Norditropin is a drug owned by Novo Nordisk Inc. It is protected by 3 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 Dec 15, 2015. Details of Norditropin'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). | |||
| US5849700 | Pharmaceutical formulation |
Dec, 2015
(8 years ago) |
Expired
|
| US5849704 | Pharmaceutical formulation |
Dec, 2015
(8 years ago) |
Expired
|
| US5633352 | Biosynthetic human growth hormone |
May, 2014
(10 years ago) |
Expired
|
FDA has granted several exclusivities to Norditropin. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Norditropin, 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.
Exclusivity Information
Norditropin holds 2 exclusivities. All of its exclusivities have expired in 2014. Details of Norditropin'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 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's family patents as well as insights into ongoing legal events on those patents.
Norditropin's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Norditropin's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 15, 2015 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Norditropin Generics:
There are no approved generic versions for Norditropin as of now.
Alternative Brands for Norditropin
Norditropin which is used for stimulating 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
Norditropin is a drug owned by Novo Nordisk Inc. It is used for stimulating growth in children with growth hormone deficiency. Norditropin uses Somatropin Recombinant as an active ingredient. Norditropin was launched by Novo Nordisk Inc in 2015.
Approval Date:
Norditropin was approved by FDA for market use on 23 January, 2015.
Active Ingredient:
Norditropin uses Somatropin Recombinant as the active ingredient. Check out other Drugs and Companies using Somatropin Recombinant ingredient
Treatment:
Norditropin is used for stimulating growth in children with growth hormone deficiency.
Dosage:
Norditropin is available in injectable form for injection use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 15MG/1.5ML | INJECTABLE | Discontinued | INJECTION |
| 10MG/1.5ML | INJECTABLE | Discontinued | INJECTION |
| 5MG/1.5ML | INJECTABLE | Discontinued | INJECTION |