Seebri Neohaler is a drug owned by Novartis Pharmaceuticals Corp. It is protected by 15 US drug patents filed from 2015 to 2018. Out of these, 2 drug patents are active and 13 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 20, 2028. Details of Seebri 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 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 |
| US8435567 | Pharmaceutical compositions of hydrophobic surface-modified active substance microparticles for inhalation |
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
|
| US9962338 | Method of making particles for use in a pharmaceutical composition |
Jun, 2021
(3 years ago) |
Expired
|
| US7736670 | Method of making particles for use in a pharmaceutical composition |
Jun, 2021
(3 years ago) |
Expired
|
| US9931304 | 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
|
| US8048451 | Pharmaceutical compositions 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
|
| US8029768 | Treatment of respiratory diseases |
Apr, 2021
(4 years ago) |
Expired
|
| US7229607 | Treatment of respiratory disease |
Apr, 2021
(4 years ago) |
Expired
|
| US6528678 | Phosgene-free process for preparing carbamates |
Apr, 2018
(7 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 Seebri Neohaler. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Seebri 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 Seebri Neohaler.
Exclusivity Information
Seebri Neohaler holds 1 exclusivities. All of its exclusivities have expired in 2018. Details of Seebri Neohaler's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Oct 29, 2018 |
Several oppositions have been filed on Seebri 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 Seebri Neohaler's generic, the next section provides detailed information on ongoing and past EP oppositions related to Seebri Neohaler patents.
Seebri Neohaler's Oppositions Filed in EPO
Seebri 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 Seebri 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 Seebri Neohaler's family patents as well as insights into ongoing legal events on those patents.
Seebri Neohaler's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Seebri 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)
Seebri Neohaler Generic API suppliers:
Glycopyrrolate is the generic name for the brand Seebri Neohaler. 45 different companies have already filed for the generic of Seebri Neohaler, with Watson Labs having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Seebri Neohaler's generic
Alternative Brands for Seebri Neohaler
There are several other brand drugs in the same treatment category and using the same active ingredient (Glycopyrrolate) as Seebri 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 |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Glycopyrrolate. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | ||
|---|---|---|---|
| Astrazeneca |
| ||
| Astrazeneca Ab |
| ||
| Azurity |
| ||
| Casper Pharma Llc |
| ||
| Merz Pharms |
| ||
| Novartis |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Glycopyrrolate, Seebri Neohaler's active ingredient. Check the complete list of approved generic manufacturers for Seebri Neohaler
About Seebri Neohaler
Seebri Neohaler is a drug owned by Novartis Pharmaceuticals Corp. Seebri Neohaler uses Glycopyrrolate as an active ingredient. Seebri Neohaler was launched by Novartis in 2015.
Approval Date:
Seebri Neohaler was approved by FDA for market use on 29 October, 2015.
Active Ingredient:
Seebri Neohaler uses Glycopyrrolate as the active ingredient. Check out other Drugs and Companies using Glycopyrrolate ingredient
Dosage:
Seebri 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 | POWDER | Discontinued | INHALATION |