Myfembree is a drug owned by Sumitomo Pharma Switzerland Gmbh. It is protected by 7 US drug patents filed from 2021 to 2024. Out of these, 6 drug patents are active and 1 has expired. Myfembree's patents have been open to challenges since 18 December, 2024. Based on its patents and exclusivities, its generic launch date is estimated to be May 03, 2038. Details of Myfembree's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US11795178 | Compositions of thienopyrimidine derivatives |
Sep, 2033
(8 years from now) | Active |
| US7300935 | Thienopyrimidine compounds and use thereof |
Jan, 2026
(8 months from now) | Active |
| US8058280 | Substituted thieno[2,3-d]pyrimidin-2,4-dione compounds and uses thereof |
Jan, 2026
(8 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11793812 | Methods of treating endometriosis |
May, 2038
(12 years from now) | Active |
| US11033551 | Methods of treating uterine fibroids |
Sep, 2037
(12 years from now) | Active |
| US11957684 | Treatment of heavy menstrual bleeding associated with uterine fibroids |
Sep, 2037
(12 years from now) | Active |
| US9346822 | Thienopyrimidine compounds and use thereof |
Feb, 2024
(1 year, 2 months ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Myfembree's patents.
Latest Legal Activities on Myfembree's Patents
Given below is the list of recent legal activities going on the following patents of Myfembree.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Email Notification Critical | 17 Apr, 2024 | US11957684 |
| Patent Issue Date Used in PTA Calculation Critical | 16 Apr, 2024 | US11957684 |
| Patent eGrant Notification | 16 Apr, 2024 | US11957684 |
| Recordation of Patent eGrant | 16 Apr, 2024 | US11957684 |
| Recordation of Patent Grant Mailed Critical | 16 Apr, 2024 | US11957684 |
| Mail Patent eGrant Notification | 16 Apr, 2024 | US11957684 |
| Email Notification Critical | 28 Mar, 2024 | US11957684 |
| Issue Notification Mailed Critical | 27 Mar, 2024 | US11957684 |
| Email Notification Critical | 14 Mar, 2024 | US11957684 |
| Mailing Corrected Notice of Allowability | 14 Mar, 2024 | US11957684 |
FDA has granted several exclusivities to Myfembree. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Myfembree, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Myfembree.
Exclusivity Information
Myfembree holds 4 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Myfembree's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | May 26, 2024 |
| New Indication(I-898) | Aug 05, 2025 |
| New Chemical Entity Exclusivity(NCE) | Dec 18, 2025 |
| M(M-289) | Jan 27, 2026 |
Several oppositions have been filed on Myfembree's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Myfembree's generic, the next section provides detailed information on ongoing and past EP oppositions related to Myfembree patents.
Myfembree's Oppositions Filed in EPO
Myfembree has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Dec 15, 2022, by Sandoz Ag. This opposition was filed on patent number EP17823018A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP17823018A | Dec, 2022 | SANDOZ AG | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Myfembree is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Myfembree's family patents as well as insights into ongoing legal events on those patents.
Myfembree's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Myfembree's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 03, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Myfembree Generics:
There are no approved generic versions for Myfembree as of now.
Alternative Brands for Myfembree
Myfembree which is used for managing heavy menstrual bleeding and pain associated with uterine fibroids in premenopausal women, as well as pain associated with endometriosis., has several other brand drugs in the same treatment category . Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Abbvie |
| |||
About Myfembree
Myfembree is a drug owned by Sumitomo Pharma Switzerland Gmbh. It is used for managing heavy menstrual bleeding and pain associated with uterine fibroids in premenopausal women, as well as pain associated with endometriosis. Myfembree uses Estradiol; Norethindrone Acetate; Relugolix as an active ingredient. Myfembree was launched by Sumitomo Pharma in 2021.
Approval Date:
Myfembree was approved by FDA for market use on 26 May, 2021.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Myfembree is 26 May, 2021, its NCE-1 date is estimated to be 18 December, 2024.
Active Ingredient:
Myfembree uses Estradiol; Norethindrone Acetate; Relugolix as the active ingredient. Check out other Drugs and Companies using Estradiol; Norethindrone Acetate; Relugolix ingredient
Treatment:
Myfembree is used for managing heavy menstrual bleeding and pain associated with uterine fibroids in premenopausal women, as well as pain associated with endometriosis.
Dosage:
Myfembree is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1MG;0.5MG;40MG | TABLET | Prescription | ORAL |