Details for New Drug Application (NDA): 219835
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NDA 219835 describes VEPPANU, which is a drug marketed by Rigel Pharms and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug. Additional details are available on the VEPPANU profile page.
The generic ingredient in VEPPANU is vepdegestrant. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the vepdegestrant profile page.
The generic ingredient in VEPPANU is vepdegestrant. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the vepdegestrant profile page.
Summary for 219835
| Tradename: | VEPPANU |
| Applicant: | Rigel Pharms |
| Ingredient: | vepdegestrant |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219835
Generic Entry Date for 219835*:
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.
Suppliers and Packaging for NDA: 219835
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VEPPANU | vepdegestrant | TABLET;ORAL | 219835 | NDA | Rigel Pharmaceuticals, Inc. | 71332-007 | 71332-007-30 | 30 TABLET, FILM COATED in 1 BOTTLE (71332-007-30) |
| VEPPANU | vepdegestrant | TABLET;ORAL | 219835 | NDA | Rigel Pharmaceuticals, Inc. | 71332-008 | 71332-008-30 | 30 TABLET, FILM COATED in 1 BOTTLE (71332-008-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 100MG | ||||
| Approval Date: | May 1, 2026 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | May 1, 2031 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jan 30, 2038 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Start Trial | Patent Expiration: | Dec 1, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF ADULTS WITH ER-POSITIVE, HER2-NEGATIVE ESR1-MUTATED ADVANCED OR METASTATIC BREAST CANCER WITH DISEASE PROGRESSION FOLLOWING AT LEAST ONE LINE OF ENDOCRINE THERAPY | ||||||||
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