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Last Updated: February 29, 2024

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SYMPROIC Drug Patent 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 four patents protecting this drug.

This drug has seventy-four patent family members in twenty-seven 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 May 13, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for SYMPROIC
International Patents:74
US Patents:4
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 3
Patent Applications: 86
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 Loss of Exclusivity (LOE) 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

SYMPROIC is protected by four US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of SYMPROIC is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting SYMPROIC

Preparation containing 6,7-unsaturated-7-carbamoyl morphinan derivatives
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Crystal of 6,7-unsaturated-7-carbamoyl morphinan derivative and method for producing the same
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

6,7-unsaturated-7-carbamoyl substituted morphinan derivative
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

6,7-unsaturated-7-carbamoyl substituted morphinan derivative
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF OPIOID-INDUCED CONSTIPATION

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
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 SYMPROIC

When does loss-of-exclusivity occur for SYMPROIC?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Canada

Patent: 73961
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 51075
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 51075
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 2013172297
Estimated Expiration: ⤷  Try a Trial

Patent: 18219
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 51075
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 03149
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 1350120
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering SYMPROIC around the world.

Country Patent Number Title Estimated Expiration
Canada 2609733 DERIVE DE MORPHINANE SUBSTITUE PAR UN CARBAMOYLE EN POSITION7 ET AYANT UNE INSAURATION EN POSITION 6,7 (6,7-UNSATURATED-7-CARBAMOYL SUBSTITUTED MORPHINAN DERIVATIVE) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2012063933 ⤷  Try a Trial
France 19C1042 ⤷  Try a Trial
Japan WO2006126637 6,7−不飽和−7−カルバモイル置換モルヒナン誘導体 ⤷  Try a Trial
South Korea 101500915 ⤷  Try a Trial
Brazil PI0610343 composto derivado de morfinan substituìdo por 7-carbamoìla 6,7-insaturada, composição farmacêutica e uso do mesmo ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SYMPROIC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1889848 C201930045 Spain ⤷  Try a Trial 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 132019000000093 Italy ⤷  Try a Trial PRODUCT NAME: NALDEMEDINA O UN SUO SALE O SOLVATO FARMACEUTICAMENTE ACCETTABILE, IN PARTICOLARE IL SALE TOSILATO(RIZMOIC - NALDEMEDINA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/18/1291, 20190220
1889848 122019000063 Germany ⤷  Try a Trial PRODUCT NAME: NALDEMEDINE ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH DAS TOSYLAT SALZ; REGISTRATION NO/DATE: EU/1/18/1291 20190218
1889848 CR 2019 00035 Denmark ⤷  Try a Trial PRODUCT NAME: NALDEMEDIN ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, SAERLIGT TOSYLAT SALTET; REG. NO/DATE: EU/1/18/1291 20190220
1889848 CA 2019 00035 Denmark ⤷  Try a Trial 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 ⤷  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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.