Orserdu is a drug owned by Stemline Therapeutics Inc. It is protected by 8 US drug patents filed in 2023 out of which none have expired yet. Orserdu's patents will be open to challenges from 27 January, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 05, 2038. Details of Orserdu'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. | |||
| US10385008 | Polymorphic forms of RAD1901-2HCL |
Jan, 2038
(13 years from now) | Active |
| US7612114 | Selective estrogen receptor modulator |
Aug, 2026
(1 year, 7 months from now) | Active |
| US8399520 | Selective estrogen receptor modulator |
Dec, 2025
(1 year, 6 days from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10745343 | Polymorphic forms of RAD1901-2HCl |
Jan, 2038
(13 years from now) | Active |
| US11819480 | Methods for treating cancer |
Nov, 2036
(11 years from now) | Active |
| US11779552 | Method of treating cancer using selective estrogen receptor modulators |
Oct, 2034
(9 years from now) | Active |
| US10420734 | Method of treating cancer using selective estrogen receptor modulators |
Oct, 2034
(9 years from now) | Active |
| US10071066 | Method of treating cancer using selective estrogen receptor modulators |
Oct, 2034
(9 years from now) | Active |
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 Orserdu's patents.
Latest Legal Activities on Orserdu's Patents
Given below is the list of recent legal activities going on the following patents of Orserdu.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Email Notification Critical | 09 Apr, 2024 | US11819480 |
| Mail Pet Dec Routed to Certificate of Corrections Branch | 08 Apr, 2024 | US11819480 |
| Mail-Record a Petition Decision of Granted for Patent Term Adjustment after Issue | 08 Apr, 2024 | US11819480 |
| Pet Dec Routed to Certificate of Corrections Branch | 05 Apr, 2024 | US11819480 |
| Record a Petition Decision of Granted for Patent Term Adjustment after Issue | 05 Apr, 2024 | US11819480 |
| Adjustment of PTA Calculation by PTO | 05 Apr, 2024 | US11819480 |
| Second letter to regulating agency to determine regulatory review period | 08 Feb, 2024 | US10071066 |
| Second letter to regulating agency to determine regulatory review period | 08 Feb, 2024 | US7612114 |
| Second letter to regulating agency to determine regulatory review period | 08 Feb, 2024 | US10420734 |
| Second letter to regulating agency to determine regulatory review period | 08 Feb, 2024 | US8399520 |
FDA has granted several exclusivities to Orserdu. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Orserdu, 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 Orserdu.
Exclusivity Information
Orserdu holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Orserdu's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jan 27, 2028 |
US patents provide insights into the exclusivity only within the United States, but Orserdu 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 Orserdu's family patents as well as insights into ongoing legal events on those patents.
Orserdu's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Orserdu's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 05, 2038 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Orserdu Generics:
There are no approved generic versions for Orserdu as of now.
About Orserdu
Orserdu is a drug owned by Stemline Therapeutics Inc. It is used for the treatment of ER-positive breast cancer, especially in patients who have already undergone at least one line of endocrine therapy. Orserdu uses Elacestrant Dihydrochloride as an active ingredient. Orserdu was launched by Stemline Therap in 2023.
Approval Date:
Orserdu was approved by FDA for market use on 27 January, 2023.
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 Orserdu is 27 January, 2023, its NCE-1 date is estimated to be 27 January, 2027.
Active Ingredient:
Orserdu uses Elacestrant Dihydrochloride as the active ingredient. Check out other Drugs and Companies using Elacestrant Dihydrochloride ingredient
Treatment:
Orserdu is used for the treatment of ER-positive breast cancer, especially in patients who have already undergone at least one line of endocrine therapy.
Dosage:
Orserdu is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 86MG BASE | TABLET | Prescription | ORAL |
| EQ 345MG BASE | TABLET | Prescription | ORAL |