Dawnzera (autoinjector) Patent Expiration

Dawnzera (autoinjector) is a drug owned by Ionis Pharmaceuticals Inc. It is protected by 5 US drug patents filed in 2025 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be May 01, 2035. Details of Dawnzera (autoinjector)'s patents and their expiration are given in the table below.

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Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
US10294477 Compositions And Methods For Modulating Pkk Expression
May, 2035

(9 years from now)

Active
US9670492 Modulation Of Prekallikrein (Pkk) Expression
Aug, 2034

(8 years from now)

Active
US9127276 Conjugated antisense compounds and their use
May, 2034

(8 years from now)

Active
US9181549 Conjugated antisense compounds and their use
May, 2034

(8 years from now)

Active
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9315811 Methods For Modulating Kallikrein (Klkb1) Expression
Oct, 2032

(6 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 Dawnzera (autoinjector)'s patents.

Given below is the list of recent legal activities going on the following patents of Dawnzera (autoinjector).

Activity Date Patent Number
Patent litigations
Change in Power of Attorney (May Include Associate POA) 02 Sep, 2025 US9315811
Email Notification 02 Sep, 2025 US9315811
Email Notification 21 Mar, 2025 US9670492
Change in Power of Attorney (May Include Associate POA) 21 Mar, 2025 US9670492
Email Notification 21 Mar, 2025 US10294477
Change in Power of Attorney (May Include Associate POA) 21 Mar, 2025 US10294477
Payment of Maintenance Fee, 8th Year, Large Entity 20 Nov, 2024 US9670492
Patent Term Extension Application under 35 USC 156 Filed 16 Feb, 2024 US9127276
Patent Term Extension Application under 35 USC 156 Filed 16 Feb, 2024 US9181549
Payment of Maintenance Fee, 8th Year, Large Entity 04 Oct, 2023 US9315811

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US patents provide insights into the exclusivity only within the United States, but Dawnzera (autoinjector) 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 Dawnzera (autoinjector)'s family patents as well as insights into ongoing legal events on those patents.

Dawnzera (autoinjector)'s Family Patents


Family Patents

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Generic Launch

Generic Release Date:

Dawnzera (autoinjector)'s generic launch date based on the expiry of its last outstanding patent is estimated to be May 01, 2035 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Dawnzera (autoinjector) Generics:

There are no approved generic versions for Dawnzera (autoinjector) as of now.

Alternative Brands for Dawnzera (autoinjector)

There are several other brand drugs in the same treatment category as Dawnzera (autoinjector). 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
Biocryst
Orladeyo Used for preventing attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years of age and older.





About Dawnzera (autoinjector)

Dawnzera (Autoinjector) is a drug owned by Ionis Pharmaceuticals Inc. Dawnzera (Autoinjector) uses Donidalorsen Sodium as an active ingredient. Dawnzera (Autoinjector) was launched by Ionis in 2025.

Approval Date:

Dawnzera (autoinjector) was approved by FDA for market use on 21 August, 2025.

Active Ingredient:

Dawnzera (autoinjector) uses Donidalorsen Sodium as the active ingredient. Check out other Drugs and Companies using Donidalorsen Sodium ingredient

Dosage:

Dawnzera (autoinjector) is available in solution form for subcutaneous use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
EQ 80MG BASE/0.8ML (EQ 80MG BASE/0.8ML) SOLUTION Prescription SUBCUTANEOUS