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SYMPROIC Drug Profile
When do Symproic patents expire, and what generic alternatives are available?
Symproic is a drug marketed by Shionogi Inc and is included in one NDA. There are three patents protecting this drug.
This drug has fifty patent family members in eighteen countries.
The generic ingredient in SYMPROIC is naldemedine tosylate. Two suppliers are listed for this compound. Additional details are available on the naldemedine tosylate profile page.
Summary for SYMPROIC
| International Patents: | 50 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 1 |
| 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
| (4R,4aS,7aR,12bS)-3-(cyclopropylmethyl)-4a,7,9-trihydroxy-N-[2-(3-phenyl-1,2,4-oxadiazol-5-yl)propan-2-yl]-1,2,4,5,7a,13-hexahydro-4,12-methanobenzofuro[3,2-e]isoquinoline-6-carboxamide |
| 03KSI6WLXH |
| 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 |
| 17-(cyclopropylmethyl)-6,7-didehydro-4,5alpha-epoxy-3,6,14-trihydroxy-N-(2-(3-phenyl- 1,2,4-oxadiazol-5-yl)propan-2-yl)morphinan-7-carboxamide |
| 916072-89-4 |
| AKOS032945757 |
| CHEMBL2105755 |
| CHEMBL3039508 |
| D0Q2HO |
| D0Q3PD |
| D10188 |
| D10478 |
| DB11691 |
| DTXSID10158809 |
| GTPL9150 |
| 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)- |
| 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 |
| Naldemedine (USAN/INN) |
| Naldemedine [USAN:INN] |
| naldemedine tosilate |
| Naldemedine tosylate |
| Naldemedine tosylate (JAN/USAN) |
| Naldemedine tosylate [USAN] |
| nalmedine |
| S 297995 |
| S-297,995 |
| S-297995 |
| SCHEMBL9880572 |
| UNII-03KSI6WLXH |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Shionogi Inc | SYMPROIC | naldemedine tosylate | TABLET;ORAL | 208854-001 | Mar 23, 2017 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | Y | ➤ Try a Free Trial | ||
| Shionogi Inc | SYMPROIC | naldemedine tosylate | TABLET;ORAL | 208854-001 | Mar 23, 2017 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Shionogi Inc | SYMPROIC | naldemedine tosylate | TABLET;ORAL | 208854-001 | Mar 23, 2017 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | Y | ➤ Try a Free 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 | Document Number | Estimated Expiration |
|---|---|---|
| Japan | WO2006126637 | ➤ Try a Free Trial |
| Denmark | 1889848 | ➤ Try a Free Trial |
| World Intellectual Property Organization (WIPO) | 2012063933 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
