Details for New Drug Application (NDA): 214846
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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: | Sumitomo Pharma |
Ingredient: | estradiol; norethindrone acetate; relugolix |
Patents: | 7 |
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 |
---|---|---|---|---|---|---|---|
Sumitomo Pharma | MYFEMBREE | estradiol; norethindrone acetate; relugolix | TABLET;ORAL | 214846-001 | May 26, 2021 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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