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GOPRELTO Drug Profile

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Which patents cover Goprelto, and what generic alternatives are available?

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

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

Summary for GOPRELTO

US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Formulation / Manufacturing:	see details
DailyMed Link:	GOPRELTO at DailyMed

Generic Entry Opportunity Date for GOPRELTO

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

209963

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.

Medical Subject Heading (MeSH) Categories for GOPRELTO

Anesthetics, Local

Dopamine Uptake Inhibitors

Vasoconstrictor Agents

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
Genus Lifesciences	GOPRELTO	cocaine hydrochloride	SOLUTION;NASAL	209963-001	Dec 14, 2017		RX	Yes	Yes
Genus Lifesciences	GOPRELTO	cocaine hydrochloride	SOLUTION;NASAL	209963-001	Dec 14, 2017		RX	Yes	Yes