Norditropin Flexpro is a drug owned by Novo Nordisk Inc. It is protected by 23 US drug patents filed from 2013 to 2019. Out of these, 14 drug patents are active and 9 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 01, 2032. Details of Norditropin Flexpro'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). | |||
| US9132239 | Dial-down mechanism for wind-up pen |
Feb, 2032
(7 years from now) | Active |
| US9457154 | Injection device with an end of dose feedback mechanism |
Sep, 2027
(2 years from now) | Active |
| US9687611 | Injection device with torsion spring and rotatable display |
Feb, 2027
(2 years from now) | Active |
| USRE46363 | Dial-down mechanism for wind-up pen |
Aug, 2026
(1 year, 7 months from now) | Active |
| US7686786 | Dial-down mechanism for wind-up pen |
Aug, 2026
(1 year, 7 months from now) | Active |
| US10220155 | Syringe device with a dose limiting mechanism and an additional safety mechanism |
Jul, 2026
(1 year, 6 months from now) | Active |
| US9775953 | Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left |
Jul, 2026
(1 year, 6 months from now) | Active |
| US8920383 | Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left |
Jul, 2026
(1 year, 6 months from now) | Active |
| US10376652 | Automatic injection device with a top release mechanism |
Jan, 2026
(1 year, 1 month from now) | Active |
| US10357616 | Injection device with an end of dose feedback mechanism |
Jan, 2026
(1 year, 1 month from now) | Active |
| US9108002 | Automatic injection device with a top release mechanism |
Jan, 2026
(1 year, 1 month from now) | Active |
| US9861757 | Injection device with an end of dose feedback mechanism |
Jan, 2026
(1 year, 1 month from now) | Active |
| US9616180 | Automatic injection device with a top release mechanism |
Jan, 2026
(1 year, 1 month from now) | Active |
| US8684969 | Injection device with torsion spring and rotatable display |
Oct, 2025
(10 months from now) | Active |
| US7762994 | Needle mounting system and a method for mounting a needle assembly |
May, 2024
(6 months ago) |
Expired
|
| US8579869 | Needle mounting system and a method for mounting a needle assembly |
Jun, 2023
(1 year, 5 months ago) |
Expired
|
| US8672898 | Automatic injection device with reset feature |
Jan, 2022
(2 years ago) |
Expired
|
| US6899699 | Automatic injection device with reset feature |
Jan, 2022
(2 years ago) |
Expired
|
| US9486588 | Automatic injection device with reset feature |
Jan, 2022
(2 years ago) |
Expired
|
| US6716198 | Injection device |
Jun, 2021
(3 years ago) |
Expired
|
| US8841252 | Pharmaceutical formulation |
Dec, 2017
(6 years ago) |
Expired
|
| US5849704 | Pharmaceutical formulation |
Dec, 2015
(9 years ago) |
Expired
|
| US5849700 | Pharmaceutical formulation |
Dec, 2015
(9 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 Norditropin Flexpro's patents.
Latest Legal Activities on Norditropin Flexpro's Patents
Given below is the list of recent legal activities going on the following patents of Norditropin Flexpro.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Maintenance Fee Reminder Mailed Critical | 01 Jul, 2024 | US9486588 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Mar, 2024 | US9457154 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Feb, 2023 | US9132239 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Jan, 2023 | US9108002 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 21 Jan, 2023 | US10376652 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 21 Dec, 2022 | US10357616 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 19 Aug, 2022 | US10220155 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 19 May, 2022 | US8920383 |
| Expire Patent Critical | 02 May, 2022 | US7686786 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 16 Dec, 2021 | US7762994 |
FDA has granted several exclusivities to Norditropin Flexpro. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Norditropin Flexpro, 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 Flexpro.
Exclusivity Information
Norditropin Flexpro holds 2 exclusivities. All of its exclusivities have expired in 2014. Details of Norditropin Flexpro'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 |
Several oppositions have been filed on Norditropin Flexpro's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Norditropin Flexpro's generic, the next section provides detailed information on ongoing and past EP oppositions related to Norditropin Flexpro patents.
