Details for New Drug Application (NDA): 214846
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NDA 214846 describes MYFEMBREE, which is a drug marketed by Myovant Sciences and is included in one NDA. It is available from one supplier. There are six patents protecting this drug. Additional details are available on the MYFEMBREE profile page.
The generic ingredient in MYFEMBREE is estradiol; norethindrone acetate; relugolix. There are seventy-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the estradiol; norethindrone acetate; relugolix profile page.
The generic ingredient in MYFEMBREE is estradiol; norethindrone acetate; relugolix. There are seventy-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the estradiol; norethindrone acetate; relugolix profile page.
Summary for 214846
| Tradename: | MYFEMBREE |
| Applicant: | Myovant Sciences |
| Ingredient: | estradiol; norethindrone acetate; relugolix |
| Patents: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214846
Generic Entry Date for 214846*:
Constraining patent/regulatory exclusivity:
INFORMATION ADDED TO THE LABELING TO DESCRIBE THE RESULTS OF MVT-601-035 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: 214846
Suppliers and Packaging for NDA: 214846
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MYFEMBREE | estradiol; norethindrone acetate; relugolix | TABLET;ORAL | 214846 | NDA | Sumitomo Pharma America, Inc | 72974-415 | 72974-415-01 | 28 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-415-01) |
| MYFEMBREE | estradiol; norethindrone acetate; relugolix | TABLET;ORAL | 214846 | NDA | Sumitomo Pharma America, Inc | 72974-415 | 72974-415-99 | 7 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72974-415-99) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG;0.5MG;40MG | ||||
| Approval Date: | May 26, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Aug 5, 2025 | ||||||||
| Regulatory Exclusivity Use: | FOR THE MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS | ||||||||
| Regulatory Exclusivity Expiration: | Jan 27, 2026 | ||||||||
| Regulatory Exclusivity Use: | INFORMATION ADDED TO THE LABELING TO DESCRIBE THE RESULTS OF MVT-601-035 | ||||||||
| Regulatory Exclusivity Expiration: | Dec 18, 2025 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
Expired US Patents for NDA 214846
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Myovant Sciences | MYFEMBREE | estradiol; norethindrone acetate; relugolix | TABLET;ORAL | 214846-001 | May 26, 2021 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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