Egrifta is a drug owned by Emd Serono Inc. It is protected by 6 US drug patents filed from 2013 to 2018 out of which all have expired. Egrifta's patents have been open to challenges since 10 November, 2014. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 14, 2023. Details of Egrifta'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). | |||
| US8314066 | GH secretagogues and uses thereof |
Aug, 2023
(1 year, 4 months ago) |
Expired
|
| US8435945 | GH secretagogues and uses thereof |
Aug, 2023
(1 year, 4 months ago) |
Expired
|
| US7316997 | GH secretagogues and uses thereof |
Aug, 2023
(1 year, 4 months ago) |
Expired
|
| US7144577 | Treatment of HIV-associated dysmorphia/dysmetabolic syndrome (HADDS) with or without lipodystrophy |
Jul, 2020
(4 years ago) |
Expired
|
| US6020311 | GRF analogs with increased biological potency |
May, 2015
(9 years ago) |
Expired
|
| US5861379 | Chimeric fatty body-pro-GRF analogs with increased biological potency |
May, 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 Egrifta's patents.
Latest Legal Activities on Egrifta's Patents
Given below is the list of recent legal activities going on the following patents of Egrifta.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Maintenance Fee Reminder Mailed Critical | 08 Jul, 2024 | US8314066 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Oct, 2020 | US8435945 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 18 May, 2020 | US8314066 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 24 Jun, 2019 | US7316997 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 24 May, 2018 | US7144577 |
| Sequence Moved to Public Database | 09 May, 2013 | US8435945 |
| Recordation of Patent Grant Mailed Critical | 07 May, 2013 | US8435945 |
| Patent Issue Date Used in PTA Calculation Critical | 07 May, 2013 | US8435945 |
| Email Notification Critical | 18 Apr, 2013 | US8435945 |
| Issue Notification Mailed Critical | 17 Apr, 2013 | US8435945 |
FDA has granted several exclusivities to Egrifta. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Egrifta, 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 Egrifta.
Exclusivity Information
Egrifta holds 1 exclusivities. All of its exclusivities have expired in 2015. Details of Egrifta's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 10, 2015 |
US patents provide insights into the exclusivity only within the United States, but Egrifta 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 Egrifta's family patents as well as insights into ongoing legal events on those patents.
Egrifta's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Egrifta's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 14, 2023 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Egrifta Generics:
There are no approved generic versions for Egrifta as of now.
About Egrifta
Egrifta is a drug owned by Emd Serono Inc. It is used for reducing excess abdominal fat in HIV-infected patients with lipodystrophy. Egrifta uses Tesamorelin Acetate as an active ingredient. Egrifta was launched by Emd Serono in 2010.
Approval Date:
Egrifta was approved by FDA for market use on 10 November, 2010.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Egrifta is 10 November, 2010, its NCE-1 date is estimated to be 10 November, 2014.
Active Ingredient:
Egrifta uses Tesamorelin Acetate as the active ingredient. Check out other Drugs and Companies using Tesamorelin Acetate ingredient
Treatment:
Egrifta is used for reducing excess abdominal fat in HIV-infected patients with lipodystrophy.
Dosage:
Egrifta is available in powder form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 2MG BASE/VIAL | POWDER | Prescription | SUBCUTANEOUS |
| EQ 1MG BASE/VIAL | POWDER | Discontinued | SUBCUTANEOUS |