Generic Myfembree Availability
Last updated on Apr 10, 2025.
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: SUMITOMO PHARMA
Approval date: May 26, 2021
Strength(s): 1MG;0.5MG;40MG [RLD]
Is there a generic version of Myfembree available?
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 et al.
Assignee(s): Myovant Sciences GmbH (Basel, CH); Takeda Pharmaceutical Company Limited (Osaka, JP)Methods 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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Methods of treating endometriosis
Patent 11,793,812
Issued: October 24, 2023
Inventor(s): Johnson; Brendan Mark et al.
Assignee(s): Sumitomo Pharma Switzerland GmbH (Basel, CH); Takeda Pharmaceutical Company Limited (Osaka, JP)Methods 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:
- May 3, 2038✓
- May 3, 2038
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Compositions of thienopyrimidine derivatives
Patent 11,795,178
Issued: October 24, 2023
Inventor(s): Fukuoka; Koichiro et al.
Assignee(s): Takeda Pharmaceutical Company Limited (Osaka, JP)The present invention provides a production method of a thienopyrimidine derivative or a salt thereof which has a gonadotropin releasing hormone (GnRH) antagonistic action with high quality in high yield. The present invention provides a method of producing a thienopyrirnidine derivative, which comprises reacting 6-(4-aminophenyl)-1-(2,6-difluorobenzyl)-5-dimethylaminomethyl-3-(6-methoxypyridazin-3-yl)thieno[2,3-d]pyrimidine-2,4(1H,3H)-dione or salt thereof, 1,1′-carbonyldiimidazole or a salt thereof and methoxyamine or a salt thereof, and the like.
Patent expiration dates:
- September 27, 2033✓✓
- September 27, 2033
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Treatment of heavy menstrual bleeding associated with uterine fibroids
Patent 11,957,684
Issued: April 16, 2024
Inventor(s): Johnson; Brendan Mark et al.
Assignee(s): Sumitomo Pharma Switzerland GmbH (Basel, CH); Takeda Pharmaceutical Company Limited (Osaka, JP)Methods 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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Thienopyrimidine compounds and use thereof
Patent 7,300,935
Issued: November 27, 2007
Inventor(s): Cho; Nobuo et al.
Assignee(s): Takeda Pharmaceutical Company (Osaka, JP)The present invention provides a compound represented by the formula: ##STR00001## wherein R.sup.1 is a C.sub.1-4alkyl; R.sup.2 is (1) a 5- to 7-membered nitrogen-containing heterocyclic group which may have a substituent selected from the group consisting of (1') a halogen, (2') a hydroxy group, (3') a C.sub.1-4alkyl and (4') a C.sub.1-4alkoxy, (2) a phenyl which may have a substituent selected from the group consisting of (1') a halogen, (2') a C.sub.1-4alkoxy-C.sub.1-4alkyl, (3') a mono-C.sub.1-4alkyl-carbamoyl-C.sub.1-4alkyl, (4') a C.sub.1-4alkoxy and (5') a mono-C.sub.1-4alkylcarbamoyl-C.sub.1-4alkoxy, or the like; R.sup.3 is a C.sub.1-4alkyl; R.sup.4 is a C.sub.1-4alkoxy, or the like; n is an integer of 1 to 4; or a salt thereof, as a thienopyrimidine compound having gonadotropin-releasing hormone antagonistic activity.
Patent expiration dates:
- January 28, 2026✓
- January 28, 2026
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Substituted thieno[2,3-d]pyrimidin-2,4-dione compounds and uses thereof
Patent 8,058,280
Issued: November 15, 2011
Inventor(s): Cho; Nobuo et al.
Assignee(s): Takeda Pharmaceutical Company Limited (Fujisawa-Shi, JP)The present invention provides a compound represented by the formula: ##STR00001## wherein R.sup.1 is a C.sub.1-4 alkyl; R.sup.2 is (1) a 5- to 7-membered nitrogen-containing heterocyclic group which may have a substituent selected from the group consisting of (1') a halogen, (2') a hydroxy group, (3') a C.sub.1-4 alkyl and (4') a C.sub.1-4 alkoxy, (2) a phenyl which may have a substituent selected from the group consisting of (1') a halogen, (2') a C.sub.1-4 alkoxy-C.sub.1-4 alkyl, (3') a mono-C.sub.1-4 alkyl-carbamoyl-C.sub.1-4 alkyl, (4') a C.sub.1-4 alkoxy and (5') a mono-C.sub.1-4 alkylcarbamoyl-C.sub.1-4 alkoxy, or the like; R.sup.3 is a C.sub.1-4 alkyl; R.sup.4 is a C.sub.1-4 alkoxy, or the like; n is an integer of 1 to 4; or a salt thereof, as a thienopyrimidine compound having gonadotropin-releasing hormone antagonistic activity.
Patent expiration dates:
- January 28, 2026✓✓
- January 28, 2026
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:
- 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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Glossary
| Term | Definition |
|---|---|
| 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
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