Details for New Drug Application (NDA): 200677
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NDA 200677 describes SIGNIFOR, which is a drug marketed by Recordati Rare and is included in two NDAs. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the SIGNIFOR profile page.
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.
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: | 7,473,761 | Patent Expiration: | Dec 14, 2026 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | 8,299,209 | 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: | 7,473,761 | 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 | 6,225,284 | ⤷ Get Started Free |
| Recordati Rare | SIGNIFOR | pasireotide diaspartate | SOLUTION;SUBCUTANEOUS | 200677-003 | Dec 14, 2012 | 6,225,284 | ⤷ Get Started Free |
| Recordati Rare | SIGNIFOR | pasireotide diaspartate | SOLUTION;SUBCUTANEOUS | 200677-002 | Dec 14, 2012 | 6,225,284 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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