Details for New Drug Application (NDA): 220934
NDA 220934 describes FOUNDAYO, which is a drug marketed by Eli Lilly And Co 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 FOUNDAYO profile page.
The generic ingredient in FOUNDAYO is orforglipron calcium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the orforglipron calcium profile page.
The generic ingredient in FOUNDAYO is orforglipron calcium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the orforglipron calcium profile page.
Summary for 220934
| Tradename: | FOUNDAYO |
| Applicant: | Eli Lilly And Co |
| Ingredient: | orforglipron calcium |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 220934
Generic Entry Date for 220934*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
TABLET;ORAL |
*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: 220934
| Mechanism of Action | Glucagon-like Peptide-1 (GLP-1) Agonists |
| Physiological Effect | Decreased Gastric Motility Increased Gastric Muscle Tone |
Suppliers and Packaging for NDA: 220934
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FOUNDAYO | orforglipron calcium | TABLET;ORAL | 220934 | NDA | Eli Lilly and Company | 0002-4178 | 0002-4178-31 | 1 BOTTLE in 1 CARTON (0002-4178-31) / 30 TABLET, FILM COATED in 1 BOTTLE (0002-4178-01) |
| FOUNDAYO | orforglipron calcium | TABLET;ORAL | 220934 | NDA | Eli Lilly and Company | 0002-4178 | 0002-4178-62 | 1 BOTTLE in 1 CARTON (0002-4178-62) / 30 TABLET, FILM COATED in 1 BOTTLE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 0.8MG BASE | ||||
| Approval Date: | Apr 1, 2026 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 1, 2031 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | RE50455 | Patent Expiration: | Sep 26, 2037 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | TREATMENT TO REDUCE EXCESS BODY WEIGHT AND MAINTAIN WEIGHT REDUCTION LONG TERM IN ADULTS WITH OBESITY OR OVERWEIGHT WITH AT LEAST ONE WEIGHT-RELATED COMORBID CONDITION BY ADMINISTERING AN EFFECTIVE AMOUNT OF ORFORGLIPRON | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE | ||||
| Approval Date: | Apr 1, 2026 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Apr 1, 2031 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
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