GOPRELTO Drug Patent Profile
When do Goprelto patents expire, and when can generic versions of Goprelto launch?
Goprelto is a drug marketed by Lxo Ireland and is included in one NDA. There are twelve patents protecting this drug.
The generic ingredient in GOPRELTO is cocaine hydrochloride. There is one drug master file entry 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 February 7, 2037. This may change due to patent challenges or generic licensing.
There have been eighteen patent litigation cases 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
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for GOPRELTO?
- What are the global sales for GOPRELTO?
- What is Average Wholesale Price for GOPRELTO?
Summary for GOPRELTO
| US Patents: | 12 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 34 |
| Clinical Trials: | 2 |
| Patent Applications: | 647 |
| 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 Loss of Exclusivity (LOE) Date for GOPRELTO
Generic Entry Date for GOPRELTO*:
Constraining patent/regulatory 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.
Recent Clinical Trials for GOPRELTO
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Omnivium Pharmaceuticals LLC | PHASE3 |
| Pharmaceutical Project Solutions, Inc. | Phase 4 |
US Patents and Regulatory Information for GOPRELTO
GOPRELTO is protected by fifteen US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of GOPRELTO is ⤷ Start Trial.
This potential generic entry date is based on patent ⤷ Start Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lxo Ireland | GOPRELTO | cocaine hydrochloride | SOLUTION;NASAL | 209963-001 | Dec 14, 2017 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Lxo Ireland | GOPRELTO | cocaine hydrochloride | SOLUTION;NASAL | 209963-001 | Dec 14, 2017 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Lxo Ireland | GOPRELTO | cocaine hydrochloride | SOLUTION;NASAL | 209963-001 | Dec 14, 2017 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Lxo Ireland | GOPRELTO | cocaine hydrochloride | SOLUTION;NASAL | 209963-001 | Dec 14, 2017 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Lxo Ireland | GOPRELTO | cocaine hydrochloride | SOLUTION;NASAL | 209963-001 | Dec 14, 2017 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Lxo Ireland | 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 |
