SYMPROIC Drug Patent Profile

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

See drug prices for SYMPROIC

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for SYMPROIC

NDA:

208854

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

A06AH	Peripheral opioid receptor antagonists
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

US Patents and Regulatory Information for SYMPROIC

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

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

FDA Regulatory Exclusivity protecting 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			Y	Y
Bdsi	SYMPROIC	naldemedine tosylate	TABLET;ORAL	208854-001	Mar 23, 2017		RX	Yes	Yes			Y	Y
Bdsi	SYMPROIC	naldemedine tosylate	TABLET;ORAL	208854-001	Mar 23, 2017		RX	Yes	Yes			Y	Y
Bdsi	SYMPROIC	naldemedine tosylate	TABLET;ORAL	208854-001	Mar 23, 2017		RX	Yes	Yes			Y	Y
Bdsi	SYMPROIC	naldemedine tosylate	TABLET;ORAL	208854-001	Mar 23, 2017		RX	Yes	Yes

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

Denmark

European Patent Office

Japan

Poland

Spain

Taiwan

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
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)
Hungary	E044933
Australia	2011327113	Crystalline 6,7-unsaturated-7-carbamoyl morphinane derivative, and method for producing same
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)
Lithuania	2639234

Supplementary Protection Certificates for SYMPROIC

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1889848	CR 2019 00035	Denmark		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		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		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		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		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		PRODUCT NAME: NALDEMEDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEREOF, IN PARTICULAR THE TOSYLATE SALT.; REGISTRATION NO/DATE: EU/1/18/1291 20190218