Apidra is a drug owned by Sanofi Aventis Us Llc. It is protected by 4 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 Jan 25, 2023. Details of Apidra'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). | |||
| US6960561 | Zinc-free and low-zinc insulin preparations having improved stability |
Jan, 2023
(2 years ago) |
Expired
|
| US7696162 | Zinc-free and low-zinc insulin preparations having improved stability |
Mar, 2022
(3 years ago) |
Expired
|
| US7452860 | Zinc-free and low-zinc insulin preparations having improved stability |
Mar, 2022
(3 years ago) |
Expired
|
| US6221633 | Insulin derivatives having a rapid onset of action |
Jun, 2018
(7 years 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 Apidra's patents.
Latest Legal Activities on Apidra's Patents
Given below is the list of recent legal activities going on the following patents of Apidra.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 29 Sep, 2021 | US7696162 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 07 May, 2020 | US7452860 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 28 Sep, 2017 | US7696162 |
| Patent Issue Date Used in PTA Calculation
Critical | 13 Apr, 2010 | US7696162 |
| Recordation of Patent Grant Mailed
Critical | 13 Apr, 2010 | US7696162 |
| Issue Notification Mailed
Critical | 24 Mar, 2010 | US7696162 |
| Dispatch to FDC | 08 Mar, 2010 | US7696162 |
| Application Is Considered Ready for Issue
Critical | 06 Mar, 2010 | US7696162 |
| Issue Fee Payment Received
Critical | 26 Feb, 2010 | US7696162 |
| Issue Fee Payment Verified
Critical | 26 Feb, 2010 | US7696162 |
FDA has granted several exclusivities to Apidra. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Apidra, 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
Apidra.
Exclusivity Information
Apidra holds 1 exclusivities. All of its exclusivities have expired in 2011. Details of Apidra's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Patient Population(NPP) | Oct 24, 2011 |
US patents provide insights into the exclusivity only within the United States, but
Apidra 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 Apidra's family patents as well as insights into
ongoing legal events
on those patents.
Apidra's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Apidra's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 25, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Apidra Generics:
There are no approved generic versions for Apidra as of now.
Alternative Brands for Apidra
Apidra which is used for managing diabetes mellitus., has several other brand drugs in the same treatment category and using the same active ingredient (Insulin Glulisine Recombinant). 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 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Novo Nordisk Inc |
| |||||||||
| Sanofi Aventis Us |
| |||||||||
About Apidra
Apidra is a drug owned by Sanofi Aventis Us Llc. It is used for managing diabetes mellitus. Apidra uses Insulin Glulisine Recombinant as an active ingredient. Apidra was launched by Sanofi Aventis Us in 2004.
Approval Date:
Apidra was approved by FDA for market use on 16 April, 2004.
Active Ingredient:
Apidra uses Insulin Glulisine Recombinant as the active ingredient. Check out other Drugs and Companies using Insulin Glulisine Recombinant ingredient
Treatment:
Apidra is used for managing diabetes mellitus.
Dosage:
Apidra is available in injectable form for iv (infusion)-sc use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1000 UNITS/10ML (100 UNITS/ML) | INJECTABLE | Prescription | IV (INFUSION)-SC |
| 300 UNITS/3ML (100 UNITS/ML) | INJECTABLE | Prescription | IV (INFUSION)-SC |