Utibron Neohaler is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 20 US drug patents filed from 2015 to 2018. Out of these, 2 drug patents are active and 18 have expired. Utibron 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 20, 2028. Details of Utibron 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 ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8182838 | Dry powder composition comprising co-jet milled particles for pulmonary inhalation |
Oct, 2028
(3 years from now) | Active |
| US8479730 | Inhaler device |
Oct, 2028
(3 years from now) | Active |
| US7736670 | Method of making particles for use in a pharmaceutical composition |
Jun, 2021
(3 years ago) |
Expired
|
| US8580306 | Particles for use in a pharmaceutical composition |
Jun, 2021
(3 years ago) |
Expired
|
| US9962338 | Method of making particles for use in a pharmaceutical composition |
Jun, 2021
(3 years ago) |
Expired
|
| US8956661 | Method of making composite particles for use in pharmaceutical compositions and composite particles and compositions thereof |
Jun, 2021
(3 years ago) |
Expired
|
| US8435567 | Pharmaceutical compositions of hydrophobic surface-modified active substance microparticles for inhalation |
Jun, 2021
(3 years ago) |
Expired
|
| US8303991 | Method of making particles for use in a pharmaceutical composition |
Jun, 2021
(3 years ago) |
Expired
|
| US8048451 | Pharmaceutical compositions for inhalation |
Jun, 2021
(3 years ago) |
Expired
|
| US9931304 | Method of making particles for use in a pharmaceutical composition |
Jun, 2021
(3 years ago) |
Expired
|
| US8029768 | Treatment of respiratory diseases |
Apr, 2021
(4 years ago) |
Expired
|
| US7229607 | Treatment of respiratory disease |
Apr, 2021
(4 years ago) |
Expired
|
| US7820694 | Beta-2-adrenoreceptor agonists |
Jun, 2020
(5 years ago) |
Expired
|
| US8796307 | Beta2-adrenoreceptor agonists |
Jun, 2020
(5 years ago) |
Expired
|
| US8283362 | Beta-2-adrenoreceptor agonists |
Jun, 2020
(5 years ago) |
Expired
|
| US8067437 | Beta-2-adrenoreceptor agonists |
Jun, 2020
(5 years ago) |
Expired
|
| US8658673 | BETA2-adrenoreceptor agonists |
Jun, 2020
(5 years ago) |
Expired
|
| US6582678 | Carrier particles for use in dry powder inhalers |
Apr, 2018
(7 years ago) |
Expired
|
| US6521260 | Carrier particles for use in dry powder inhalers |
Jan, 2016
(9 years ago) |
Expired
|
FDA has granted several exclusivities to Utibron Neohaler. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Utibron 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 Utibron Neohaler.
Exclusivity Information
Utibron Neohaler holds 2 exclusivities. All of its exclusivities have expired in 2018. Details of Utibron Neohaler's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Jul 01, 2016 |
| New Product(NP) | Oct 29, 2018 |
Several oppositions have been filed on Utibron Neohaler's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Utibron Neohaler's generic, the next section provides detailed information on ongoing and past EP oppositions related to Utibron Neohaler patents.
Utibron Neohaler's Oppositions Filed in EPO
Utibron Neohaler has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Aug 30, 2012, by Teva Uk Limited. This opposition was filed on patent number EP04768542A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP04727320A | Dec, 2018 | Teva UK Limited | Revoked |
| EP10181354A | Dec, 2018 | Teva UK Limited | Patent maintained as amended |
| EP04768542A | Aug, 2012 | Teva UK Limited | Revoked |
US patents provide insights into the exclusivity only within the United States, but Utibron 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 Utibron Neohaler's family patents as well as insights into ongoing legal events on those patents.
Utibron Neohaler's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Utibron Neohaler's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 20, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Utibron Neohaler Generics:
There are no approved generic versions for Utibron Neohaler as of now.
Alternative Brands for Utibron Neohaler
There are several other brand drugs in the same treatment category as Utibron Neohaler. 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 | ||
|---|---|---|---|---|
| Sumitomo Pharma Am |
| |||
About Utibron Neohaler
Utibron Neohaler is a drug owned by Novartis Pharmaceuticals Corp. Utibron Neohaler uses Glycopyrrolate; Indacaterol Maleate as an active ingredient. Utibron Neohaler was launched by Novartis in 2015.
Approval Date:
Utibron Neohaler was approved by FDA for market use on 29 October, 2015.
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 Utibron Neohaler is 29 October, 2015, its NCE-1 date is estimated to be 02 July, 2015.
Active Ingredient:
Utibron Neohaler uses Glycopyrrolate; Indacaterol Maleate as the active ingredient. Check out other Drugs and Companies using Glycopyrrolate; Indacaterol Maleate ingredient
Dosage:
Utibron Neohaler is available in powder form for inhalation use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 15.6MCG/INH;27.5MCG/INH | POWDER | Discontinued | INHALATION |