Details for New Drug Application (NDA): 203441
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NDA 203441 describes GATTEX KIT, which is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the GATTEX KIT profile page.
The generic ingredient in GATTEX KIT is teduglutide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the teduglutide profile page.
The generic ingredient in GATTEX KIT is teduglutide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the teduglutide profile page.
Summary for 203441
| Tradename: | GATTEX KIT |
| Applicant: | Takeda Pharms Usa |
| Ingredient: | teduglutide |
| Patents: | 2 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 203441
Generic Entry Date for 203441*:
Constraining patent/regulatory exclusivity:
TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH SHORT BOWEL SYNDROME (SBS) WHO ARE DEPENDENT ON PARENTERAL SUPPORT Dosage:
POWDER;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: 203441
| Ingredient-type | Analogs/Derivatives Glucagon-Like Peptide 2 |
| Mechanism of Action | Glucagon-like Peptide-2 (GLP-2) Agonists |
Suppliers and Packaging for NDA: 203441
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GATTEX KIT | teduglutide | POWDER;SUBCUTANEOUS | 203441 | NDA | Takeda Pharmaceuticals America, Inc. | 68875-0101 | 68875-0101-2 | 30 VIAL in 1 CARTON (68875-0101-2) / .5 mL in 1 VIAL (68875-0101-1) |
| GATTEX KIT | teduglutide | POWDER;SUBCUTANEOUS | 203441 | NDA | Takeda Pharmaceuticals America, Inc. | 68875-0102 | 68875-0102-1 | 1 KIT in 1 CARTON (68875-0102-1) * .5 mL in 1 SYRINGE, PLASTIC * .7 mL in 1 PACKET * .5 mL in 1 VIAL (68875-0101-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;SUBCUTANEOUS | Strength | 5MG/VIAL | ||||
| Approval Date: | Dec 21, 2012 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 16, 2026 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH SHORT BOWEL SYNDROME (SBS) WHO ARE DEPENDENT ON PARENTERAL SUPPORT | ||||||||
| Patent: | 7,847,061*PED | Patent Expiration: | May 1, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
| Patent: | 9,060,992*PED | Patent Expiration: | May 1, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y | ||
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