Natroba is a drug owned by Cipher Pharmaceuticals Inc. It is protected by 5 US drug patents filed from 2013 to 2022. Out of these, 1 drug patents are active and 4 have expired. Natroba's patents have been open to challenges since 18 January, 2015. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 25, 2033. Details of Natroba'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). | |||
| US9895388 | Methods and compositions useful for controlling cutaneous mites |
Nov, 2033
(8 years from now) | Active |
| US7030095 | Pediculicidal and ovacidal treatment compositions and methods for killing head lice and their eggs |
Jul, 2021
(4 years ago) |
Expired
|
| US6063771 | Formulations for controlling human lice |
Jun, 2019
(6 years ago) |
Expired
|
| US6342482 | Formulations for controlling human lice |
Jun, 2019
(6 years ago) |
Expired
|
| US5496931 | Insecticide and miticide A83543 compounds and their method of production by fermentation |
Mar, 2013
(12 years ago) |
Expired
|
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 Natroba's patents.
Latest Legal Activities on Natroba's Patents
Given below is the list of recent legal activities going on the following patents of Natroba.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Yr, Small Entity | 11 Aug, 2021 | US9895388 |
| Expire Patent Critical | 14 May, 2018 | US7030095 |
| Application ready for PDX access by participating foreign offices Critical | 20 Feb, 2018 | US9895388 |
| Recordation of Patent Grant Mailed Critical | 20 Feb, 2018 | US9895388 |
| Patent Issue Date Used in PTA Calculation Critical | 20 Feb, 2018 | US9895388 |
| Email Notification Critical | 01 Feb, 2018 | US9895388 |
| Issue Notification Mailed Critical | 31 Jan, 2018 | US9895388 |
| Dispatch to FDC | 12 Jan, 2018 | US9895388 |
| Application Is Considered Ready for Issue Critical | 12 Jan, 2018 | US9895388 |
| Issue Fee Payment Verified Critical | 10 Jan, 2018 | US9895388 |
FDA has granted several exclusivities to Natroba. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Natroba, 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 Natroba.
Exclusivity Information
Natroba holds 3 exclusivities. All of its exclusivities have expired in 2024. Details of Natroba's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jan 18, 2016 |
| M(M-152) | Nov 30, 2017 |
| New Indication(I-858) | Apr 28, 2024 |
US patents provide insights into the exclusivity only within the United States, but Natroba 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 Natroba's family patents as well as insights into ongoing legal events on those patents.
Natroba's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Natroba's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Nov 25, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Natroba Generics:
There are no approved generic versions for Natroba as of now.
About Natroba
Natroba is a drug owned by Cipher Pharmaceuticals Inc. It is used for treating scabies mite infestations and head lice infestations. Natroba uses Spinosad as an active ingredient. Natroba was launched by Cipher in 2011.
Approval Date:
Natroba was approved by FDA for market use on 18 January, 2011.
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 Natroba is 18 January, 2011, its NCE-1 date is estimated to be 18 January, 2015.
Active Ingredient:
Natroba uses Spinosad as the active ingredient. Check out other Drugs and Companies using Spinosad ingredient
Treatment:
Natroba is used for treating scabies mite infestations and head lice infestations.
Dosage:
Natroba is available in suspension form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.9% | SUSPENSION | Prescription | TOPICAL |