Gonal-f is a drug owned by Emd Serono 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 Aug 23, 2019. Details of Gonal-f'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). | |||
| US7563763 | FSH and FSH variant formulations, products and methods |
Aug, 2019
(6 years ago) |
Expired
|
| US5767251 | Recombinant heterodimeric human fertility hormones, and methods, cells, and vectors and DNA for the production thereof |
Jun, 2015
(10 years ago) |
Expired
|
| US5767067 | Follicle stimulating hormone and pharmaceutical compositions containing same |
Jun, 2015
(10 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 Gonal-f's patents.
Latest Legal Activities on Gonal-f's Patents
Given below is the list of recent legal activities going on the following patents of Gonal-f.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent
Critical | 23 Aug, 2021 | US7563763 |
| Maintenance Fee Reminder Mailed
Critical | 08 Mar, 2021 | US7563763 |
| Post Issue Communication - Certificate of Correction | 31 Jul, 2009 | US7563763 |
| Sequence Moved to Public Database | 30 Jul, 2009 | US7563763 |
| Patent Issue Date Used in PTA Calculation
Critical | 21 Jul, 2009 | US7563763 |
| Recordation of Patent Grant Mailed
Critical | 21 Jul, 2009 | US7563763 |
| Issue Notification Mailed
Critical | 01 Jul, 2009 | US7563763 |
| Dispatch to FDC | 16 Jun, 2009 | US7563763 |
| Mail Response to 312 Amendment (PTO-271)
Critical | 16 Jun, 2009 | US7563763 |
| Filing Receipt - Corrected | 15 Jun, 2009 | US7563763 |
US patents provide insights into the exclusivity only within the United States, but
Gonal-f 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 Gonal-f's family patents as well as insights into
ongoing legal events
on those patents.
Gonal-f's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Gonal-f's generic launch date based on the expiry of its last outstanding patent is estimated to be Aug 23, 2019 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Gonal-f Generics:
There are no approved generic versions for Gonal-f as of now.
Alternative Brands for Gonal-f
There are several other brand drugs using the same active ingredient (Follitropin Alfa/beta) as Gonal-f. 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 | ||
|---|---|---|---|
| Emd Serono |
| ||
| Organon Usa Inc |
|
About Gonal-f
Gonal-F is a drug owned by Emd Serono Inc. Gonal-F uses Follitropin Alfa/Beta as an active ingredient. Gonal-F was launched by Emd Serono in 2001.
Approval Date:
Gonal-f was approved by FDA for market use on 28 February, 2001.
Active Ingredient:
Gonal-f uses Follitropin Alfa/beta as the active ingredient. Check out other Drugs and Companies using Follitropin Alfa/beta ingredient
Dosage:
Gonal-f is available in injectable form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 450 IU/VIAL | INJECTABLE | Prescription | SUBCUTANEOUS |
| 1,050 IU/VIAL | INJECTABLE | Prescription | SUBCUTANEOUS |
| 150 IU/VIAL | INJECTABLE | Discontinued | SUBCUTANEOUS |
| 75 IU/VIAL | INJECTABLE | Discontinued | SUBCUTANEOUS |
| 37.5 IU/VIAL | INJECTABLE | Discontinued | SUBCUTANEOUS |