GOPRELTO Drug Patent 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 twelve patents protecting this drug.
The generic ingredient in GOPRELTO is cocaine hydrochloride. There are three drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the cocaine hydrochloride profile page.
DrugPatentWatch® Generic Entry Outlook for Goprelto
Goprelto was eligible for patent challenges on December 14, 2021.
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
Summary for GOPRELTO
| US Patents: | 12 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 1 |
| Formulation / Manufacturing: | see details |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for GOPRELTO |
| What excipients (inactive ingredients) are in GOPRELTO? | GOPRELTO excipients list |
| DailyMed Link: | GOPRELTO at DailyMed |
Recent Clinical Trials for GOPRELTO
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Pharmaceutical Project Solutions, Inc. | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for GOPRELTO
US Patents and Regulatory Information for GOPRELTO
GOPRELTO is protected by fifteen US patents and one FDA Regulatory Exclusivity.
Patents protecting GOPRELTO
Pharmaceutical compositions and methods of using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF ADMINISTERING A LOCAL ANESTHETIC PRIOR TO PERFORMING A DIAGNOSTIC OR SURGICAL PROCEDURE ON A SUBJECT WITH HEPATIC OR RENAL IMPAIRMENT
Pharmaceutical compositions and methods of using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF ADMINISTERING A LOCAL ANESTHETIC TO THE MUCOUS MEMBRANES
Pharmaceutical compositions and methods of using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR THE INDUCTION OF LOCAL ANESTHESIA PRIOR TO PERFORMING A PROCEDURE ON, THROUGH, OR ADJACENT TO THE MUCOUS MEMBRANES
Pharmaceutical compositions and methods of using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Pharmaceutical compositions and methods of using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF ADMINISTERING A LOCAL ANESTHETIC TO THE MUCOUS MEMBRANES
Pharmaceutical compositions and methods of using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR THE INDUCTION OF LOCAL ANESTHESIA PRIOR TO PERFORMING A PROCEDURE ON, THROUGH, OR ADJACENT TO THE MUCOUS MEMBRANES
Pharmaceutical compositions and methods of using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR THE INDUCTION OF LOCAL ANESTHESIA OF THE MUCOUS MEMBRANES
Pharmaceutical compositions and methods of using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR THE INDUCTION OF LOCAL ANESTHESIA OF THE MUCOUS MEMBRANES
Pharmaceutical compositions and methods of using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD FOR THE INDUCTION OF LOCAL ANESTHESIA OF THE MUCOUS MEMBRANES
Pharmaceutical compositions and methods of using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF ADMINISTERING A LOCAL ANESTHETIC TO THE MUCOUS MEMBRANES IN PATIENTS WITH RENAL IMPAIRMENT
Pharmaceutical compositions and methods of using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF ADMINISTERING A LOCAL ANESTHETIC TO THE MUCOUS MEMBRANES IN PATIENTS WITH HEPATIC IMPAIRMENT
Pharmaceutical compositions and methods of using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Pharmaceutical compositions and methods of using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF ADMINISTERING A LOCAL ANESTHETIC TO THE MUCOUS MEMBRANES IN PATIENTS WITH HEPATIC IMPAIRMENT
Pharmaceutical compositions and methods of using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF ADMINISTERING A LOCAL ANESTHETIC TO THE MUCOUS MEMBRANES IN PATIENTS WITH RENAL IMPAIRMENT
Pharmaceutical compositions and methods of using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF ADMINISTERING A LOCAL ANESTHETIC TO THE MUCOUS MEMBRANES IN GERIATRIC PATIENTS
FDA Regulatory Exclusivity protecting GOPRELTO
NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing
| 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 | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Genus Lifesciences | GOPRELTO | cocaine hydrochloride | SOLUTION;NASAL | 209963-001 | Dec 14, 2017 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Genus Lifesciences | GOPRELTO | cocaine hydrochloride | SOLUTION;NASAL | 209963-001 | Dec 14, 2017 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Genus Lifesciences | GOPRELTO | cocaine hydrochloride | SOLUTION;NASAL | 209963-001 | Dec 14, 2017 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
| Genus Lifesciences | GOPRELTO | cocaine hydrochloride | SOLUTION;NASAL | 209963-001 | Dec 14, 2017 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
