Dymista is a drug owned by Mylan Specialty Lp. It is protected by 7 US drug patents filed from 2013 to 2018. Out of these, 2 drug patents are active and 5 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 24, 2026. Details of Dymista'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9259428 | Combination of azelastine and fluticasone for nasal administration |
Jun, 2023
(1 year, 1 month ago) |
Expired
|
| US9901585 | Combination of azelastine and fluticasone for nasal administration |
Jun, 2023
(1 year, 1 month ago) |
Expired
|
| US8163723 | Combination of azelastine and steroids |
Aug, 2023
(10 months ago) |
Expired
|
|
US9259428 (Pediatric) | Combination of azelastine and fluticasone for nasal administration |
Dec, 2023
(7 months ago) |
Expired
|
|
US8163723 (Pediatric) | Combination of azelastine and steroids |
Feb, 2024
(4 months ago) |
Expired
|
| US8168620 | Combination of azelastine and steroids |
Feb, 2026
(1 year, 6 months from now) | Active |
|
US8168620 (Pediatric) | Combination of azelastine and steroids |
Aug, 2026
(2 years from now) | Active |
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 Dymista's patents.
Latest Legal Activities on Dymista's Patents
Given below is the list of recent legal activities going on the following patents of Dymista.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Expire Patent | 03 Jun, 2024 | US8168620 (Litigated) |
| Expire Patent | 27 May, 2024 | US8163723 (Litigated) |
| Expire Patent | 25 Mar, 2024 | US9259428 (Litigated) |
| Maintenance Fee Reminder Mailed | 18 Dec, 2023 | US8168620 (Litigated) |
| Maintenance Fee Reminder Mailed | 11 Dec, 2023 | US8163723 (Litigated) |
| Maintenance Fee Reminder Mailed | 09 Oct, 2023 | US9259428 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 17 Aug, 2021 | US9901585 |
| Request for Trial Denied | 31 Jul, 2020 | US9259428 (Litigated) |
| Request for Trial Denied | 31 Jul, 2020 | US8163723 (Litigated) |
| Request for Trial Denied | 31 Jul, 2020 | US8168620 (Litigated) |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Dymista and ongoing litigations to help you estimate the early arrival of Dymista generic.
Dymista's Litigations
Dymista has been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Feb 02, 2017, against patent number US8168620. The petitioner Argentum Pharmaceuticals LLC, challenged the validity or infringement of this patent, with Cipla Limited as the respondent. Click below to track the latest information on how companies are challenging Dymista's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8163723 | January, 2020 | Terminated-Denied | Cipla Limited | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
| US8168620 | January, 2020 | Terminated-Denied | Cipla Limited | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
| US9259428 | January, 2020 | Terminated-Denied | Cipla Limited | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
| US9901585 | January, 2020 | Terminated-Denied | Cipla Limited | GlaxoSmithKline Consumer Healthcare Holdings (US) LLC |
| US8168620 | February, 2017 | Terminated-Settled | Cipla Limited | Argentum Pharmaceuticals LLC |
FDA has granted some exclusivities to Dymista. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Dymista, 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 Dymista.
Exclusivity Information
Dymista holds 3 exclusivities. All of its exclusivities have expired in 2018. Details of Dymista's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Combination(NC) | May 01, 2015 |
| New Patient Population(NPP) | Feb 20, 2018 |
| Pediatric Exclusivity(PED) | Aug 20, 2018 |
Several oppositions have been filed on Dymista'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 Dymista's generic, the next section provides detailed information on ongoing and past EP oppositions related to Dymista patents.
Dymista's oppositions filed in EPO
Dymista has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Jan 14, 2010, by Glaxo Group Limited. This opposition was filed on patent number EP03738280A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP09075100A | Apr, 2016 | Sanovel IIaç San. ve Tic. A.S. | Revoked |
| EP09075101A | Oct, 2014 | Abdi Ibrahim Ilac Sanayi ve Ticaret Anonim Sirketi | Revoked |
| EP09075101A | Oct, 2014 | Sanovel IIaç San. ve Tic. A.S. | Revoked |
| EP03738280A | Jan, 2010 | Glaxo Group Limited | Revoked |
US patents provide insights into the exclusivity only within the United States, but Dymista 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 Dymista's family patents as well as insights into ongoing legal events on those patents.
Dymista's family patents
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Generic Launch
Generic Release Date:
Dymista's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 24, 2026 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Dymista Generics:
Azelastine Hydrochloride; Fluticasone Propionate is the generic name for the brand Dymista. 2 different companies have already filed for the generic of Dymista, with Apotex having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Dymista's generic
How can I launch a generic of Dymista before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Dymista's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Dymista'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 Dymista -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 137 mcg/50 mcg per spray | 13 Jun, 2014 | 1 | 28 Apr, 2017 | 24 Aug, 2026 | Eligible |
About Dymista
Dymista is a drug owned by Mylan Specialty Lp. It is used for relieving symptoms of seasonal allergic rhinitis. Dymista uses Azelastine Hydrochloride; Fluticasone Propionate as an active ingredient. Dymista was launched by Mylan Speciality Lp in 2012.
Market Authorisation Date:
Dymista was approved by FDA for market use on 01 May, 2012.
Active Ingredient:
Dymista uses Azelastine Hydrochloride; Fluticasone Propionate as the active ingredient. Check out other Drugs and Companies using Azelastine Hydrochloride; Fluticasone Propionate ingredient
Treatment:
Dymista is used for relieving symptoms of seasonal allergic rhinitis.
Dosage:
Dymista is available in spray, metered form for nasal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.137MG/SPRAY;0.05MG/SPRAY | SPRAY, METERED | Prescription | NASAL |