Generic Myfembree Availability
Last updated on Apr 10, 2024.
Myfembree is a brand name of estradiol/norethindrone/relugolix, approved by the FDA in the following formulation(s):
MYFEMBREE (estradiol; norethindrone acetate; relugolix - tablet;oral)
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Manufacturer: MYOVANT SCIENCES
Approval date: May 26, 2021
Strength(s): 1MG;0.5MG;40MG [RLD]
Has a generic version of Myfembree been approved?
No. There is currently no therapeutically equivalent version of Myfembree available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Myfembree. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Methods of treating uterine fibroids
Patent 11,033,551
Issued: June 15, 2021
Inventor(s): Johnson Brendan Mark & Seely Lynn & Mudd & Jr. Paul N. & Wollowitz Susan & Hibberd Mark & Tanimoto Masataka & Rajasekhar Vijaykumar Reddy & Sukhatme Mayukh VasantMethods for treating uterine fibroids, endometriosis, adenomyosis, or heavy menstrual bleeding in a subject, which include administering to the subject from 10 mg to 60 mg per day of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-N′-methoxyurea, and from 0.01 mg to 5 mg per day of a hormone replacement medicament. The present disclosure has methods for reducing menstrual bleeding in a subject, reducing bone mineral density loss in a subject caused by administering a GnRH antagonist to the subject, suppressing sex hormones in a subject, reducing vasomotor symptoms or hot flashes in a subject, and reducing symptoms of decreased libido in a subject having uterine fibroids, endometriosis, or adenomyosis. Further provided are methods of maintaining blood glucose profile, maintaining lipid profile, and/or maintaining bone mineral density in a pre-menopausal woman being treated for one or more conditions or symptoms of endometriosis, adenomyosis, uterine fibroids, or heavy menstrual bleeding; and methods of contraception and treating infertility.
Patent expiration dates:
- September 29, 2037✓
- September 29, 2037
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Patent 11,793,812
Patent expiration dates:
- May 3, 2038✓
- May 3, 2038
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Patent 11,795,178
Patent expiration dates:
- September 27, 2033✓✓
- September 27, 2033
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Patent 7,300,935
Patent expiration dates:
- January 28, 2025✓
- January 28, 2025
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Patent 8,058,280
Patent expiration dates:
- January 28, 2025✓
- January 28, 2025
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Thienopyrimidine compounds and use thereof
Patent 9,346,822
Issued: May 24, 2016
Inventor(s): Cho Nobuo & Imada Takashi & Hitaka Takenori & Miwa Kazuhiro & Kusaka Masami & Suzuki Nobuhiro
Assignee(s): Takeda Pharmaceutical Company LimitedThe present invention provides a compound represented by the formula:
Patent expiration dates:
- February 17, 2024✓
- February 17, 2024
Related exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Exclusivity expiration dates:
- May 26, 2024 - NEW PRODUCT
- August 5, 2025 - FOR THE MANAGEMENT OF MODERATE TO SEVERE PAIN ASSOCIATED WITH ENDOMETRIOSIS
- December 18, 2025 - NEW CHEMICAL ENTITY
- January 27, 2026 - INFORMATION ADDED TO THE LABELING TO DESCRIBE THE RESULTS OF MVT-601-035
More about Myfembree (estradiol / norethindrone / relugolix)
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- During pregnancy
- FDA approval history
- Drug class: sex hormone combinations
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Glossary
Term | Definition |
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Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.