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Last Updated: June 25, 2021

DrugPatentWatch Database Preview

SYMPROIC Drug Profile


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When do Symproic patents expire, and what generic alternatives are available?

Symproic is a drug marketed by Bdsi and is included in one NDA. There are three patents protecting this drug.

This drug has sixty-three patent family members in twenty-five countries.

The generic ingredient in SYMPROIC is naldemedine tosylate. One supplier is listed for this compound. Additional details are available on the naldemedine tosylate profile page.

DrugPatentWatch® Generic Entry Outlook for Symproic

Symproic was eligible for patent challenges on March 23, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be November 11, 2031. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for SYMPROIC
International Patents:63
US Patents:3
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 9
Patent Applications: 59
Drug Prices: Drug price information for SYMPROIC
What excipients (inactive ingredients) are in SYMPROIC?SYMPROIC excipients list
DailyMed Link:SYMPROIC at DailyMed
Drug patent expirations by year for SYMPROIC
Drug Prices for SYMPROIC

See drug prices for SYMPROIC

DrugPatentWatch® Estimated Generic Entry Opportunity Date for SYMPROIC
Generic Entry Date for SYMPROIC*:
Constraining patent/regulatory exclusivity:
NDA:
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 SYMPROIC
Drug ClassOpioid Antagonist
Mechanism of ActionOpioid Antagonists

US Patents and Regulatory Information for SYMPROIC

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   Get Started Free   Get Started Free Y Y   Get Started Free
Bdsi SYMPROIC naldemedine tosylate TABLET;ORAL 208854-001 Mar 23, 2017 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Bdsi SYMPROIC naldemedine tosylate TABLET;ORAL 208854-001 Mar 23, 2017 RX Yes Yes   Get Started Free   Get Started Free Y Y   Get Started Free
Bdsi SYMPROIC naldemedine tosylate TABLET;ORAL 208854-001 Mar 23, 2017 RX Yes Yes   Get Started Free   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

Supplementary Protection Certificates for SYMPROIC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 C201930045 Spain   Get Started Free PRODUCT NAME: NADELMEDINA; NATIONAL AUTHORISATION NUMBER: EU/1/18/1291; DATE OF AUTHORISATION: 20190218; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1291; DATE OF FIRST AUTHORISATION IN EEA: 20190218
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
1889848 2019C/533 Belgium   Get Started Free 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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