Norditropin Nordiflex is a drug owned by Novo Nordisk Inc. It is protected by 7 US drug patents filed from 2013 to 2014 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jan 21, 2021. Details of Norditropin Nordiflex'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). | |||
| USRE41956 | Dose setting limiter |
Jan, 2021
(3 years ago) |
Expired
|
| US6235004 | Injection syringe |
Jan, 2019
(5 years ago) |
Expired
|
| US6004297 | Injection syringe |
Jan, 2019
(5 years ago) |
Expired
|
| USRE43834 | Injection syringe |
Jan, 2019
(5 years ago) |
Expired
|
| US8841252 | Pharmaceutical formulation |
Dec, 2017
(6 years ago) |
Expired
|
| US5849700 | Pharmaceutical formulation |
Dec, 2015
(8 years ago) |
Expired
|
| US5849704 | Pharmaceutical formulation |
Dec, 2015
(8 years ago) |
Expired
|
FDA has granted several exclusivities to Norditropin Nordiflex. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Norditropin Nordiflex, 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 Norditropin Nordiflex.
Exclusivity Information
Norditropin Nordiflex holds 2 exclusivities. All of its exclusivities have expired in 2014. Details of Norditropin Nordiflex's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-572) | Oct 31, 2011 |
| Orphan Drug Exclusivity(ODE) | May 31, 2014 |
US patents provide insights into the exclusivity only within the United States, but Norditropin Nordiflex 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 Norditropin Nordiflex's family patents as well as insights into ongoing legal events on those patents.
Norditropin Nordiflex's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Norditropin Nordiflex's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jan 21, 2021 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Norditropin Nordiflex Generics:
There are no approved generic versions for Norditropin Nordiflex as of now.
Alternative Brands for Norditropin Nordiflex
Norditropin Nordiflex which is used for promoting growth in children with growth hormone deficiency., has several other brand drugs in the same treatment category and using the same active ingredient (Somatropin 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 | ||
|---|---|---|---|---|
| Genentech |
| |||
| Novo Nordisk Inc |
| |||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Somatropin Recombinant. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |||
|---|---|---|---|---|
| Emd Serono |
| |||
| Genentech |
| |||
| Novo Nordisk Inc |
| |||
| Pharmacia And Upjohn |
|
About Norditropin Nordiflex
Norditropin Nordiflex is a drug owned by Novo Nordisk Inc. It is used for promoting growth in children with growth hormone deficiency. Norditropin Nordiflex uses Somatropin Recombinant as an active ingredient. Norditropin Nordiflex was launched by Novo Nordisk Inc in 2015.
Approval Date:
Norditropin Nordiflex was approved by FDA for market use on 23 January, 2015.
Active Ingredient:
Norditropin Nordiflex uses Somatropin Recombinant as the active ingredient. Check out other Drugs and Companies using Somatropin Recombinant ingredient
Treatment:
Norditropin Nordiflex is used for promoting growth in children with growth hormone deficiency.
Dosage:
Norditropin Nordiflex is available in injectable form for injection use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10MG/1.5ML | INJECTABLE | Discontinued | INJECTION |
| 15MG/1.5ML | INJECTABLE | Discontinued | INJECTION |
| 30MG/3ML | INJECTABLE | Prescription | INJECTION |
| 5MG/1.5ML | INJECTABLE | Discontinued | INJECTION |