Brovana is a drug owned by Lupin Inc. It is protected by 13 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 09, 2021. Details of Brovana'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). | |||
| US8110706 | Formoterol tartrate process and polymorph |
Nov, 2021
(3 years ago) |
Expired
|
| US6472563 | Formoterol tartrate process and polymorph |
Nov, 2021
(3 years ago) |
Expired
|
| US7145036 | Formoterol tartrate polymorph |
Nov, 2021
(3 years ago) |
Expired
|
| US6720453 | Formoterol tartrate polymorph |
Nov, 2021
(3 years ago) |
Expired
|
| US7348362 | Bronchodilating β-agonist compositions and methods |
Jun, 2021
(3 years ago) |
Expired
|
| US6667344 | Bronchodilating compositions and methods |
Jun, 2021
(3 years ago) |
Expired
|
| US6814953 | Bronchodilating compositions and methods |
Jun, 2021
(3 years ago) |
Expired
|
| US7473710 | Bronchodilating beta-agonist compositions and methods |
Jun, 2021
(3 years ago) |
Expired
|
| US7541385 | Bronchodilating β-agonist compositions and methods |
Jun, 2021
(3 years ago) |
Expired
|
| US7462645 | Bronchodilating beta-agonist compositions and methods |
Jun, 2021
(3 years ago) |
Expired
|
| US7465756 | Bronchodilating beta-agonist compositions and methods |
Jun, 2021
(3 years ago) |
Expired
|
| US6040344 | Formoterol process |
Nov, 2016
(8 years ago) |
Expired
|
| US6589508 | Methods and compositions for treating pulmonary disorders using optically pure (R,R) formoterol |
Apr, 2013
(11 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 Brovana's patents.
Latest Legal Activities on Brovana's Patents
Given below is the list of recent legal activities going on the following patents of Brovana.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 11 Mar, 2024 | US8110706 |
| Maintenance Fee Reminder Mailed Critical | 25 Sep, 2023 | US8110706 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 25 Sep, 2020 | US7541385 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 29 Jun, 2020 | US7473710 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 09 Jun, 2020 | US7465756 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 02 Jun, 2020 | US7462645 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 18 Sep, 2019 | US7348362 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 07 Aug, 2019 | US8110706 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 05 Jun, 2018 | US7145036 |
| Change in Power of Attorney (May Include Associate POA) Critical | 13 Nov, 2015 | US7465756 |
US patents provide insights into the exclusivity only within the United States, but Brovana 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 Brovana's family patents as well as insights into ongoing legal events on those patents.
Brovana's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Brovana's generic launch date based on the expiry of its last outstanding patent is estimated to be Nov 09, 2021 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Brovana Generic API suppliers:
Arformoterol Tartrate is the generic name for the brand Brovana. 13 different companies have already filed for the generic of Brovana, with Aiping Pharm Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Brovana's generic
How can I launch a generic of Brovana before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Brovana's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Brovana's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Brovana -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| Eq. 0.015 mg base/ 2 mL | 01 Oct, 2009 | 1 | 09 Nov, 2021 | Extinguished |
About Brovana
Brovana is a drug owned by Lupin Inc. It is used for maintenance treatment of bronchoconstriction in patients with COPD. Brovana uses Arformoterol Tartrate as an active ingredient. Brovana was launched by Lupin in 2006.
Approval Date:
Brovana was approved by FDA for market use on 06 October, 2006.
Active Ingredient:
Brovana uses Arformoterol Tartrate as the active ingredient. Check out other Drugs and Companies using Arformoterol Tartrate ingredient
Treatment:
Brovana is used for maintenance treatment of bronchoconstriction in patients with COPD.
Dosage:
Brovana is available in solution form for inhalation use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.015MG BASE/2ML | SOLUTION | Prescription | INHALATION |