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Last Updated: May 26, 2022

Naldemedine tosylate - Generic Drug Details


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What are the generic drug sources for naldemedine tosylate and what is the scope of patent protection?

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

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

One supplier is listed for this compound.

Summary for naldemedine tosylate
International Patents:71
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 1
Patent Applications: 144
DailyMed Link:naldemedine tosylate at DailyMed
Pharmacology for naldemedine tosylate
Drug ClassOpioid Antagonist
Mechanism of Action Opioid 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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Bdsi SYMPROIC naldemedine tosylate TABLET;ORAL 208854-001 Mar 23, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bdsi SYMPROIC naldemedine tosylate TABLET;ORAL 208854-001 Mar 23, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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
European Patent Office 2639234 DÉRIVÉ 6,7-INSATURATÉ-7-CARBAMOYL-MORPHINANE ET PROCÉDÉ POUR LE PRODUIRE (CRYSTALLINE 6,7-UNSATURATED-7-CARBAMOYL MORPHINANE DERIVATIVE, AND METHOD FOR PRODUCING SAME) See Plans and Pricing
Denmark 2639234 See Plans and Pricing
European Patent Office 2851075 PRÉPARATION CONTENANT UN DÉRIVÉ DE 7-CARBAMOYLMORPHINANE 6,7-INSATURÉ (PREPARATION CONTAINING 6,7-UNSATURATED-7-CARBAMOYLMORPHINAN DERIVATIVE) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for naldemedine tosylate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1889848 CA 2019 00035 Denmark See Plans and Pricing PRODUCT NAME: NALDEMEDIN ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, SAERLIGT TOSYLAT SALTET; REG. NO/DATE: EU/1/18/1291 20190220
1889848 19C1042 France See Plans and Pricing 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 38/2019 Austria See Plans and Pricing PRODUCT NAME: NALDEMEDINE ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON, INSBESONDERE DAS TOSYLATSALZ; REGISTRATION NO/DATE: EU/1/18/1291 (MITTEILUNG) 20190220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
AstraZeneca
Moodys
Mallinckrodt
Johnson and Johnson
McKesson

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