ORSERDU Drug Patent Profile
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When do Orserdu patents expire, and what generic alternatives are available?
Orserdu is a drug marketed by Stemline Therap and is included in one NDA. There are eight patents protecting this drug.
This drug has one hundred and sixteen patent family members in twenty-six countries.
The generic ingredient in ORSERDU is elacestrant dihydrochloride. One supplier is listed for this compound. Additional details are available on the elacestrant dihydrochloride profile page.
DrugPatentWatch® Generic Entry Outlook for Orserdu
Orserdu will be eligible for patent challenges on January 27, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be January 27, 2028. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Questions you can ask:
- What is the 5 year forecast for ORSERDU?
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Summary for ORSERDU
| International Patents: | 116 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 51 |
| Clinical Trials: | 1 |
| Patent Applications: | 109 |
| Drug Prices: | Drug price information for ORSERDU |
| What excipients (inactive ingredients) are in ORSERDU? | ORSERDU excipients list |
| DailyMed Link: | ORSERDU at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ORSERDU
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for ORSERDU
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Berlin-Chemie AG Menarini Group | Phase 1/Phase 2 |
| Carrick Therapeutics Limited | Phase 1/Phase 2 |
Pharmacology for ORSERDU
| Drug Class | Estrogen Receptor Antagonist |
| Mechanism of Action | Breast Cancer Resistance Protein Inhibitors Estrogen Receptor Antagonists P-Glycoprotein Inhibitors |
US Patents and Regulatory Information for ORSERDU
ORSERDU is protected by eight US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of ORSERDU is ⤷ Sign Up.
This potential generic entry date is based on NEW CHEMICAL ENTITY.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting ORSERDU
Method of treating cancer using selective estrogen receptor modulators
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF AN ER-POSITIVE BREAST CANCER FOLLOWING AT LEAST ONE LINE OF ENDOCRINE THERAPY
Polymorphic forms of RAD1901-2HCL
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Method of treating cancer using selective estrogen receptor modulators
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF AN ER-POSITIVE BREAST CANCER FOLLOWING AT LEAST ONE LINE OF ENDOCRINE THERAPY
Polymorphic forms of RAD1901-2HCl
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF AN ER-POSITIVE BREAST CANCER
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF AN ER-POSITIVE BREAST CANCER FOLLOWING AT LEAST ONE LINE OF ENDOCRINE THERAPY
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF AN ER-POSITIVE BREAST CANCER
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF AN ER-POSITIVE BREAST CANCER
Selective estrogen receptor modulator
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF AN ER-POSITIVE BREAST CANCER
FDA Regulatory Exclusivity protecting ORSERDU
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Stemline Therap | ORSERDU | elacestrant dihydrochloride | TABLET;ORAL | 217639-001 | Jan 27, 2023 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Stemline Therap | ORSERDU | elacestrant dihydrochloride | TABLET;ORAL | 217639-002 | Jan 27, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Stemline Therap | ORSERDU | elacestrant dihydrochloride | TABLET;ORAL | 217639-001 | Jan 27, 2023 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for ORSERDU
See the table below for patents covering ORSERDU around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Brazil | 112017023228 | métodos para tratamento de câncer | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2004058682 | ⤷ Sign Up | |
| Serbia | 65694 | POLIMORFNI OBLICI RAD1901-2HCL (POLYMORPHIC FORMS OF RAD1901-2HCL) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ORSERDU
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3122426 | 122024000013 | Germany | ⤷ Sign Up | PRODUCT NAME: ELACESTRANT ODER EIN SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1757 20230915 |
| 3122426 | 2024C/505 | Belgium | ⤷ Sign Up | PRODUCT NAME: ELACESTRANT OU UN SEL DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/23/1757 20230918 |
| 3122426 | 301263 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ELACESTRANT, DESGEWENST IN DE VORM VAN ELACESTRANTDIHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/23/1757 20230918 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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