Primatene Mist is a drug owned by Armstrong Pharmaceuticals Inc. It is protected by 1 US drug patent filed in 2018 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 26, 2026. Details of Primatene Mist'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). | |||
| US8367734 | Stable epinephrine suspension formulation with high inhalation delivery efficiency |
Jan, 2026
(1 year, 2 months 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 Primatene Mist's patents.
Latest Legal Activities on Primatene Mist's Patents
Given below is the list of recent legal activities going on the following patents of Primatene Mist.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 15 Jun, 2020 | US8367734 |
| Patent Issue Date Used in PTA Calculation Critical | 05 Feb, 2013 | US8367734 |
| Recordation of Patent Grant Mailed Critical | 05 Feb, 2013 | US8367734 |
| Issue Notification Mailed Critical | 16 Jan, 2013 | US8367734 |
| Dispatch to FDC | 08 Jan, 2013 | US8367734 |
| Application Is Considered Ready for Issue Critical | 07 Jan, 2013 | US8367734 |
| Issue Fee Payment Received Critical | 03 Jan, 2013 | US8367734 |
| Issue Fee Payment Verified Critical | 03 Jan, 2013 | US8367734 |
| Mail Miscellaneous Communication to Applicant | 27 Dec, 2012 | US8367734 |
| Printer Rush- No mailing | 19 Dec, 2012 | US8367734 |
FDA has granted several exclusivities to Primatene Mist. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Primatene Mist, 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 Primatene Mist.
Exclusivity Information
Primatene Mist holds 1 exclusivities. All of its exclusivities have expired in 2021. Details of Primatene Mist's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Nov 07, 2021 |
US patents provide insights into the exclusivity only within the United States, but Primatene Mist 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 Primatene Mist's family patents as well as insights into ongoing legal events on those patents.
Primatene Mist's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Primatene Mist's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 26, 2026 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Primatene Mist Generic API suppliers:
Epinephrine is the generic name for the brand Primatene Mist. 4 different companies have already filed for the generic of Primatene Mist, with Am Regent having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Primatene Mist's generic
Alternative Brands for Primatene Mist
Primatene Mist which is used for reducing inflammation and relieving pain., has several other brand drugs using the same active ingredient (Epinephrine). 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 | |||
|---|---|---|---|---|
| Adamis Pharms Corp |
| |||
| Ars Pharms Operation |
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| Baxter Hlthcare Corp |
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| Bpi Labs |
| |||
| Endo Operations |
| |||
| Impax |
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| Inforlife |
| |||
| Kaleo Inc |
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| Long Grove Pharms |
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| Mylan Speciality Lp |
| |||
| Vyteris |
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Apart from brand drugs containing the same ingredient, some generics have also been filed for Epinephrine, Primatene Mist's active ingredient. Check the complete list of approved generic manufacturers for Primatene Mist
About Primatene Mist
Primatene Mist is a drug owned by Armstrong Pharmaceuticals Inc. It is used for reducing inflammation and relieving pain. Primatene Mist uses Epinephrine as an active ingredient. Primatene Mist was launched by Armstrong Pharms in 2018.
Approval Date:
Primatene Mist was approved by FDA for market use on 07 November, 2018.
Active Ingredient:
Primatene Mist uses Epinephrine as the active ingredient. Check out other Drugs and Companies using Epinephrine ingredient
Treatment:
Primatene Mist is used for reducing inflammation and relieving pain.
Dosage:
Primatene Mist is available in aerosol, metered form for inhalation use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.125MG/INH | AEROSOL, METERED | Over the counter | INHALATION |