essential for both clinical practitioners and industry stakeholders.

Key Takeaways

• Therapeutic Use of Angiotensin II: The patent covers the use of angiotensin II for treating hypotension, especially in cases resistant to catecholamines.
• Combination Therapy: Angiotensin II can be used in combination with catecholamines to enhance efficacy and reduce side effects.
• Variant Sequences: The patent includes variant sequences of angiotensin II that can be used in the described methods.
• Related Patents: Several related patents expand on the use of angiotensin II and its variants for treating hypotension.
• Exclusivity and Generic Availability: No generic version of Giapreza is currently available, maintaining the patent holder's exclusive marketing rights.
• Patent Expiration Dates: The patent is set to expire on December 18, 2034, with related patents expiring between 2030 and 2037.

FAQs

What is the primary use of angiotensin II as described in the patent?

The primary use of angiotensin II is to increase blood pressure in adults with septic or other distributive shock, particularly in cases where traditional catecholamine treatments are insufficient.

Can angiotensin II be used in combination with other treatments?

Yes, the patent covers the use of angiotensin II in combination with catecholamines to enhance the efficacy of blood pressure management and reduce the side effects associated with high doses of catecholamines.

Are there any generic versions of Giapreza available?

No, as of the current date, there is no generic version of Giapreza available in the United States.

What is the expiration date of the patent?

The patent (US9220745B2) is set to expire on December 18, 2034.

What conditions are treated using the methods described in the patent?

The patent covers the treatment of septic shock, acute kidney injury, severe hypotension, cardiac arrest, and refractory hypotension.

Sources

1. US9220745B2 - Angiotensin II alone or in combination for the treatment of hypotension - Google Patents
2. Generic Giapreza Availability - Drugs.com
3. Patent Claims and Patent Scope - Hoover Institution
4. Angiotensin II: Uses, Interactions, Mechanism of Action - DrugBank

Drugs Protected by US Patent 9,220,745

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-003	Dec 23, 2021		RX	Yes	Yes						TREATING HIGH OUTPUT SHOCK WITH ANGIOTENSIN II BY INCREASING MEAN ARTERIAL PRESSURE IN PATIENTS TREATED WITH CATECHOLAMINES AND REDUCING CATECHOLAMINE USE
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-003	Dec 23, 2021		RX	Yes	Yes						MAINTAINING MEAN ARTERIAL PRESSURE OF ABOUT 65 MMHG OR HIGHER WITH ANGIOTENSIN II IN SHOCK PATIENTS TREATED WITH CATECHOLAMINES AND REDUCING CATECHOLAMINE USE
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-001	Dec 21, 2017		RX	Yes	Yes						MAINTAINING MEAN ARTERIAL PRESSURE OF ABOUT 65 MMHG OR HIGHER WITH ANGIOTENSIN II IN SHOCK PATIENTS TREATED WITH CATECHOLAMINES AND REDUCING CATECHOLAMINE USE
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-001	Dec 21, 2017		RX	Yes	Yes						TREATING HIGH OUTPUT SHOCK WITH ANGIOTENSIN II BY INCREASING MEAN ARTERIAL PRESSURE IN PATIENTS TREATED WITH CATECHOLAMINES AND REDUCING CATECHOLAMINE USE

International Family Members for US Patent 9,220,745

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2014364528
Australia	2020277230
Brazil	112016013961
Canada	2933601