Dulera is a drug owned by Organon Llc. It is protected by 10 US drug patents filed from 2013 to 2019 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 12, 2023. Details of Dulera'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). | |||
|
US7566705 (Pediatric) | Combination of formoterol and mometasone furoate for asthma |
Nov, 2020
(4 years ago) |
Expired
|
|
US7067502 (Pediatric) | Combinations of formoterol and mometasone furoate for asthma |
Nov, 2020
(4 years ago) |
Expired
|
| US7067502 | Combinations of formoterol and mometasone furoate for asthma |
May, 2020
(4 years ago) |
Expired
|
| US7566705 | Combination of formoterol and mometasone furoate for asthma |
May, 2020
(4 years ago) |
Expired
|
| US6068832 | Chlorofluorocarbon-free mometasone furoate aerosol formulations |
Aug, 2017
(7 years ago) |
Expired
|
|
US5889015 (Pediatric) | Use of mometasone furoate for treating lower airway passage and lung diseases |
Jul, 2014
(10 years ago) |
Expired
|
|
US6057307 (Pediatric) | Use of mometasone furoate for treating airway passage and lung diseases |
Jul, 2014
(10 years ago) |
Expired
|
| US6057307 | Use of mometasone furoate for treating airway passage and lung diseases |
Jan, 2014
(10 years ago) |
Expired
|
| US6677323 | Use of mometasone furoate for treating airway passage and lung diseases |
Jan, 2014
(10 years ago) |
Expired
|
| US5889015 | Use of mometasone furoate for treating lower airway passage and lung diseases |
Jan, 2014
(10 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 Dulera's patents.
Latest Legal Activities on Dulera's Patents
Given below is the list of recent legal activities going on the following patents of Dulera.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 30 Aug, 2021 | US7566705 |
| Maintenance Fee Reminder Mailed Critical | 15 Mar, 2021 | US7566705 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 14 Dec, 2017 | US7067502 |
| Expire Patent Critical | 05 Feb, 2016 | US6677323 |
| Notice of Final Determination- Ineligible | 31 Jul, 2012 | US7067502 |
| Correspondence Address Change Critical | 26 Aug, 2011 | US6677323 |
| Letter from FDA or Dept of Agriculture re PTE application | 27 Apr, 2011 | US7067502 |
| Resp. to req. for info. sent under 37 CFR 1.750 | 28 Feb, 2011 | US7067502 |
| Requirement for information sent under 37 CFR 1.750 | 10 Jan, 2011 | US7067502 |
| Initial letter Re: PTE Application to regulating agency | 10 Jan, 2011 | US7067502 |
FDA has granted several exclusivities to Dulera. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Dulera, 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 Dulera.
Exclusivity Information
Dulera holds 4 exclusivities. All of its exclusivities have expired in 2023. Details of Dulera's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Combination(NC) | Jun 22, 2013 |
| M(M-214) | Dec 20, 2020 |
| Pediatric Exclusivity(PED) | Feb 12, 2023 |
| New Strength(NS) | Aug 12, 2022 |
US patents provide insights into the exclusivity only within the United States, but Dulera 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 Dulera's family patents as well as insights into ongoing legal events on those patents.
Dulera's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Dulera's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 12, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Dulera Generics:
There are no approved generic versions for Dulera as of now.
Alternative Brands for Dulera
Dulera which is used for managing and controlling symptoms of asthma., has several other brand drugs in the same treatment category . 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 | ||
|---|---|---|---|---|
| Taro |
| |||
About Dulera
Dulera is a drug owned by Organon Llc. It is used for managing and controlling symptoms of asthma. Dulera uses Formoterol Fumarate; Mometasone Furoate as an active ingredient. Dulera was launched by Organon Llc in 2019.
Approval Date:
Dulera was approved by FDA for market use on 12 August, 2019.
Active Ingredient:
Dulera uses Formoterol Fumarate; Mometasone Furoate as the active ingredient. Check out other Drugs and Companies using Formoterol Fumarate; Mometasone Furoate ingredient
Treatment:
Dulera is used for managing and controlling symptoms of asthma.
Dosage:
Dulera is available in aerosol, metered form for inhalation use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.005MG/INH;0.2MG/INH | AEROSOL, METERED | Prescription | INHALATION |
| 0.005MG/INH;0.1MG/INH | AEROSOL, METERED | Prescription | INHALATION |