Arcapta Neohaler is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 5 US drug patents filed from 2013 to 2015. Out of these, 2 drug patents are active and 3 have expired. Arcapta Neohaler's patents have been open to challenges since 02 July, 2015. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 11, 2028. Details of Arcapta Neohaler's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US6878721 | Beta2-adrenoceptor agonists |
Feb, 2025
(3 months from now) | Active |
| US8658673 | BETA2-adrenoreceptor agonists |
Jun, 2020
(4 years ago) |
Expired
|
| US8796307 | Beta2-adrenoreceptor agonists |
Jun, 2020
(4 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8479730 | Inhaler device |
Oct, 2028
(3 years from now) | Active |
| US8067437 | Beta-2-adrenoreceptor agonists |
Jun, 2020
(4 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 Arcapta Neohaler's patents.
Latest Legal Activities on Arcapta Neohaler's Patents
Given below is the list of recent legal activities going on the following patents of Arcapta Neohaler.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 01 Jan, 2024 | US8067437 |
| Maintenance Fee Reminder Mailed Critical | 17 Jul, 2023 | US8067437 |
| Expire Patent Critical | 12 Sep, 2022 | US8796307 |
| Expire Patent Critical | 04 Apr, 2022 | US8658673 |
| Maintenance Fee Reminder Mailed Critical | 28 Mar, 2022 | US8796307 |
| Maintenance Fee Reminder Mailed Critical | 18 Oct, 2021 | US8658673 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 23 Dec, 2020 | US8479730 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 May, 2019 | US8067437 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 25 Jan, 2018 | US8796307 |
| Patent Term Extension Certificate Critical | 23 Feb, 2016 | US6878721 |
FDA has granted several exclusivities to Arcapta Neohaler. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Arcapta Neohaler, 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 Arcapta Neohaler.
Exclusivity Information
Arcapta Neohaler holds 1 exclusivities. All of its exclusivities have expired in 2016. Details of Arcapta Neohaler's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 01, 2016 |
US patents provide insights into the exclusivity only within the United States, but Arcapta Neohaler 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 Arcapta Neohaler's family patents as well as insights into ongoing legal events on those patents.
Arcapta Neohaler's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Arcapta Neohaler's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 11, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Arcapta Neohaler Generics:
There are no approved generic versions for Arcapta Neohaler as of now.
Alternative Brands for Arcapta Neohaler
Arcapta Neohaler which is used for managing airflow obstruction in patients with COPD., has several other brand drugs using the same active ingredient (Indacaterol Maleate). 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 | |
|---|---|---|
| Novartis |
|
About Arcapta Neohaler
Arcapta Neohaler is a drug owned by Novartis Pharmaceuticals Corp. It is used for managing airflow obstruction in patients with COPD. Arcapta Neohaler uses Indacaterol Maleate as an active ingredient. Arcapta Neohaler was launched by Novartis in 2011.
Approval Date:
Arcapta Neohaler was approved by FDA for market use on 01 July, 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 Arcapta Neohaler is 01 July, 2011, its NCE-1 date is estimated to be 02 July, 2015.
Active Ingredient:
Arcapta Neohaler uses Indacaterol Maleate as the active ingredient. Check out other Drugs and Companies using Indacaterol Maleate ingredient
Treatment:
Arcapta Neohaler is used for managing airflow obstruction in patients with COPD.
Dosage:
Arcapta Neohaler is available in powder form for inhalation use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 75MCG BASE | POWDER | Discontinued | INHALATION |