Norditropin Flexpro's Oppositions Filed in EPO
Norditropin Flexpro has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Feb 23, 2006, by Owen Mumford Limited. This opposition was filed on patent number EP02726984A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP02726984A | NA | Genentech, Inc. | Patent maintained as amended |
| EP06701034A | Jan, 2018 | Schwöbel, Thilo | Opposition rejected |
| EP06754730A | Dec, 2011 | Ypsomed AG | Patent maintained as amended |
| EP06754730A | Nov, 2011 | WMC Matthes Consulting | Patent maintained as amended |
| EP06762643A | Jul, 2010 | Sanofi-Aventis Deutschland GmbH | Patent maintained as amended |
| EP05796880A | Jul, 2010 | Stöckeler, Ferdinand | Granted and Under Opposition |
| EP05796880A | Jul, 2010 | Ypsomed AG | Granted and Under Opposition |
| EP05796880A | Jul, 2010 | Ferring International Center S.A. | Granted and Under Opposition |
| EP05796880A | Jul, 2010 | OWEN MUMFORD LIMITED | Granted and Under Opposition |
| EP05796880A | Jul, 2010 | Genentech, Inc. | Granted and Under Opposition |
| EP05796880A | Jul, 2010 | COPERNICUS sp. zo.o. | Granted and Under Opposition |
| EP06121820A | May, 2010 | SANOFI-AVENTIS DEUTSCHLAND GMBH | Opposition rejected |
| EP02726984A | Mar, 2006 | TecPharma Licensing AG | Patent maintained as amended |
| EP02726984A | Feb, 2006 | OWEN MUMFORD LIMITED | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Norditropin Flexpro 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 Flexpro's family patents as well as insights into ongoing legal events on those patents.
Norditropin Flexpro's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Norditropin Flexpro's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 01, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Norditropin Flexpro Generics:
There are no approved generic versions for Norditropin Flexpro as of now.
About Norditropin Flexpro
Norditropin Flexpro is a drug owned by Novo Nordisk Inc. It is used for treating disorders related to growth hormone deficiency. Norditropin Flexpro uses Somatropin Recombinant as an active ingredient. Norditropin Flexpro was launched by Novo Nordisk Inc in 2015.
Approval Date:
Norditropin Flexpro was approved by FDA for market use on 23 January, 2015.
Active Ingredient:
Norditropin Flexpro uses Somatropin Recombinant as the active ingredient. Check out other Drugs and Companies using Somatropin Recombinant ingredient
Treatment:
Norditropin Flexpro is used for treating disorders related to growth hormone deficiency.
Dosage:
Norditropin Flexpro 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 | Prescription | INJECTION |
| 5MG/1.5ML | INJECTABLE | Prescription | INJECTION |
| 10MG/1.5ML | INJECTABLE | Prescription | INJECTION |
Norditropin Flexpro is a drug owned by Novo Nordisk Inc. It is protected by 22 US drug patents filed from 2015 to 2019. Out of these, 14 drug patents are active and 8 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 01, 2032. Details of Norditropin Flexpro's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US5849704 | Pharmaceutical formulation |
Dec, 2015
(9 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9132239 | Dial-down mechanism for wind-up pen |
Feb, 2032
(7 years from now) | Active |
| US9457154 | Injection device with an end of dose feedback mechanism |
Sep, 2027
(2 years from now) | Active |
| US9687611 | Injection device with torsion spring and rotatable display |
Feb, 2027
(2 years from now) | Active |
| USRE46363 | Dial-down mechanism for wind-up pen |
Aug, 2026
(1 year, 7 months from now) | Active |
| US7686786 | Dial-down mechanism for wind-up pen |
Aug, 2026
(1 year, 7 months from now) | Active |
| US9775953 | Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left |
Jul, 2026
(1 year, 6 months from now) | Active |
| US10220155 | Syringe device with a dose limiting mechanism and an additional safety mechanism |
Jul, 2026
(1 year, 6 months from now) | Active |
| US8920383 | Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left |
Jul, 2026
(1 year, 6 months from now) | Active |
| US10376652 | Automatic injection device with a top release mechanism |
Jan, 2026
(1 year, 1 month from now) | Active |
| US9861757 | Injection device with an end of dose feedback mechanism |
Jan, 2026
(1 year, 1 month from now) | Active |
| US9616180 | Automatic injection device with a top release mechanism |
Jan, 2026
(1 year, 1 month from now) | Active |
| US10357616 | Injection device with an end of dose feedback mechanism |
Jan, 2026
(1 year, 1 month from now) | Active |
| US9108002 | Automatic injection device with a top release mechanism |
Jan, 2026
(1 year, 1 month from now) | Active |
| US8684969 | Injection device with torsion spring and rotatable display |
Oct, 2025
(10 months from now) | Active |
| US7762994 | Needle mounting system and a method for mounting a needle assembly |
May, 2024
(6 months ago) |
Expired
|
| US8579869 | Needle mounting system and a method for mounting a needle assembly |
Jun, 2023
(1 year, 5 months ago) |
Expired
|
| US8672898 | Automatic injection device with reset feature |
Jan, 2022
(2 years ago) |
Expired
|
| US9486588 | Automatic injection device with reset feature |
Jan, 2022
(2 years ago) |
Expired
|
| US6899699 | Automatic injection device with reset feature |
Jan, 2022
(2 years ago) |
Expired
|
| US8841252 | Pharmaceutical formulation |
Dec, 2017
(6 years ago) |
Expired
|
| US5849700 | Pharmaceutical formulation |
Dec, 2015
(9 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 Norditropin Flexpro's patents.
