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SYMPROIC Drug Profile
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» See Plans and PricingWhen 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 three patents protecting this drug.
This drug has sixty-two patent family members in twenty-four 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.
US ANDA Litigation and Generic Entry Outlook for Symproic
Symproic will be eligible for patent challenges on March 23, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be November 11, 2031. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
Summary for SYMPROIC
| International Patents: | 62 |
| 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
| (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 |
| CHEMBL2105755 |
| CHEMBL3039508 |
| compound 9k [PMID: 30446313] |
| D10188 |
| D10478 |
| DB11691 |
| DTXSID10158809 |
| GTPL9150 |
| J3.573.009E |
| 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] |
| Q27291424 |
| Q6960846 |
| S 297995 |
| S-297,995 |
| S-297995 |
| SCHEMBL20720003 |
| SCHEMBL9880572 |
| Symproic (TN) |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 |
|---|---|---|
| Poland | 2639234 | Start Trial |
| Mexico | 2007014588 | Start Trial |
| Australia | 2011327113 | Start Trial |
| Russian Federation | 2643807 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for SYMPROIC
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1889848 | 1990036-4 | Sweden | Start Trial | 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 | 132019000000093 | Italy | Start Trial | 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 | 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 | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
