GIAPREZA Drug Patent Profile

Which patents cover Giapreza, and what generic alternatives are available?

Giapreza is a drug marketed by La Jolla Pharma and is included in one NDA. There are eleven patents protecting this drug and one Paragraph IV challenge.

This drug has fifty patent family members in twenty-four countries.

The generic ingredient in GIAPREZA is angiotensin ii acetate. There are five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the angiotensin ii acetate profile page.

DrugPatentWatch^® Generic Entry Outlook for Giapreza

Giapreza was eligible for patent challenges on December 21, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 16, 2029. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for GIAPREZA

International Patents:	50
US Patents:	11
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	8
Patent Applications:	7,119
Drug Prices:	Drug price information for GIAPREZA
What excipients (inactive ingredients) are in GIAPREZA?	GIAPREZA excipients list
DailyMed Link:	GIAPREZA at DailyMed

See drug prices for GIAPREZA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for GIAPREZA

Constraining patent/regulatory exclusivity:

10,500,247

NDA:

209360

Dosage:

SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for GIAPREZA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Kingman Regional Medical Center	Phase 4
National Center for Advancing Translational Science (NCATS)	Phase 4
University of New Mexico	Phase 4

See all GIAPREZA clinical trials

Pharmacology for GIAPREZA

Drug Class	Vasoconstrictor
Physiological Effect	Vasoconstriction

Paragraph IV (Patent) Challenges for GIAPREZA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
GIAPREZA	Injection	angiotensin ii acetate	2.5 mg/mL	209360	1	2021-12-21

US Patents and Regulatory Information for GIAPREZA

GIAPREZA is protected by sixteen US patents.

This potential generic entry date is based on patent 10,500,247.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-002	Dec 21, 2017		DISCN	Yes	No	11,219,662
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-001	Dec 21, 2017		RX	Yes	Yes	11,219,662
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-002	Dec 21, 2017		DISCN	Yes	No	9,867,863
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-001	Dec 21, 2017		RX	Yes	Yes	11,096,983
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-003	Dec 23, 2021		RX	Yes	Yes	11,559,559

International Patents for GIAPREZA

See the table below for patents covering GIAPREZA around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2973280
Cyprus	1122604
China	106061493	血管紧张素II单独或以组合方式用于治疗低血压 (Angiotensin ii alone or in combination for the treatment of hypotension)
Australia	2020277230	Angiotensin ll alone or in combination for the treatment of hypotension
Eurasian Patent Organization	037823	СПОСОБ ЛЕЧЕНИЯ СУБЪЕКТА, ИСПЫТЫВАЮЩЕГО ИНТЕНСИВНЫЙ ШОК И ПОЛУЧАЮЩЕГО ЛЕЧЕНИЕ КАТЕХОЛАМИНОМ ИЛИ ВАЗОПРЕССИНОМ (METHOD FOR THE TREATMENT OF A SUBJECT HAVING HIGH OUTPUT SHOCK AND UNDERGOING TREATMENT WITH CATECHOLAMINE OR VASOPRESSIN)

Market Dynamics and Financial Trajectory for GIAPREZA

Introduction to GIAPREZA

GIAPREZA (angiotensin II) is a vasoconstrictor approved by the U.S. Food and Drug Administration (FDA) for the treatment of septic or other distributive shock in adults. This drug is crucial for increasing blood pressure in critically ill patients who do not respond adequately to conventional therapies[1].

Approval and Clinical Significance

GIAPREZA was approved by the FDA in December 2017, following a Priority Review that highlighted its potential to significantly improve the treatment of serious conditions. Clinical trials, such as the ATHOS-3 study, demonstrated that GIAPREZA effectively increased blood pressure and reduced the need for other vasopressors in patients with shock. The drug showed rapid efficacy, with 70% of patients achieving target mean arterial pressure (MAP) within the first 30 minutes of treatment[1][3].

Market Performance

Sales Growth

Since its approval, GIAPREZA has shown consistent growth in sales. For the three months ended March 31, 2022, GIAPREZA U.S. net product sales were $7.7 million, a 13% increase from the same period in 2021. This trend continued, with GIAPREZA U.S. net product sales reaching $9.2 million for the three months ended December 31, 2021, and $33.4 million for the twelve months ended December 31, 2021, representing a 14% increase from 2020[2][4].

