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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:	6
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SYMPROIC

Generic Entry Date for SYMPROIC^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

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 ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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

6,7-unsaturated-7-carbamoyl substituted morphinan derivative
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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

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Glossary

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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	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Bdsi	SYMPROIC	naldemedine tosylate	TABLET;ORAL	208854-001	Mar 23, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Bdsi	SYMPROIC	naldemedine tosylate	TABLET;ORAL	208854-001	Mar 23, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Bdsi	SYMPROIC	naldemedine tosylate	TABLET;ORAL	208854-001	Mar 23, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
>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
Patent: PREPARATION CONTENANT UN DERIVE DE 7-CARBAMOYLMORPHINANE 6,7-INSATURE (PREPARATION CONTAINING 6,7-UNSATURATED-7-CARBAMOYL MORPHINAN DERIVATIVES)
Estimated Expiration: ⤷ Sign Up

Denmark

Patent: 51075
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 51075
Patent: PRÉPARATION CONTENANT UN DÉRIVÉ DE 7-CARBAMOYLMORPHINANE 6,7-INSATURÉ (PREPARATION CONTAINING 6,7-UNSATURATED-7-CARBAMOYLMORPHINAN DERIVATIVE)
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 2013172297
Patent: ６，７−不飽和−７−カルバモイルモルヒナン誘導体含有製剤
Estimated Expiration: ⤷ Sign Up

Patent: 18219
Estimated Expiration: ⤷ Sign Up

Poland

Patent: 51075
Estimated Expiration: ⤷ Sign Up

Spain

Patent: 03149
Estimated Expiration: ⤷ Sign Up

Taiwan

Patent: 1350120
Patent: Preparation containing 6,7-unsaturated-7-carbamoyl morphinan derivative
Estimated Expiration: ⤷ Sign Up

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.

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	3560929	DÉRIVÉ 6,7-INSATURATÉ-7-CARBAMOYL-MORPHINANE ET PROCÉDÉ POUR LE PRODUIRE (CRYSTALLINE 6,7-UNSATURATED-7-CARBAMOYL MORPHINANE DERIVATIVE, AND METHOD FOR PRODUCING SAME)	⤷ Sign Up
Portugal	2639234		⤷ Sign Up
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)	⤷ Sign Up
Denmark	1889848		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for SYMPROIC

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1889848	2019C/533	Belgium	⤷ Sign Up	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	132019000000093	Italy	⤷ Sign Up	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	⤷ Sign Up	PRODUCT NAME: NALDEMEDINE ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, EINSCHLIESSLICH DAS TOSYLAT SALZ; REGISTRATION NO/DATE: EU/1/18/1291 20190218
1889848	1990036-4	Sweden	⤷ Sign Up	PRODUCT NAME: NALDEMEDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR SOLVATE THEROF, IN PARTICULAR THE TOSYLATE SALT; REG. NO/DATE: EU/1/18/1291 20190220
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description