Details for New Drug Application (NDA): 200677
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The generic ingredient in SIGNIFOR is pasireotide pamoate. One supplier is listed for this compound. Additional details are available on the pasireotide pamoate profile page.
Summary for 200677
Tradename: | SIGNIFOR |
Applicant: | Recordati Rare |
Ingredient: | pasireotide diaspartate |
Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 200677
Generic Entry Date for 200677*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;SUBCUTANEOUS |
*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: 200677
Mechanism of Action | Somatostatin Receptor Agonists |
Suppliers and Packaging for NDA: 200677
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
SIGNIFOR | pasireotide diaspartate | SOLUTION;SUBCUTANEOUS | 200677 | NDA | Recordati Rare Diseases, Inc. | 55292-131 | 55292-131-60 | 60 PACKAGE in 1 BOX (55292-131-60) / 6 AMPULE in 1 PACKAGE (55292-131-06) / 1 mL in 1 AMPULE (55292-131-01) |
SIGNIFOR | pasireotide diaspartate | SOLUTION;SUBCUTANEOUS | 200677 | NDA | Recordati Rare Diseases, Inc. | 55292-132 | 55292-132-60 | 60 PACKAGE in 1 BOX (55292-132-60) / 6 AMPULE in 1 PACKAGE (55292-132-06) / 1 mL in 1 AMPULE (55292-132-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML) | ||||
Approval Date: | Dec 14, 2012 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Dec 14, 2026 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Patent: | ⤷ Sign Up | Patent Expiration: | Dec 27, 2025 | Product Flag? | Y | Substance Flag? | Y | Delist Request? |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML) | ||||
Approval Date: | Dec 14, 2012 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Dec 14, 2026 | Product Flag? | Y | Substance Flag? | Y | Delist Request? |
Expired US Patents for NDA 200677
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Recordati Rare | SIGNIFOR | pasireotide diaspartate | SOLUTION;SUBCUTANEOUS | 200677-001 | Dec 14, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Recordati Rare | SIGNIFOR | pasireotide diaspartate | SOLUTION;SUBCUTANEOUS | 200677-003 | Dec 14, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Recordati Rare | SIGNIFOR | pasireotide diaspartate | SOLUTION;SUBCUTANEOUS | 200677-002 | Dec 14, 2012 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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