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-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
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 |


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 Class | Opioid Antagonist |
Mechanism of Action | Opioid Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for SYMPROIC
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 |