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Last Updated: July 6, 2020

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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 three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Naldemedine tosylate has sixty-two patent family members in twenty-four countries.

Three suppliers are listed for this compound.

Summary for naldemedine tosylate
International Patents:62
US Patents:3
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: 3
Bulk Api Vendors: 1
Patent Applications: 1
DailyMed Link:naldemedine tosylate at DailyMed
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   Start Trial   Start Trial   Start Trial
Bdsi SYMPROIC naldemedine tosylate TABLET;ORAL 208854-001 Mar 23, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Bdsi SYMPROIC naldemedine tosylate TABLET;ORAL 208854-001 Mar 23, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Bdsi SYMPROIC naldemedine tosylate TABLET;ORAL 208854-001 Mar 23, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for naldemedine tosylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1889848 CA 2019 00035 Denmark   Start Trial PRODUCT NAME: NALDEMEDIN ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, SAERLIGT TOSYLAT SALTET; REG. NO/DATE: EU/1/18/1291 20190220
1889848 1990036-4 Sweden   Start Trial PRODUCT NAME: NALDEMEDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEROF, IN PARTICULAR THE TOSYLATE SALT; REG. NO/DATE: EU/1/18/1291 20190220
1889848 2019/038 Ireland   Start Trial 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 38/2019 Austria   Start Trial PRODUCT NAME: NALDEMEDINE ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON, INSBESONDERE DAS TOSYLATSALZ; REGISTRATION NO/DATE: EU/1/18/1291 (MITTEILUNG) 20190220
1889848 2019C/533 Belgium   Start Trial PRODUCT NAME: NALMEDINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT HIERVAN, IN BIJZONDER HET TOSYLAATZOUT; AUTHORISATION NUMBER AND DATE: EU/1/18/1291 20190220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Moodys
Medtronic
Boehringer Ingelheim
Express Scripts
McKesson

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