Osphena is a drug owned by Duchesnay Inc. It is protected by 8 US drug patents filed from 2013 to 2018. Out of these, 3 drug patents are active and 5 have expired. Osphena's patents have been open to challenges since 26 February, 2017. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 09, 2028. Details of Osphena's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8642079 | Solid formulations of ospemifene |
Jul, 2028
(3 years from now) | Active |
| US8236861 | Method for enhancing the bioavailablity of ospemifene |
Aug, 2026
(1 year, 8 months from now) | Active |
| US6245819 | Method for the treatment of vaginal dryness and sexual dysfunction in women during or after the menopause |
Jul, 2025
(8 months from now) | Active |
| US9241915 | Method for enhancing the bioavailability of ospemifene |
Feb, 2024
(9 months ago) |
Expired
|
| US9855224 | Method for enhancing the bioavailability of ospemifene |
Feb, 2024
(9 months ago) |
Expired
|
| US8772353 | Method for enhancing the bioavalability of ospemifene |
Feb, 2024
(9 months ago) |
Expired
|
| US8470890 | Method for enhancing the bioavailability of ospemifene |
Feb, 2024
(9 months ago) |
Expired
|
| US9566252 | Method for the alleviation of dyspareunia in women |
Nov, 2022
(2 years 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 Osphena's patents.
Latest Legal Activities on Osphena's Patents
Given below is the list of recent legal activities going on the following patents of Osphena.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 04 Mar, 2024 | US9241915 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 07 Feb, 2024 | US8236861 |
| Maintenance Fee Reminder Mailed Critical | 18 Sep, 2023 | US9241915 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 10 Jan, 2022 | US8772353 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 08 Jul, 2021 | US8642079 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 23 Jun, 2021 | US9855224 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Oct, 2020 | US8470890 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 08 Jul, 2020 | US9566252 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 Jan, 2020 | US8236861 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 14 Jun, 2019 | US9241915 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Osphena and ongoing litigations to help you estimate the early arrival of Osphena generic.
Osphena's Litigations
Osphena been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Aug 19, 2013, against patent number US9566252. The petitioner , challenged the validity of this patent, with Kaija Halonen et al as the respondent. Click below to track the latest information on how companies are challenging Osphena's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US9566252 | August, 2013 |
Decision
(06 Jul, 2016) | Kaija Halonen et al | |
FDA has granted some exclusivities to Osphena. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Osphena, 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 Osphena.
Exclusivity Information
Osphena holds 2 exclusivities. All of its exclusivities have expired in 2022. Details of Osphena's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Feb 26, 2018 |
| New Indication(I-793) | Jan 25, 2022 |
US patents provide insights into the exclusivity only within the United States, but Osphena 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 Osphena's family patents as well as insights into ongoing legal events on those patents.
Osphena's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Osphena's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 09, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Osphena Generic API suppliers:
Ospemifene is the generic name for the brand Osphena. 1 company has already filed for the generic of Osphena. Check out the entire list of companies who have already received approval for Osphena's generic
How can I launch a generic of Osphena before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Osphena's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Osphena's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Osphena -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 60 mg | 29 Dec, 2020 | 1 | 09 Jul, 2028 |
Alternative Brands for Osphena
Osphena which is used for treating symptoms of urogenital atrophy, dyspareunia, and vaginal dryness associated with menopause., 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 | ||
|---|---|---|---|---|
| Aspen |
| |||
About Osphena
Osphena is a drug owned by Duchesnay Inc. It is used for treating symptoms of urogenital atrophy, dyspareunia, and vaginal dryness associated with menopause. Osphena uses Ospemifene as an active ingredient. Osphena was launched by Duchesnay in 2013.
Approval Date:
Osphena was approved by FDA for market use on 26 February, 2013.
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 Osphena is 26 February, 2013, its NCE-1 date is estimated to be 26 February, 2017.
Active Ingredient:
Osphena uses Ospemifene as the active ingredient. Check out other Drugs and Companies using Ospemifene ingredient
Treatment:
Osphena is used for treating symptoms of urogenital atrophy, dyspareunia, and vaginal dryness associated with menopause.
Dosage:
Osphena is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 60MG | TABLET | Prescription | ORAL |