Latest Legal Activities on Norditropin Flexpro's Patents
Given below is the list of recent legal activities going on the following patents of Norditropin Flexpro.
| Activity | Date | Patent Number |
|---|---|---|
| | ||
| Maintenance Fee Reminder Mailed Critical | 01 Jul, 2024 | US9486588 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Mar, 2024 | US9457154 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Feb, 2023 | US9132239 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Jan, 2023 | US9108002 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 21 Jan, 2023 | US10376652 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 21 Dec, 2022 | US10357616 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 19 Aug, 2022 | US10220155 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 19 May, 2022 | US8920383 |
| Expire Patent Critical | 02 May, 2022 | US7686786 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 16 Dec, 2021 | US7762994 |
FDA has granted several exclusivities to Norditropin Flexpro. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Norditropin Flexpro, 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 Flexpro.
Exclusivity Information
Norditropin Flexpro holds 2 exclusivities. All of its exclusivities have expired in 2014. Details of Norditropin Flexpro'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 |
Several oppositions have been filed on Norditropin Flexpro's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Norditropin Flexpro's generic, the next section provides detailed information on ongoing and past EP oppositions related to Norditropin Flexpro patents.
Norditropin Flexpro's Oppositions Filed in EPO
Norditropin Flexpro has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Feb 23, 2006, by Owen Mumford Limited. This opposition was filed on patent number EP02726984A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP02726984A | NA | Genentech, Inc. | Patent maintained as amended |
| EP06701034A | Jan, 2018 | Schwöbel, Thilo | Opposition rejected |
| EP06754730A | Dec, 2011 | Ypsomed AG | Patent maintained as amended |
| EP06754730A | Nov, 2011 | WMC Matthes Consulting | Patent maintained as amended |
| EP06762643A | Jul, 2010 | Sanofi-Aventis Deutschland GmbH | Patent maintained as amended |
| EP05796880A | Jul, 2010 | Stöckeler, Ferdinand | Granted and Under Opposition |
| EP05796880A | Jul, 2010 | Ypsomed AG | Granted and Under Opposition |
| EP05796880A | Jul, 2010 | Ferring International Center S.A. | Granted and Under Opposition |
| EP05796880A | Jul, 2010 | OWEN MUMFORD LIMITED | Granted and Under Opposition |
| EP05796880A | Jul, 2010 | Genentech, Inc. | Granted and Under Opposition |
| EP05796880A | Jul, 2010 | COPERNICUS sp. zo.o. | Granted and Under Opposition |
| EP06121820A | May, 2010 | SANOFI-AVENTIS DEUTSCHLAND GMBH | Opposition rejected |
| EP02726984A | Mar, 2006 | TecPharma Licensing AG | Patent maintained as amended |
| EP02726984A | Feb, 2006 | OWEN MUMFORD LIMITED | Patent maintained as amended |
US patents provide insights into the exclusivity only within the United States, but Norditropin Flexpro 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 Flexpro's family patents as well as insights into ongoing legal events on those patents.
Norditropin Flexpro's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Norditropin Flexpro's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 01, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Norditropin Flexpro Generics:
There are no approved generic versions for Norditropin Flexpro as of now.
About Norditropin Flexpro
Norditropin Flexpro is a drug owned by Novo Nordisk Inc. It is used for treating disorders related to growth hormone deficiency. Norditropin Flexpro uses Somatropin as an active ingredient. Norditropin Flexpro was launched by Novo Nordisk Inc in 2015.
Approval Date:
Norditropin Flexpro was approved by FDA for market use on 23 January, 2015.
Active Ingredient:
Norditropin Flexpro uses Somatropin as the active ingredient. Check out other Drugs and Companies using Somatropin ingredient
Treatment:
Norditropin Flexpro is used for treating disorders related to growth hormone deficiency.
Dosage:
Norditropin Flexpro is available in injectable form for injection use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 30MG/3ML | INJECTABLE | Prescription | INJECTION |