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Details for New Drug Application (NDA): 209963
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NDA 209963 describes GOPRELTO, which is a drug marketed by Genus Lifesciences and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the GOPRELTO profile page.
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.
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 209963
| Tradename: | GOPRELTO |
| Applicant: | Genus Lifesciences |
| Ingredient: | cocaine hydrochloride |
| Patents: | 5 |
| Formulation / Manufacturing: | see details |
Generic Entry Opportunity Date for 209963
Generic Entry Date for 209963*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY 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 209963
Suppliers and Packaging for NDA: 209963
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GOPRELTO | cocaine hydrochloride | SOLUTION;NASAL | 209963 | NDA | Genus Lifesciences Inc. | 64950-359 | 64950-359-04 | 1 BOTTLE, GLASS in 1 CARTON (64950-359-04) > 4 mL in 1 BOTTLE, GLASS |
| GOPRELTO | cocaine hydrochloride | SOLUTION;NASAL | 209963 | NDA AUTHORIZED GENERIC | Genus Lifesciences Inc. | 64950-362 | 64950-362-04 | 1 BOTTLE, GLASS in 1 CARTON (64950-362-04) > 4 mL in 1 BOTTLE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;NASAL | Strength | 4% | ||||
| Approval Date: | Dec 14, 2017 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Dec 14, 2022 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | Start Trial | Patent Expiration: | Feb 7, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD OF ADMINISTERING A LOCAL ANESTHETIC PRIOR TO PERFORMING A DIAGNOSTIC OR SURGICAL PROCEDURE ON A SUBJECT WITH HEPATIC OR RENAL IMPAIRMENT | ||||||||
| Patent: | Start Trial | Patent Expiration: | Feb 7, 2037 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD FOR THE INDUCTION OF LOCAL ANESTHESIA PRIOR TO PERFORMING A PROCEDURE ON, THROUGH, OR ADJACENT TO THE MUCOUS MEMBRANES | ||||||||
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