Details for New Drug Application (NDA): 217806
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NDA 217806 describes ZEPBOUND KWIKPEN, which is a drug marketed by Eli Lilly And Co and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the ZEPBOUND KWIKPEN profile page.
The generic ingredient in ZEPBOUND KWIKPEN is tirzepatide. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the tirzepatide profile page.
The generic ingredient in ZEPBOUND KWIKPEN is tirzepatide. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the tirzepatide profile page.
Summary for 217806
| Tradename: | ZEPBOUND KWIKPEN |
| Applicant: | Eli Lilly And Co |
| Ingredient: | tirzepatide |
| Patents: | 8 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217806
Generic Entry Date for 217806*:
Constraining patent/regulatory exclusivity:
TREATMENT OF MODERATE TO SEVERE OBSTRUCTIVE SLEEP APNEA (OSA) IN ADULTS WITH OBESITY 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: 217806
| Mechanism of Action | G-Protein-linked Receptor Interactions Glucagon-like Peptide-1 (GLP-1) Agonists |
Suppliers and Packaging for NDA: 217806
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ZEPBOUND | tirzepatide | SOLUTION;SUBCUTANEOUS | 217806 | NDA | Eli Lilly and Company | 0002-0152 | 0002-0152-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0002-0152-01) / .5 mL in 1 VIAL, SINGLE-DOSE |
| ZEPBOUND (AUTOINJECTOR) | tirzepatide | SOLUTION;SUBCUTANEOUS | 217806 | NDA | Eli Lilly and Company | 0002-0152 | 0002-0152-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0002-0152-01) / .5 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | 2.5MG/0.5ML (2.5MG/0.5ML) | ||||
| Approval Date: | Nov 8, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Oct 18, 2027 | ||||||||
| Regulatory Exclusivity Use: | LABELING REVISIONS RELATED TO CLINICAL STUDIES | ||||||||
| Regulatory Exclusivity Expiration: | May 13, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Nov 8, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
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