Goprelto is a drug owned by Noden Pharma Dac. It is protected by 12 US drug patents filed from 2018 to 2021 out of which none have expired yet. Goprelto's patents have been open to challenges since 14 December, 2021. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 07, 2037. Details of Goprelto's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9867815 | Pharmaceutical compositions and methods of using the same |
Feb, 2037
(11 years from now) | Active |
| US10420760 | Pharmaceutical compositions and methods of using the same |
Feb, 2037
(11 years from now) | Active |
| US10149843 | Pharmaceutical compositions and methods of using the same |
Feb, 2037
(11 years from now) | Active |
| US10933060 | Pharmaceutical compositions and methods of using the same |
Feb, 2037
(11 years from now) | Active |
| US10987347 | Pharmaceutical compositions and methods of using the same |
Feb, 2037
(11 years from now) | Active |
| US10894012 | Pharmaceutical compositions and methods of using the same |
Feb, 2037
(11 years from now) | Active |
| US10231961 | Pharmaceutical compositions and methods of using the same |
Feb, 2037
(11 years from now) | Active |
| US11040032 | Pharmaceutical compositions and methods of using the same |
Feb, 2037
(11 years from now) | Active |
| US10413505 | Pharmaceutical compositions and methods of using the same |
Feb, 2037
(11 years from now) | Active |
| US10016407 | Pharmaceutical compositions and methods of using the same |
Feb, 2037
(11 years from now) | Active |
| US10973811 | Pharmaceutical compositions and methods of using the same |
Feb, 2037
(11 years from now) | Active |
| US10857095 | Pharmaceutical compositions and methods of using the same |
Feb, 2037
(11 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Goprelto's patents.
Latest Legal Activities on Goprelto's Patents
Given below is the list of recent legal activities going on the following patents of Goprelto.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 03 Jul, 2024 | US10894012 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 22 May, 2024 | US10857095 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 08 Mar, 2023 | US10420760 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 01 Mar, 2023 | US10413505 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 14 Sep, 2022 | US10231961 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 13 Jun, 2022 | US10016407 (Litigated) |
| Surcharge for Late Payment, Large Entity | 13 Jun, 2022 | US10016407 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 09 Jun, 2022 | US10149843 |
| Maintenance Fee Reminder Mailed Critical | 28 Feb, 2022 | US10016407 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 14 Jan, 2022 | US9867815 (Litigated) |
FDA has granted several exclusivities to Goprelto. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Goprelto, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Goprelto.
Exclusivity Information
Goprelto holds 1 exclusivities. All of its exclusivities have expired in 2022. Details of Goprelto's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 14, 2022 |
US patents provide insights into the exclusivity only within the United States, but Goprelto is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Goprelto's family patents as well as insights into ongoing legal events on those patents.
Goprelto's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Goprelto's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 07, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Goprelto Generics:
There are no approved generic versions for Goprelto as of now.
Alternative Brands for Goprelto
Goprelto which is used for local anesthesia of mucous membranes in various patient populations., has several other brand drugs in the same treatment category and using the same active ingredient (Cocaine Hydrochloride). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | Treatment Area | ||
|---|---|---|---|---|
| Omnivium Pharms |
| |||
About Goprelto
Goprelto is a drug owned by Noden Pharma Dac. It is used for local anesthesia of mucous membranes in various patient populations. Goprelto uses Cocaine Hydrochloride as an active ingredient. Goprelto was launched by Noden Pharma in 2017.
Approval Date:
Goprelto was approved by FDA for market use on 14 December, 2017.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Goprelto is 14 December, 2017, its NCE-1 date is estimated to be 14 December, 2021.
Active Ingredient:
Goprelto uses Cocaine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Cocaine Hydrochloride ingredient
Treatment:
Goprelto is used for local anesthesia of mucous membranes in various patient populations.
Dosage:
Goprelto is available in solution form for nasal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 4% | SOLUTION | Prescription | NASAL |