Details for New Drug Application (NDA): 208956
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NDA 208956 describes TRIPTODUR KIT, which is a drug marketed by Azurity and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the TRIPTODUR KIT profile page.
The generic ingredient in TRIPTODUR KIT is triptorelin pamoate. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the triptorelin pamoate profile page.
The generic ingredient in TRIPTODUR KIT is triptorelin pamoate. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the triptorelin pamoate profile page.
Summary for 208956
| Tradename: | TRIPTODUR KIT |
| Applicant: | Azurity |
| Ingredient: | triptorelin pamoate |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 208956
Generic Entry Date for 208956*:
Constraining patent/regulatory exclusivity:
TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH CENTRAL PRECOCIOUS PUBERTY Dosage:
FOR SUSPENSION, EXTENDED RELEASE;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.
Medical Subject Heading (MeSH) Categories for 208956
Suppliers and Packaging for NDA: 208956
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| TRIPTODUR KIT | triptorelin pamoate | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | 208956 | NDA | Azurity Pharmaceuticals, Inc. | 24338-150 | 24338-150-20 | 1 KIT in 1 CARTON (24338-150-20) * 2 mL in 1 VIAL * 2 mL in 1 SYRINGE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Strength | EQ 22.5MG BASE/VIAL | ||||
| Approval Date: | Jun 29, 2017 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jun 29, 2024 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH CENTRAL PRECOCIOUS PUBERTY | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Jun 30, 2029 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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