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Last Updated: October 18, 2019

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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 fifty-two patent family members in nineteen countries.

Three suppliers are listed for this compound.

Summary for naldemedine tosylate
International Patents:52
US Patents:3
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: 3
Bulk Api Vendors: 1
DailyMed Link:naldemedine tosylate at DailyMed
Pharmacology for naldemedine tosylate
Drug ClassOpioid Antagonist
Mechanism of ActionOpioid Antagonists
Synonyms for naldemedine tosylate
1345728-04-2
17-(Cyclopropylmethyl)-6,7-didehydro-4,5a-epoxy-3,6,14-trihydroxy-N-(2-(3-phenyl-1,2,4-oxadiazol-5-yl)propan-2-yl)morphinan-7-carboxamide 4-methylbenzenesulfonic acid
CHEMBL3039508
D10478
DTXSID10158809
Morphinan-7-carboxamide, 17-(cyclopropylmethyl)-6,7-didehydro-4,5-epoxy-3,6,14-trihydroxy-N-(1-methyl-1-(3-phenyl-1,2,4-oxadiazol-5-yl)ethyl)-,(5alpha)-, 4-methylbenzenesulfonate (1:1)
Naldemedine tosylate (JAN/USAN)
Naldemedine tosylate [USAN]
SCHEMBL20720003
Symproic
UNII-V1N8F1RVVO
V1N8F1RVVO

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 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   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 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
1889848 122019000063 Germany   Start Trial PRODUCT NAME: NALDEMEDINE ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, INSBESONDERE DAS TOSYLAT SALZ; REGISTRATION NO/DATE: EU/1/18/1291 20190218
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 300996 Netherlands   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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