Hemady Patent Expiration

Hemady is a drug owned by Dexcel Pharma Technologies Ltd. It is protected by 2 US drug patents filed from 2020 to 2022 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 18, 2037. Details of Hemady'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).
US11304961 Compositions comprising dexamethasone
Dec, 2037

(13 years from now)

Active
US10537585 Compositions comprising dexamethasone
Dec, 2037

(13 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 Hemady's patents.

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

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 4th Year, Large Entity 13 Jul, 2023 US10537585
Patent Issue Date Used in PTA Calculation 19 Apr, 2022 US11304961
Recordation of Patent Grant Mailed 19 Apr, 2022 US11304961
Email Notification 31 Mar, 2022 US11304961
Issue Notification Mailed 30 Mar, 2022 US11304961
Application Is Considered Ready for Issue 28 Mar, 2022 US11304961
Dispatch to FDC 28 Mar, 2022 US11304961
Issue Fee Payment Verified 07 Mar, 2022 US11304961
Issue Fee Payment Received 07 Mar, 2022 US11304961
Mail Notice of Allowance 02 Mar, 2022 US11304961


FDA has granted several exclusivities to Hemady. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Hemady, 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 Hemady.

Exclusivity Information

Hemady holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2026. Details of Hemady's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE-271) Oct 03, 2026

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

Hemady's Family Patents

Hemady has patent protection in a total of 2 countries. It has a significant patent presence in the US with 66.7% of its patents being US patents. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree for Hemady.

Family Patents

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Generic Launch

Generic Release Date:

Hemady's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 18, 2037 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Hemady Generic API suppliers:

Dexamethasone is the generic name for the brand Hemady. 30 different companies have already filed for the generic of Hemady, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Hemady's generic

Alternative Brands for Hemady

Hemady which is used for treating adults with multiple myeloma., has several other brand drugs using the same active ingredient (Dexamethasone). 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
Abbvie
Ozurdex
Eyepoint Pharms
Dexycu Kit
Harrow Eye
Tobradex St
Ocular Therapeutix
Dextenza
Sandoz
Ciprodex


Apart from brand drugs containing the same ingredient, some generics have also been filed for Dexamethasone, Hemady's active ingredient. Check the complete list of approved generic manufacturers for Hemady





About Hemady

Hemady is a drug owned by Dexcel Pharma Technologies Ltd. It is used for treating adults with multiple myeloma. Hemady uses Dexamethasone as an active ingredient. Hemady was launched by Dexcel in 2019.

Approval Date:

Hemady was approved by FDA for market use on 03 October, 2019.

Active Ingredient:

Hemady uses Dexamethasone as the active ingredient. Check out other Drugs and Companies using Dexamethasone ingredient

Treatment:

Hemady is used for treating adults with multiple myeloma.

Dosage:

Hemady is available in tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
20MG TABLET Prescription ORAL