Generic Orserdu Availability
Last updated on Apr 10, 2025.
Orserdu is a brand name of elacestrant, approved by the FDA in the following formulation(s):
ORSERDU (elacestrant hydrochloride - tablet;oral)
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Manufacturer: STEMLINE THERAP
Approval date: January 27, 2023
Strength(s): EQ 86MG BASE [RLD], EQ 345MG BASE [RLD]
Is there a generic version of Orserdu available?
No. There is currently no therapeutically equivalent version of Orserdu available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Orserdu. 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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Method of treating cancer using selective estrogen receptor modulators
Patent 10,071,066
Issued: September 11, 2018
Inventor(s): Wardell Suzanne E. & Nelson Erik R. & McDonnell Donald P.
Assignee(s): Duke UniversityDisclosed herein are methods of treating subjects suffering from estrogen receptor positive cancer of the brain by administering a selective estrogen receptor degrader (SERM). Also disclosed are methods of treating a cancer that is resistant to an estrogen receptor modulator by administering a SERM.
Patent expiration dates:
- October 10, 2034✓
- October 10, 2034
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Polymorphic forms of RAD1901-2HCL
Patent 10,385,008
Issued: August 20, 2019
Inventor(s): Cruskie & Jr. Michael Paul & Bolger Joshua Kyle & McKenzie Jonathan Blake & Sheth Pratik & Edwards Richard & Eberlin Alex & Markey Michael
Assignee(s): Radius Pharmaceuticals, Inc.Various polymorphic forms of RAD1901-2HCl, including three crystalline and amorphous forms, are prepared and characterized. Uses of the various polymorphic forms of RAD1901-2HCl for cancer treatment are also disclosed.
Patent expiration dates:
- January 5, 2038✓✓
- January 5, 2038
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Method of treating cancer using selective estrogen receptor modulators
Patent 10,420,734
Issued: September 24, 2019
Inventor(s): Wardell Suzanne E. & Nelson Erik R. & McDonnell Donald P.
Assignee(s): Duke UniversityDisclosed herein are methods of treating subjects suffering from estrogen receptor positive cancer of the brain by administering a selective estrogen receptor degrader (SERM). Also disclosed are methods of treating a cancer that is resistant to an estrogen receptor modulator by administering a SERM.
Patent expiration dates:
- October 10, 2034✓
- October 10, 2034
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Polymorphic forms of RAD1901-2HCl
Patent 10,745,343
Issued: August 18, 2020
Inventor(s): Cruskie & Jr. Michael Paul & Bolger Joshua Kyle & McKenzie Jonathan Blake & Sheth Pratik & Edwards Richard & Eberlin Alex & Markey Michael
Assignee(s): RADIUS PHARMACEUTICALS, INC.Various polymorphic forms of RAD1901-2HCl, including three crystalline and amorphous forms, are prepared and characterized. Uses of the various polymorphic forms of RAD1901-2HCl for cancer treatment are also disclosed.
Patent expiration dates:
- January 5, 2038✓
- January 5, 2038
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Method of treating cancer using selective estrogen receptor modulators
Patent 11,779,552
Issued: October 10, 2023
Inventor(s): Wardell; Suzanne E. et al.
Assignee(s): Duke University (Durham, NC)Disclosed herein are methods of treating subjects suffering from estrogen receptor positive cancer of the brain by administering a selective estrogen receptor degrader (SERM). Also disclosed are methods of treating a cancer that is resistant to an estrogen receptor modulator by administering a SERM.
Patent expiration dates:
- October 10, 2034✓
- October 10, 2034
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Methods for treating cancer
Patent 11,819,480
Issued: November 21, 2023
Inventor(s): Garner; Fiona et al.
Assignee(s): RADIUS PHARMACEUTICALS, INC. (Boston, MA)Disclosed herein are methods of inhibiting tumor growth or producing tumor regression in a subject having a drug-resistant estrogen receptor alpha positive cancer or a mutant estrogen receptor alpha positive cancer. The methods entail administering to the subject a therapeutically effective amount of RAD1901 having the structure: ##STR00001##
or a salt or solvate thereof.Patent expiration dates:
- November 29, 2036✓
- November 29, 2036
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Selective estrogen receptor modulator
Patent 7,612,114
Issued: November 3, 2009
Inventor(s): Hamaoka; Shinichi et al.
Assignee(s): Eisai R&D Management Co., Ltd. (Tokyo, JP)The present invention provides a compound represented by the following formula (I); ##STR00001## [wherein T represents a single bond, a C1-C4 alkylene group which may have a substituent and the like; formula (I-1) represents a single bond or a double bond; A represents a single bond, a bivalent 5- to 14-membered heterocyclic group which may have a substituent and the like; Y represents a single bond and the like; Z represents a methylene group and the like; ring G represents a phenylene group and the like which may condense with a 5- to 6-membered ring and may have a heteroatom; R.sup.a and R.sup.b are the same as or different from each other and represent a hydrogen atom and the like; W represents a single bond and the like; R' represents 1 to 4 independent hydrogen atoms and the like; and R'' represents 1 to 4 independent hydrogen atoms and the like] or a salt thereof, or a hydrate thereof.
Patent expiration dates:
- August 18, 2026✓✓✓
- August 18, 2026
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Selective estrogen receptor modulator
Patent 8,399,520
Issued: March 19, 2013
Inventor(s): Hamaoka Shinichi & Kitazawa Noritaka & Nara Kazumasa & Sasaki Atsushi & Kamada Atsushi & Okabe Tadashi
Assignee(s): Eisai R&D Management Co., Ltd.The present invention provides a compound represented by the following formula (I);
Patent expiration dates:
- December 25, 2025✓✓✓
- December 25, 2025
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:
- January 27, 2028 - NEW CHEMICAL ENTITY
More about Orserdu (elacestrant)
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- Drug class: estrogen receptor antagonists
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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
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
