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Last Updated: January 21, 2021

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GOPRELTO Drug Profile

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When do Goprelto patents expire, and when can generic versions of Goprelto launch?

Goprelto is a drug marketed by Genus Lifesciences and is included in one NDA. There are six patents protecting this drug.

The generic ingredient in GOPRELTO is cocaine hydrochloride. There are three drug master file entries for this compound. Additional details are available on the cocaine hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Goprelto

Goprelto will be eligible for patent challenges on December 14, 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 December 14, 2022. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for GOPRELTO
Generic Entry Opportunity Date for GOPRELTO
Generic Entry Date for GOPRELTO*:
Constraining patent/regulatory exclusivity:
FDA exclusivity
NDA:
Dosage:
SOLUTION;NASAL

*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.

US Patents and Regulatory Information for GOPRELTO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Genus Lifesciences GOPRELTO cocaine hydrochloride SOLUTION;NASAL 209963-001 Dec 14, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Genus Lifesciences GOPRELTO cocaine hydrochloride SOLUTION;NASAL 209963-001 Dec 14, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Genus Lifesciences GOPRELTO cocaine hydrochloride SOLUTION;NASAL 209963-001 Dec 14, 2017 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Genus Lifesciences GOPRELTO cocaine hydrochloride SOLUTION;NASAL 209963-001 Dec 14, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Genus Lifesciences GOPRELTO cocaine hydrochloride SOLUTION;NASAL 209963-001 Dec 14, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Genus Lifesciences GOPRELTO cocaine hydrochloride SOLUTION;NASAL 209963-001 Dec 14, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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