DrugPatentWatch Database Preview
SYMPROIC Drug Profile
Which patents cover Symproic, and what generic alternatives are available?
Symproic is a drug marketed by Bdsi and is included in one NDA. There are three patents protecting this drug.
This drug has fifty-three patent family members in twenty countries.
The generic ingredient in SYMPROIC is naldemedine tosylate. Three suppliers are listed for this compound. Additional details are available on the naldemedine tosylate profile page.
Summary for SYMPROIC
| International Patents: | 53 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 3 |
| Bulk Api Vendors: | 5 |
| Patent Applications: | 11 |
| Drug Prices: | Drug price information for SYMPROIC |
| DailyMed Link: | SYMPROIC at DailyMed |
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 |
Synonyms for SYMPROIC
| 1345728-04-2 |
| 17-(Cyclopropylmethyl)-6,7-didehydro-4,5a-epoxy-3,6,14-trihydroxy-N-(2-(3-phenyl-1,2,4-oxadiazol-5-yl)propan-2-yl)morphinan-7-carboxamide 4-methylbenzenesulfonic acid |
| CHEMBL3039508 |
| D10478 |
| DTXSID10158809 |
| Morphinan-7-carboxamide, 17-(cyclopropylmethyl)-6,7-didehydro-4,5-epoxy-3,6,14-trihydroxy-N-(1-methyl-1-(3-phenyl-1,2,4-oxadiazol-5-yl)ethyl)-,(5alpha)-, 4-methylbenzenesulfonate (1:1) |
| Naldemedine tosylate |
| Naldemedine tosylate (JAN/USAN) |
| Naldemedine tosylate [USAN] |
| SCHEMBL20720003 |
| UNII-V1N8F1RVVO |
| V1N8F1RVVO |
US Patents and Regulatory Information for 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 | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Bdsi | SYMPROIC | naldemedine tosylate | TABLET;ORAL | 208854-001 | Mar 23, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Bdsi | SYMPROIC | naldemedine tosylate | TABLET;ORAL | 208854-001 | Mar 23, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Bdsi | SYMPROIC | naldemedine tosylate | TABLET;ORAL | 208854-001 | Mar 23, 2017 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| >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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 103298819 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2012063933 | Start Trial |
| Ukraine | 115028 | Start Trial |
| Canada | 2814195 | Start Trial |
| Canada | 2609733 | Start Trial |
| Russian Federation | 2403255 | Start Trial |
| South Africa | 201301726 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SYMPROIC
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1889848 | 2019C/533 | Belgium | Start Trial | 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 | 122019000063 | Germany | Start Trial | PRODUCT NAME: NALDEMEDINE ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ ODER SOLVAT DAVON, INSBESONDERE DAS TOSYLAT SALZ; REGISTRATION NO/DATE: EU/1/18/1291 20190218 |
| 1889848 | CA 2019 00035 | Denmark | Start Trial | PRODUCT NAME: NALDEMEDIN ELLER ET FARMACEUTISK ACCEPTABELT SALT ELLER SOLVAT DERAF, SAERLIGT TOSYLAT SALTET; REG. NO/DATE: EU/1/18/1291 20190220 |
| 1889848 | 300996 | Netherlands | Start Trial | 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 |
