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Last Updated: December 15, 2025

Naldemedine tosylate - Generic Drug Details


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What are the generic sources for naldemedine tosylate and what is the scope of freedom to operate?

Naldemedine tosylate is the generic ingredient in one branded drug marketed by Bdsi and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Naldemedine tosylate has seventy-five patent family members in twenty-seven countries.

One supplier is listed for this compound.

Summary for naldemedine tosylate
International Patents:75
US Patents:5
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 3
DailyMed Link:naldemedine tosylate at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for naldemedine tosylate
Generic Entry Date for naldemedine tosylate*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*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.

Pharmacology for naldemedine tosylate
Drug ClassOpioid Antagonist
Mechanism of ActionOpioid Antagonists

US Patents and Regulatory Information for naldemedine tosylate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bdsi SYMPROIC naldemedine tosylate TABLET;ORAL 208854-001 Mar 23, 2017 RX Yes Yes RE46375 ⤷  Get Started Free Y Y ⤷  Get Started Free
Bdsi SYMPROIC naldemedine tosylate TABLET;ORAL 208854-001 Mar 23, 2017 RX Yes Yes 9,108,975 ⤷  Get Started Free Y Y ⤷  Get Started Free
Bdsi SYMPROIC naldemedine tosylate TABLET;ORAL 208854-001 Mar 23, 2017 RX Yes Yes 12,350,377 ⤷  Get Started Free Y ⤷  Get Started Free
Bdsi SYMPROIC naldemedine tosylate TABLET;ORAL 208854-001 Mar 23, 2017 RX Yes Yes RE46365 ⤷  Get Started Free Y Y ⤷  Get Started Free
Bdsi SYMPROIC naldemedine tosylate TABLET;ORAL 208854-001 Mar 23, 2017 RX Yes Yes 10,952,968 ⤷  Get Started Free Y Y ⤷  Get Started Free
>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 naldemedine tosylate

Country Patent Number Title Estimated Expiration
Mexico 2013005241 CRISTAL DE DERIVADO DE 6,7-INSATURADO-7-CARBAMOIL MORFINANO Y METODO PARA PRODUCIR EL MISMO. (CRYSTALLINE 6,7-UNSATURATED-7-CARBAMOYL MORPHINANE DERIVATIVE, AND METHOD FOR PRODUCING SAME.) ⤷  Get Started Free
South Korea 20130121119 ⤷  Get Started Free
World Intellectual Property Organization (WIPO) 2006126529 ⤷  Get Started Free
Japan WO2012063933 ⤷  Get Started Free
Denmark 2851075 ⤷  Get Started Free
Serbia 59256 KRISTALNI DERIVAT 6,7-NEZASIĆENOG-7-KARBAMOIL MORFINANA, I POSTUPAK NJEGOVE PROIZVODNJE (CRYSTALLINE 6,7-UNSATURATED-7-CARBAMOYL MORPHINANE DERIVATIVE, AND METHOD FOR PRODUCING SAME) ⤷  Get Started Free
World Intellectual Property Organization (WIPO) 2013172297 ⤷  Get Started Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for naldemedine tosylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1889848 SPC/GB19/050 United Kingdom ⤷  Get Started Free PRODUCT NAME: NALDEMEDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR THE TOSYLATE SALT; REGISTERED: UK EU/1/18/1291(FOR NI) 20190220; UK PLGB 50999/0003 20190220
1889848 19C1042 France ⤷  Get Started Free PRODUCT NAME: NALDEMEDINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES OU SOLVATES, EN PARTICULIER LE SEL DE TOSYLATE; REGISTRATION NO/DATE: EU/1/18/1291 20190220
1889848 CR 2019 00035 Denmark ⤷  Get Started Free PRODUCT NAME: NALDEMEDIN ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, SAERLIGT TOSYLAT SALTET; REG. NO/DATE: EU/1/18/1291 20190220
1889848 300996 Netherlands ⤷  Get Started Free PRODUCT NAME: NALDEMEDINE DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, IN HET BIJZONDER HET TOSYLAATZOUT; REGISTRATION NO/DATE: EU/1/18/1291 20190220
1889848 2019/038 Ireland ⤷  Get Started Free PRODUCT NAME: NALDEMEDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR THE TOSYLATE SALT.; REGISTRATION NO/DATE: EU/1/18/1291 20190218
1889848 763 Finland ⤷  Get Started Free
1889848 1990036-4 Sweden ⤷  Get Started Free PRODUCT NAME: NALDEMEDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEROF, IN PARTICULAR THE TOSYLATE SALT; REG. NO/DATE: EU/1/18/1291 20190220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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