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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 214846


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NDA 214846 describes MYFEMBREE, which is a drug marketed by Sumitomo Pharma 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 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.
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.

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:RXDosage:TABLET;ORALStrength1MG;0.5MG;40MG
Approval Date:May 26, 2021TE: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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.