Details for New Drug Application (NDA): 217639
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NDA 217639 describes ORSERDU, which is a drug marketed by Stemline Therap and is included in one NDA. It is available from one supplier. There are seven patents protecting this drug. Additional details are available on the ORSERDU profile page.
The generic ingredient in ORSERDU is elacestrant hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the elacestrant hydrochloride profile page.
The generic ingredient in ORSERDU is elacestrant hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the elacestrant hydrochloride profile page.
Summary for 217639
| Tradename: | ORSERDU |
| Applicant: | Stemline Therap |
| Ingredient: | elacestrant hydrochloride |
| Patents: | 7 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 217639
Generic Entry Date for 217639*:
Constraining patent/regulatory exclusivity:
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: 217639
Suppliers and Packaging for NDA: 217639
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ORSERDU | elacestrant hydrochloride | TABLET;ORAL | 217639 | NDA | Stemline Therapeutics, Inc. | 72187-0101 | 72187-0101-3 | 30 TABLET, FILM COATED in 1 BOTTLE (72187-0101-3) |
| ORSERDU | elacestrant hydrochloride | TABLET;ORAL | 217639 | NDA | Stemline Therapeutics, Inc. | 72187-0102 | 72187-0102-3 | 30 TABLET, FILM COATED in 1 BOTTLE (72187-0102-3) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 86MG BASE | ||||
| Approval Date: | Jan 27, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Jan 27, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Oct 10, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | TREATMENT OF AN ER-POSITIVE BREAST CANCER FOLLOWING AT LEAST ONE LINE OF ENDOCRINE THERAPY | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Jan 5, 2038 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
Expired US Patents for NDA 217639
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Stemline Therap | ORSERDU | elacestrant hydrochloride | TABLET;ORAL | 217639-001 | Jan 27, 2023 | ⤷ Start Trial | ⤷ Start Trial |
| Stemline Therap | ORSERDU | elacestrant hydrochloride | TABLET;ORAL | 217639-002 | Jan 27, 2023 | ⤷ Start Trial | ⤷ Start Trial |
| Stemline Therap | ORSERDU | elacestrant hydrochloride | TABLET;ORAL | 217639-002 | Jan 27, 2023 | ⤷ Start Trial | ⤷ Start Trial |
| Stemline Therap | ORSERDU | elacestrant hydrochloride | TABLET;ORAL | 217639-001 | Jan 27, 2023 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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