GIAPREZA Drug Patent Profile

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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 ten patents protecting this drug and one Paragraph IV challenge.

This drug has forty-four patent family members in twenty-three 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.

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

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Summary for GIAPREZA

International Patents:	44
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	6
Patent Applications:	7,510
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for GIAPREZA
What excipients (inactive ingredients) are in GIAPREZA?	GIAPREZA excipients list
DailyMed Link:	GIAPREZA at DailyMed

Drug patent expirations by year for GIAPREZA

Recent Clinical Trials for GIAPREZA

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

Sponsor	Phase
National Center for Advancing Translational Science (NCATS)	Phase 4
University of New Mexico	Phase 4
University of California, Los Angeles	Phase 2

See all GIAPREZA clinical trials

Pharmacology for GIAPREZA

Drug Class	Vasoconstrictor
Physiological Effect	Vasoconstriction

Anatomical Therapeutic Chemical (ATC) Classes for GIAPREZA

C01CX	Other cardiac stimulants
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

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 fifteen US patents and one FDA Regulatory Exclusivity.

Patents protecting GIAPREZA

Angiotensin II alone or in combination for the treatment of hypotension
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: MAINTAINING MEAN ARTERIAL PRESSURE OF ABOUT 65 MMHG OR ABOVE WITH ABOUT 1 NG/KG/MIN TO ABOUT 40 NG/KG/MIN ANGIOTENSIN II IN HYPOTENSIVE PATIENTS TREATED WITH VASOPRESSIN OR A VASOPRESSIN ANALOGUE AND REDUCING VASOPRESSIN OR VASOPRESSIN ANALOGUE USE

Method of treating low blood pressure
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATING HYPOTENSION WITH ABOUT 20 NG/KG/MIN TO ABOUT 40 NG/KG/MIN ANGIOTENSIN II IN A HUMAN SUBJECT HAVING SEPTIC SHOCK

Angiotensin II alone or in combination for the treatment of hypotension
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATING LOW BLOOD PRESSURE WITH ANGIOTENSIN II AT AN INITIAL RATE OF ABOUT 20 NG/KG/MIN AND TITRATING DOWN TO ACHIEVE AND/OR MAINTAIN A MAP OF ABOUT 65 MM HG OR ABOVE

Method of treating low blood pressure
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATING LOW BLOOD PRESSURE WITH ANGIOTENSIN II WITH AN INITIAL RATE OF ABOUT 5 NG/KG/MIN TO ABOUT 20 NG/KG/MIN IN A SUBJECT HAVING REFRACTORY HYPOTENSION OR SEVERE HYPOTENSION, AND TITRATING THE RATE UP

Method of treating low blood pressure
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: INCREASING BLOOD PRESSURE WITH A RATE OF ABOUT 20 NG/KG/MIN TO ABOUT 40 NG/KG/MIN ANGIOTENSIN II IN A HUMAN SUBJECT HAVING SEPTIC SHOCK

Method of treating low blood pressure
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: INCREASING BLOOD PRESSURE WITH AN INITIAL RATE OF ABOUT 20 NG/KG/MIN ANGIOTENSIN II IN A HUMAN SUBJECT HAVING SEPTIC SHOCK, AND TITRATING THE RATE UP.

Angiotensin II alone or in combination for the treatment of hypotension
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATING SEPTIC SHOCK WITH ANGIOTENSIN II

Angiotensin II alone or in combination for the treatment of hypotension
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATING DISTRIBUTIVE SHOCK WITH ANGIOTENSIN II

Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATING HYPOTENSION WITH ANGIOTENSIN II IN A PATIENT RECEIVING AN ANGIOTENSIN CONVERTING ENZYME INHIBITOR

Angiotensin II alone or in combination for the treatment of hypotension
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATING HIGH OUTPUT SHOCK WITH ANGIOTENSIN II BY INCREASING MEAN ARTERIAL PRESSURE IN PATIENTS TREATED WITH CATECHOLAMINES AND REDUCING CATECHOLAMINE USE

Angiotensin II alone or in combination for the treatment of hypotension
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: MAINTAINING MEAN ARTERIAL PRESSURE OF ABOUT 65 MMHG OR HIGHER WITH ANGIOTENSIN II IN SHOCK PATIENTS TREATED WITH CATECHOLAMINES AND REDUCING CATECHOLAMINE USE

Method of treating low blood pressure
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATING REFRACTORY HYPOTENSION WITH ABOUT 20 NG/KG/MIN ANGIOTENSIN II IN A PATIENT RECEIVING VASOPRESSOR

Method of treating low blood pressure
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATING REFRACTORY HYPOTENSION WITH ABOUT 5 NG/KG/MIN TO ABOUT 20 NG/KG/MIN ANGIOTENSIN II IN A PATIENT RECEIVING VASOPRESSOR

FDA Regulatory Exclusivity protecting GIAPREZA

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-002	Dec 21, 2017		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-001	Dec 21, 2017		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-002	Dec 21, 2017		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-003	Dec 23, 2021		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-001	Dec 21, 2017		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
La Jolla Pharma	GIAPREZA	angiotensin ii acetate	SOLUTION;INTRAVENOUS	209360-001	Dec 21, 2017		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for GIAPREZA

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

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Country	Patent Number	Title	Estimated Expiration
Serbia	59804	ANGIOTENZIN II U KOMBINACIJI ZA LEČENJE HIPOTENZIJE (ANGIOTENSIN II IN COMBINATION FOR THE TREATMENT OF HYPOTENSION)	⤷ Try a Trial
Japan	2019214610	低血圧治療のための単独または併用使用されるアンギオテンシンＩＩ (ANGIOTENSIN II ALONE OR IN COMBINATION FOR TREATMENT OF HYPOTENSION)	⤷ Try a Trial
Japan	6824739		⤷ Try a Trial
China	112546197	血管紧张素II单独或以组合方式用于治疗低血压 (Angiotensin ll alone or in combination for the treatment of hypotension)	⤷ Try a Trial
South Korea	20220028125	저혈압의 치료를 위한 안지오텐신 II 단독 또는 조합 (II ANGIOTENSIN II ALONE OR IN COMBINATION FOR THE TREATMENT OF HYPOTENSION)	⤷ Try a Trial
South Korea	102399383		⤷ Try a Trial
Taiwan	201733610	Methods for administering angiotensin II	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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