Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Express Scripts
Harvard Business School
Boehringer Ingelheim
AstraZeneca
Merck
Baxter

Last Updated: June 28, 2022

SYMPROIC Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

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-two 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 May 13, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

< Available with Subscription >

  Sign up for a Free Trial

Summary for SYMPROIC
International Patents:72
US Patents:4
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 10
Patent Applications: 95
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 Action Opioid Antagonists

US Patents and Regulatory Information for SYMPROIC

SYMPROIC is protected by four US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of SYMPROIC is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystal of 6,7-unsaturated-7-carbamoyl morphinan derivative and method for producing the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

6,7-unsaturated-7-carbamoyl substituted morphinan derivative
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

6,7-unsaturated-7-carbamoyl substituted morphinan derivative
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF OPIOID-INDUCED CONSTIPATION

FDA Regulatory Exclusivity protecting SYMPROIC

NEW CHEMICAL ENTITY
Exclusivity Expiration: 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
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 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 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 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
>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: See Plans and Pricing

Denmark

Patent: 51075
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 51075
Estimated Expiration: See Plans and Pricing

Japan

Patent: 2013172297
Estimated Expiration: See Plans and Pricing

Patent: 18219
Estimated Expiration: See Plans and Pricing

Poland

Patent: 51075
Estimated Expiration: See Plans and Pricing

Spain

Patent: 03149
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 1350120
Estimated Expiration: See Plans and Pricing

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
Brazil 112013011593 cristal de derivado de morfinan 7-carbamoíla-6,7-insaturada e método para produzir o mesmo See Plans and Pricing
European Patent Office 1889848 DÉRIVÉ DE MORPHINANE SUBSTITUÉ PAR UN CARBAMOYLE EN POSITION 7 ET AYANT UNE INSAURATION EN POSITION 6,7 (6,7-UNSATURATED-7-CARBAMOYL SUBSTITUTED MORPHINAN DERIVATIVE) See Plans and Pricing
Hungary E044933 See Plans and Pricing
Australia 2011327113 Crystalline 6,7-unsaturated-7-carbamoyl morphinane derivative, and method for producing same See Plans and Pricing
Russian Federation 2607084 КРИСТАЛЛЫ ПРОИЗВОДНЫХ 6,7-НЕНАСЫЩЕННОГО-7-КАРБАМОИЛМОРФИНАНА И СПОСОБ ИХ ПОЛУЧЕНИЯ (CRYSTALS OF 6,7-UNSATURATED-7-CARBAMOYL MORPHINANE DERIVATIVE, AND METHOD FOR PRODUCING SAME) See Plans and Pricing
Lithuania 2639234 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SYMPROIC

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1889848 CR 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 122019000063 Germany See Plans and Pricing PRODUCT NAME: NALDEMEDINE ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH DAS TOSYLAT SALZ; REGISTRATION NO/DATE: EU/1/18/1291 20190218
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 2019C/533 Belgium See Plans and Pricing 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 1990036-4 Sweden See Plans and Pricing 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 2019/038 Ireland See Plans and Pricing PRODUCT NAME: NALDEMEDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR THE TOSYLATE SALT.; REGISTRATION NO/DATE: EU/1/18/1291 20190218
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Dow
Johnson and Johnson
Baxter
Express Scripts
Medtronic
McKinsey

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.