Normocarb Hf 25 Patent Expiration

Normocarb Hf 25 is a drug owned by Dialysis Supplies Inc. It is protected by 2 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 04, 2023. Details of Normocarb Hf 25'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).
US5945449 Sterile bicarbonate concentrate
Oct, 2017

(6 years ago)

Expired
US7300674 Sterile low bicarbonate dialysis concentrate solutions
Mar, 2023

(1 year, 4 months ago)

Expired


FDA has granted several exclusivities to Normocarb Hf 25. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Normocarb Hf 25, 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 Normocarb Hf 25.

Exclusivity Information

Normocarb Hf 25 holds 1 exclusivities. All of its exclusivities have expired in 2013. Details of Normocarb Hf 25's exclusivity codes and their expiration dates are given below.


Drug Exclusivity Drug Exclusivity Expiration
Orphan Drug Exclusivity(ODE) Jul 26, 2013

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US patents provide insights into the exclusivity only within the United States, but Normocarb Hf 25 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 Normocarb Hf 25's family patents as well as insights into ongoing legal events on those patents.

Normocarb Hf 25's family patents

Normocarb Hf 25 has patent protection in a total of 4 countries. It's US patent count contributes only to 42.9% of its total global patent coverage. 2 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 Normocarb Hf 25.

Family Patents

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Generic Launch

Generic Release Date:

Normocarb Hf 25's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 04, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Normocarb Hf 25 Generics:

There are no approved generic versions for Normocarb Hf 25 as of now.





About Normocarb Hf 25

Normocarb Hf 25 is a drug owned by Dialysis Supplies Inc. It is used for continuous renal replacement therapy. Normocarb Hf 25 uses Magnesium Chloride; Sodium Bicarbonate; Sodium Chloride as an active ingredient. Normocarb Hf 25 was launched by Dialysis Sups in 2006.

Market Authorisation Date:

Normocarb Hf 25 was approved by FDA for market use on 26 July, 2006.

Active Ingredient:

Normocarb Hf 25 uses Magnesium Chloride; Sodium Bicarbonate; Sodium Chloride as the active ingredient. Check out other Drugs and Companies using Magnesium Chloride; Sodium Bicarbonate; Sodium Chloride ingredient

Treatment:

Normocarb Hf 25 is used for continuous renal replacement therapy.

Dosage:

Normocarb Hf 25 is available in solution form for injection use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
0.21GM/100ML;2.8GM/100ML;9.07GM/100ML SOLUTION Prescription INJECTION