Recent Financials

In the third quarter of 2024, GIAPREZA contributed significantly to Innoviva Specialty Therapeutics' (IST) portfolio, with U.S. net product sales of $13.1 million. This reflects a strong performance within IST's marketed portfolio, which saw a 68% year-over-year increase in net product sales[5].

Corporate Progress and Strategy

La Jolla Pharmaceutical Company, the original developer and marketer of GIAPREZA, has focused on growing the drug's franchise. The company has reported positive net cash provided by operating activities, indicating a stable financial foundation. Larry Edwards, President and Chief Executive Officer of La Jolla, emphasized the company's commitment to increasing operating cash flow and expanding the GIAPREZA and XERAVA franchises[2].

Safety and Efficacy Considerations

While GIAPREZA has demonstrated significant efficacy in treating hypotensive patients, it also comes with important safety considerations. The drug can cause dangerous blood clots, including deep venous thrombosis, and thus requires prophylactic treatment for blood clots. Despite these risks, the overall benefit of GIAPREZA in rapidly stabilizing blood pressure and reducing mortality has been a key factor in its adoption[1][3].

Competitive Landscape

In the market for critical care therapies, GIAPREZA occupies a unique niche due to its rapid action and effectiveness in patients with septic or distributive shock. Its approval and subsequent sales growth indicate a strong market demand for innovative treatments that can improve outcomes in critically ill patients.

Financial Trajectory

The financial performance of GIAPREZA has been steadily improving since its approval. Here are some key financial highlights:

• Quarterly Sales: GIAPREZA U.S. net product sales have consistently increased, with $7.7 million in Q1 2022 and $9.2 million in Q4 2021[2][4].
• Annual Sales: For the twelve months ended December 31, 2021, GIAPREZA U.S. net product sales were $33.4 million, up 14% from 2020[4].
• Recent Performance: In the third quarter of 2024, GIAPREZA sales contributed $13.1 million to IST's portfolio, reflecting a strong year-over-year growth[5].

Future Outlook

Given its clinical efficacy and growing market presence, GIAPREZA is poised for continued success. The drug's ability to rapidly stabilize blood pressure and reduce the need for other vasopressors makes it a valuable asset in critical care settings. As La Jolla Pharmaceutical Company and its partners continue to focus on expanding the drug's franchise, we can expect further growth in sales and market penetration.

Key Takeaways

• Approval and Clinical Significance: GIAPREZA was approved by the FDA in 2017 for treating septic or distributive shock.
• Sales Growth: Consistent increase in U.S. net product sales, with $7.7 million in Q1 2022 and $33.4 million in 2021.
• Safety and Efficacy: Rapid action in stabilizing blood pressure, but with risks of blood clots.
• Corporate Strategy: Focus on growing the GIAPREZA franchise and increasing operating cash flow.
• Financial Trajectory: Steady improvement in sales, with significant year-over-year growth.

FAQs

What is GIAPREZA used for?

GIAPREZA (angiotensin II) is used to increase blood pressure in adults with septic or other distributive shock.

When was GIAPREZA approved by the FDA?

GIAPREZA was approved by the FDA on December 21, 2017.

What are the key benefits of GIAPREZA in clinical settings?

GIAPREZA rapidly stabilizes blood pressure and reduces the need for other vasopressors, improving outcomes in critically ill patients.

What are the potential risks associated with GIAPREZA?

GIAPREZA can cause dangerous blood clots, including deep venous thrombosis, and requires prophylactic treatment for blood clots.

How has GIAPREZA performed financially since its approval?

GIAPREZA has shown consistent growth in sales, with U.S. net product sales increasing to $33.4 million in 2021 and $13.1 million in the third quarter of 2024.

Sources

1. FDA Press Announcement: FDA approves drug to treat dangerously low blood pressure.
2. Business Wire: La Jolla Pharmaceutical Company Announces Financial Results for the Three Months Ended March 31, 2022.
3. GIAPREZA Official Website: Efficacy and Trial Design | GIAPREZA® (angiotensin II).
4. Business Wire: La Jolla Pharmaceutical Company Announces Financial Results for the Three and Twelve Months Ended December 31, 2021.
5. Business Wire: Innoviva Reports Third Quarter 2024 Financial Results.

Last updated: 2024-12-16