Details for New Drug Application (NDA): 215866
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NDA 215866 describes MOUNJARO KWIKPEN, which is a drug marketed by Eli Lilly And Co and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug. Additional details are available on the MOUNJARO KWIKPEN profile page.
The generic ingredient in MOUNJARO 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 MOUNJARO 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 215866
| Tradename: | MOUNJARO KWIKPEN |
| Applicant: | Eli Lilly And Co |
| Ingredient: | tirzepatide |
| Patents: | 8 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215866
Generic Entry Date for 215866*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION 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: 215866
| Mechanism of Action | G-Protein-linked Receptor Interactions Glucagon-like Peptide-1 (GLP-1) Agonists |
Suppliers and Packaging for NDA: 215866
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MOUNJARO | tirzepatide | SOLUTION;SUBCUTANEOUS | 215866 | NDA | Eli Lilly and Company | 0002-1152 | 0002-1152-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0002-1152-01) / .5 mL in 1 VIAL, SINGLE-DOSE |
| MOUNJARO (AUTOINJECTOR) | tirzepatide | SOLUTION;SUBCUTANEOUS | 215866 | NDA | Eli Lilly and Company | 0002-1152 | 0002-1152-01 | 1 VIAL, SINGLE-DOSE in 1 CARTON (0002-1152-01) / .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: | May 13, 2022 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 13, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Dec 19, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Patent: | 11,357,820 | Patent Expiration: | Jun 14, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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