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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 eleven 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.
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
Summary for GOPRELTO
| US Patents: | 11 |
| 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 |
DrugPatentWatch® Estimated Generic Entry Opportunity Date for GOPRELTO
Generic Entry Date for GOPRELTO*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY 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.
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 fourteen US patents and one FDA Regulatory Exclusivity.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of GOPRELTO is ⤷ Try it Free.
This potential generic entry date is based on NEW CHEMICAL ENTITY.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting GOPRELTO
Pharmaceutical compositions and methods of using the same
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Patented Use: METHOD OF ADMINISTERING A LOCAL ANESTHETIC TO THE MUCOUS MEMBRANES
Pharmaceutical compositions and methods of using the same
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Pharmaceutical compositions and methods of using the same
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Patented Use: METHOD OF ADMINISTERING A LOCAL ANESTHETIC TO THE MUCOUS MEMBRANES
Pharmaceutical compositions and methods of using the same
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Patented Use: METHOD FOR THE INDUCTION OF LOCAL ANESTHESIA OF THE MUCOUS MEMBRANES
Pharmaceutical compositions and methods of using the same
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Patented Use: METHOD FOR THE INDUCTION OF LOCAL ANESTHESIA OF THE MUCOUS MEMBRANES
Pharmaceutical compositions and methods of using the same
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
Patented Use: METHOD FOR THE INDUCTION OF LOCAL ANESTHESIA OF THE MUCOUS MEMBRANES
Pharmaceutical compositions and methods of using the same
Patent Number: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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: ⤷ Try it Free
Patent Expiration: ⤷ Try it Free
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: ⤷ Try it Free
| 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 | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Genus Lifesciences | GOPRELTO | cocaine hydrochloride | SOLUTION;NASAL | 209963-001 | Dec 14, 2017 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Genus Lifesciences | GOPRELTO | cocaine hydrochloride | SOLUTION;NASAL | 209963-001 | Dec 14, 2017 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Genus Lifesciences | GOPRELTO | cocaine hydrochloride | SOLUTION;NASAL | 209963-001 | Dec 14, 2017 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | Y | ⤷ Try it Free | |||
| Genus Lifesciences | GOPRELTO | cocaine hydrochloride | SOLUTION;NASAL | 209963-001 | Dec 14, 2017 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Genus Lifesciences | GOPRELTO | cocaine hydrochloride | SOLUTION;NASAL | 209963-001 | Dec 14, 2017 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
