Details for New Drug Application (NDA): 209360
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NDA 209360 describes GIAPREZA, which is a drug marketed by La Jolla Pharma and is included in one NDA. It is available from one supplier. There are eleven patents protecting this drug. Additional details are available on the GIAPREZA profile page.
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.
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.
Summary for 209360
| Tradename: | GIAPREZA |
| Applicant: | La Jolla Pharma |
| Ingredient: | angiotensin ii acetate |
| Patents: | 11 |
| Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 209360
Generic Entry Date for 209360*:
Constraining patent/regulatory exclusivity:
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.
Pharmacology for NDA: 209360
| Physiological Effect | Vasoconstriction |
Medical Subject Heading (MeSH) Categories for 209360
Suppliers and Packaging for NDA: 209360
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GIAPREZA | angiotensin ii acetate | SOLUTION;INTRAVENOUS | 209360 | NDA | La Jolla Pharmaceutical Company | 68547-005 | 68547-005-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (68547-005-01) / 1 mL in 1 VIAL, SINGLE-DOSE |
| GIAPREZA | angiotensin ii acetate | SOLUTION;INTRAVENOUS | 209360 | NDA | La Jolla Pharmaceutical Company | 68547-501 | 68547-501-02 | 1 VIAL, SINGLE-DOSE in 1 CARTON (68547-501-02) / 1 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML) | ||||
| Approval Date: | Dec 21, 2017 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Dec 18, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| 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 | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Dec 16, 2029 | Product Flag? | Substance Flag? | Delist Request? | |||
| 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 | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Dec 18, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| 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 | ||||||||
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