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
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for SYMPROIC?
- What are the global sales for SYMPROIC?
- What is Average Wholesale Price for SYMPROIC?
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: | 6 |
Drug Prices: | Drug price information for SYMPROIC |
What excipients (inactive ingredients) are in SYMPROIC? | SYMPROIC excipients list |
DailyMed Link: | SYMPROIC at DailyMed |


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 Class | Opioid Antagonist |
Mechanism of Action | Opioid 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 for Free.
This potential generic entry date is based on patent ⤷ Try for Free.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
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 for Free | ⤷ Try for Free | Y | Y | ⤷ Try for Free | ||
Bdsi | SYMPROIC | naldemedine tosylate | TABLET;ORAL | 208854-001 | Mar 23, 2017 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | Y | Y | ⤷ Try for Free | ||
Bdsi | SYMPROIC | naldemedine tosylate | TABLET;ORAL | 208854-001 | Mar 23, 2017 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | Y | Y | ⤷ Try for Free | ||
Bdsi | SYMPROIC | naldemedine tosylate | TABLET;ORAL | 208854-001 | Mar 23, 2017 | RX | Yes | Yes | ⤷ Try for Free | ⤷ Try for Free | Y | Y | ⤷ Try for Free | ||
>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 for Free
Denmark
Patent: 51075
Estimated Expiration: ⤷ Try for Free
European Patent Office
Patent: 51075
Estimated Expiration: ⤷ Try for Free
Japan
Patent: 2013172297
Estimated Expiration: ⤷ Try for Free
Patent: 18219
Estimated Expiration: ⤷ Try for Free
Poland
Patent: 51075
Estimated Expiration: ⤷ Try for Free
Spain
Patent: 03149
Estimated Expiration: ⤷ Try for Free
Taiwan
Patent: 1350120
Estimated Expiration: ⤷ Try for Free
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 |
---|---|---|---|
Slovenia | 2639234 | ⤷ Try for Free | |
South Korea | 20080014791 | 6,7-UNSATURATED-7-CARBAMOYL SUBSTITUTED MORPHINAN DERIVATIVE | ⤷ Try for Free |
Spain | 2525215 | ⤷ Try for Free | |
Philippines | 12015501226 | CRYSTALLINE 6,7-UNSATURATED-7-CARBAMOYL MORPHINANE DERIVATIVE, AND METHOD FOR PRODUCING THE SAME | ⤷ Try for Free |
South Korea | 20130121119 | CRYSTALLINE 6,7-UNSATURATED-7-CARBAMOYL MORPHINANE DERIVATIVE, AND METHOD FOR PRODUCING SAME | ⤷ Try for Free |
Taiwan | 201350120 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SYMPROIC
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1889848 | 19C1042 | France | ⤷ Try for 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 | 2019/038 | Ireland | ⤷ Try for Free | PRODUCT NAME: NALDEMEDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR THE TOSYLATE SALT.; REGISTRATION NO/DATE: EU/1/18/1291 20190218 |
1889848 | C201930045 | Spain | ⤷ Try for 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 | 122019000063 | Germany | ⤷ Try for Free | PRODUCT NAME: NALDEMEDINE ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH DAS TOSYLAT SALZ; REGISTRATION NO/DATE: EU/1/18/1291 20190218 |
1889848 | SPC/GB19/050 | United Kingdom | ⤷ Try for Free | 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 | 300996 | Netherlands | ⤷ Try for Free | PRODUCT NAME: NALDEMEDINE DAN WEL EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, IN HET BIJZONDER HET TOSYLAATZOUT; REGISTRATION NO/DATE: EU/1/18/1291 20190220 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for the Drug: Symproic
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