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-four patent family members in twenty-seven countries.
One supplier is listed for this compound.
Summary for naldemedine tosylate
International Patents: | 74 |
US Patents: | 4 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 3 |
Patent Applications: | 143 |
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 Class | Opioid Antagonist |
Mechanism of Action | Opioid Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for naldemedine tosylate
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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Bdsi | SYMPROIC | naldemedine tosylate | TABLET;ORAL | 208854-001 | Mar 23, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Bdsi | SYMPROIC | naldemedine tosylate | TABLET;ORAL | 208854-001 | Mar 23, 2017 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
>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.) | ⤷ Try a Trial |
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) | ⤷ Try a Trial |
Russian Federation | 2643807 | КРИСТАЛЛЫ ПРОИЗВОДНЫХ 6,7-НЕНАСЫЩЕННОГО-7-КАРБАМОИЛМОРФИНАНА И СПОСОБ ИХ ПОЛУЧЕНИЯ (CRYSTALS OF 6,7-UNSATURATED-7-CARBAMOYLMORPHINANE DERIVATIVES AND METHOD OF THEIR PRODUCTION) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for naldemedine tosylate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1889848 | 1990036-4 | Sweden | ⤷ Try a 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 | SPC/GB19/050 | United Kingdom | ⤷ Try a Trial | 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 | ⤷ Try a Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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