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Last Updated: April 5, 2020

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SYMPROIC Drug 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 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

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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
Drug patent expirations by year for SYMPROIC
Drug Prices for SYMPROIC

See drug prices for SYMPROIC

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 ClassOpioid Antagonist
Mechanism of ActionOpioid 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

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

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Serving leading biopharmaceutical companies globally:

Dow
Johnson and Johnson
Baxter
Express Scripts
Medtronic
McKinsey

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