Dymista Patent Expiration

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 drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8168620

(Pediatric)

Combination of azelastine and steroids
Aug, 2026

(1 year, 8 months from now)

Active
US8168620 Combination of azelastine and steroids
Feb, 2026

(1 year, 2 months from now)

Active
US8163723

(Pediatric)

Combination of azelastine and steroids
Feb, 2024

(9 months ago)

Expired
US9259428

(Pediatric)

Combination of azelastine and fluticasone for nasal administration
Dec, 2023

(a year ago)

Expired
US8163723 Combination of azelastine and steroids
Aug, 2023

(1 year, 3 months ago)

Expired
US9259428 Combination of azelastine and fluticasone for nasal administration
Jun, 2023

(1 year, 6 months ago)

Expired
US9901585 Combination of azelastine and fluticasone for nasal administration
Jun, 2023

(1 year, 6 months 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 Dymista's patents.

Given below is the list of recent legal activities going on the following patents of Dymista.

Activity Date Patent Number
Patent litigations
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 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 of this patent, with Cipla Limited as the respondent. Click below to track the latest information on how companies are challenging Dymista's patents.

Last updated on December 10, 2024
Patent Proceeding Filing Date Status Respondent Petitioner
Patent litigations
US8163723 January, 2020 Terminated-Denied
(31 Jul, 2020)
Cipla Limited GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
US8168620 January, 2020 Terminated-Denied
(31 Jul, 2020)
Cipla Limited GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
US9259428 January, 2020 Terminated-Denied
(31 Jul, 2020)
Cipla Limited GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
US9901585 January, 2020 Terminated-Denied
(31 Jul, 2020)
Cipla Limited GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
US8168620 February, 2017 Terminated-Settled
(21 May, 2018)
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

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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
Patent litigations
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

Dymista has patent protection in a total of 27 countries. It's US patent count contributes only to 16.1% of its total global patent coverage. 9 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Dymista.

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 Generic API suppliers:

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.

Approval 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