Numbrino is a drug owned by Omnivium Pharmaceuticals Llc. It is protected by 11 US drug patents filed in 2023 out of which none have expired yet. Numbrino'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 Numbrino'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). | |||
| US10973811 | Pharmaceutical compositions and methods of using the same |
Feb, 2037
(12 years from now) | Active |
| US10894012 | Pharmaceutical compositions and methods of using the same |
Feb, 2037
(12 years from now) | Active |
| US10857095 | Pharmaceutical compositions and methods of using the same |
Feb, 2037
(12 years from now) | Active |
| US10420760 | Pharmaceutical compositions and methods of using the same |
Feb, 2037
(12 years from now) | Active |
| US10413505 | Pharmaceutical compositions and methods of using the same |
Feb, 2037
(12 years from now) | Active |
| US10149843 | Pharmaceutical compositions and methods of using the same |
Feb, 2037
(12 years from now) | Active |
| US9867815 | Pharmaceutical compositions and methods of using the same |
Feb, 2037
(12 years from now) | Active |
| US10933060 | Pharmaceutical compositions and methods of using the same |
Feb, 2037
(12 years from now) | Active |
| US11040032 | Pharmaceutical compositions and methods of using the same |
Feb, 2037
(12 years from now) | Active |
| US10231961 | Pharmaceutical compositions and methods of using the same |
Feb, 2037
(12 years from now) | Active |
| US10016407 | Pharmaceutical compositions and methods of using the same |
Feb, 2037
(12 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 Numbrino's patents.
Latest Legal Activities on Numbrino's Patents
Given below is the list of recent legal activities going on the following patents of Numbrino.
| 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 Numbrino. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Numbrino, 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 Numbrino.
Exclusivity Information
Numbrino holds 2 exclusivities. All of its exclusivities have expired in 2023. Details of Numbrino's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 14, 2022 |
| New Product(NP) | Jan 10, 2023 |
US patents provide insights into the exclusivity only within the United States, but Numbrino 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 Numbrino's family patents as well as insights into ongoing legal events on those patents.
Numbrino's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Numbrino'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)
Numbrino Generics:
There are no approved generic versions for Numbrino as of now.
Alternative Brands for Numbrino
Numbrino which is used for local anesthesia in patients with uveal melanoma and hepatic metastases, as well as those with hepatic or renal impairment., 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 | ||
|---|---|---|---|---|
| Noden Pharma |
| |||
About Numbrino
Numbrino is a drug owned by Omnivium Pharmaceuticals Llc. It is used for local anesthesia in patients with uveal melanoma and hepatic metastases, as well as those with hepatic or renal impairment. Numbrino uses Cocaine Hydrochloride as an active ingredient. Numbrino was launched by Omnivium Pharms in 2020.
Approval Date:
Numbrino was approved by FDA for market use on 10 January, 2020.
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 Numbrino is 10 January, 2020, its NCE-1 date is estimated to be 14 December, 2021.
Active Ingredient:
Numbrino uses Cocaine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Cocaine Hydrochloride ingredient
Treatment:
Numbrino is used for local anesthesia in patients with uveal melanoma and hepatic metastases, as well as those with hepatic or renal impairment.
Dosage:
Numbrino 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 |