Details for New Drug Application (NDA): 215866
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NDA 215866 describes MOUNJARO (AUTOINJECTOR), 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 MOUNJARO (AUTOINJECTOR) profile page.
The generic ingredient in MOUNJARO (AUTOINJECTOR) is tirzepatide. One supplier is listed for this compound. Additional details are available on the tirzepatide profile page.
The generic ingredient in MOUNJARO (AUTOINJECTOR) is tirzepatide. One supplier is listed for this compound. Additional details are available on the tirzepatide profile page.
Summary for 215866
| Tradename: | MOUNJARO (AUTOINJECTOR) |
| Applicant: | Eli Lilly And Co |
| Ingredient: | tirzepatide |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215866
Generic Entry Date for 215866*:
Constraining patent/regulatory exclusivity:
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 | ||||||||
| Patent: | 11,357,820 | Patent Expiration: | Jun 14, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | 12,295,987 | Patent Expiration: | Dec 30, 2041 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF TYPE 2 DIABETES BY ADMINISTERING IN 4 DOSES, AT LEAST 2 WEEKS APART, A GIP:GLP-1 PEPTIDE HAVING A GIP:GLP-1 RECEPTOR AGONIST POTENCY RATIO IN A RANGE DETERMINED BY A CASEIN CAMP ASSAY, WHERE DOSES ARE 25%, 50% AND 75% OF 4TH DOSE | ||||||||
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