Details for New Drug Application (NDA): 203255
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NDA 203255 describes SIGNIFOR LAR KIT, which is a drug marketed by Recordati Rare and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the SIGNIFOR LAR KIT profile page.
The generic ingredient in SIGNIFOR LAR KIT 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 LAR KIT is pasireotide pamoate. One supplier is listed for this compound. Additional details are available on the pasireotide pamoate profile page.
Summary for 203255
| Tradename: | SIGNIFOR LAR KIT |
| Applicant: | Recordati Rare |
| Ingredient: | pasireotide pamoate |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 203255
Generic Entry Date for 203255*:
Constraining patent/regulatory exclusivity:
Dosage:
FOR SUSPENSION;INTRAMUSCULAR |
*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.
Suppliers and Packaging for NDA: 203255
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| SIGNIFOR LAR KIT | pasireotide pamoate | FOR SUSPENSION;INTRAMUSCULAR | 203255 | NDA | Recordati Rare Diseases, Inc. | 55292-139 | 55292-139-01 | 1 KIT in 1 KIT (55292-139-01) * 6 mL in 1 VIAL, SINGLE-USE (55292-134-01) * 2 mL in 1 SYRINGE |
| SIGNIFOR LAR KIT | pasireotide pamoate | FOR SUSPENSION;INTRAMUSCULAR | 203255 | NDA | Recordati Rare Diseases, Inc. | 55292-140 | 55292-140-01 | 1 KIT in 1 KIT (55292-140-01) * 6 mL in 1 VIAL, SINGLE-USE (55292-135-01) * 2 mL in 1 SYRINGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;INTRAMUSCULAR | Strength | EQ 20MG BASE/VIAL | ||||
| Approval Date: | Dec 15, 2014 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 29, 2025 | ||||||||
| Regulatory Exclusivity Use: | INDICATED FOR TREATMENT OF PATIENTS WITH CUSHING'S DISEASE FOR WHOM PITUITARY SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Dec 14, 2026 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Try a Trial | Patent Expiration: | Oct 25, 2026 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 203255
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Recordati Rare | SIGNIFOR LAR KIT | pasireotide pamoate | FOR SUSPENSION;INTRAMUSCULAR | 203255-002 | Dec 15, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
| Recordati Rare | SIGNIFOR LAR KIT | pasireotide pamoate | FOR SUSPENSION;INTRAMUSCULAR | 203255-001 | Dec 15, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
| Recordati Rare | SIGNIFOR LAR KIT | pasireotide pamoate | FOR SUSPENSION;INTRAMUSCULAR | 203255-002 | Dec 15, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
| Recordati Rare | SIGNIFOR LAR KIT | pasireotide pamoate | FOR SUSPENSION;INTRAMUSCULAR | 203255-001 | Dec 15, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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