Follistim Aq is a drug owned by Organon Usa Inc. It is protected by 4 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 Follistim Aq'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
(5 years ago) |
Expired
|
| US7446090 | FSH formulation |
Aug, 2019
(5 years ago) |
Expired
|
| US5929028 | Liquid gonadotropin containing formulations |
Jan, 2018
(6 years ago) |
Expired
|
| US5767251 | Recombinant heterodimeric human fertility hormones, and methods, cells, and vectors and DNA for the production thereof |
Jun, 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 Follistim Aq's patents.
Latest Legal Activities on Follistim Aq's Patents
Given below is the list of recent legal activities going on the following patents of Follistim Aq.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 23 Aug, 2021 | US7563763 |
| Maintenance Fee Reminder Mailed Critical | 08 Mar, 2021 | US7563763 |
| Expire Patent Critical | 07 Dec, 2020 | US7446090 |
| Maintenance Fee Reminder Mailed Critical | 22 Jun, 2020 | US7446090 |
| Post Issue Communication - Certificate of Correction | 05 Aug, 2009 | US7446090 |
| Post Issue Communication - Certificate of Correction | 31 Jul, 2009 | US7563763 |
| Sequence Moved to Public Database | 30 Jul, 2009 | US7563763 |
| Recordation of Patent Grant Mailed Critical | 21 Jul, 2009 | US7563763 |
| Patent Issue Date Used in PTA Calculation Critical | 21 Jul, 2009 | US7563763 |
| Issue Notification Mailed Critical | 01 Jul, 2009 | US7563763 |
FDA has granted several exclusivities to Follistim Aq. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Follistim Aq, 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 Follistim Aq.
Exclusivity Information
Follistim Aq holds 2 exclusivities. All of its exclusivities have expired in 2014. Details of Follistim Aq's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-306) | Jun 28, 2013 |
| New Dosing Schedule(D-133) | Aug 22, 2014 |
US patents provide insights into the exclusivity only within the United States, but Follistim Aq 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 Follistim Aq's family patents as well as insights into ongoing legal events on those patents.
Follistim Aq's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Follistim Aq's generic launch date based on the last expiry date of its patents and exclusivities combined 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)
Follistim Aq Generics:
There are no approved generic versions for Follistim Aq as of now.
Alternative Brands for Follistim Aq
Follistim Aq which is used for inducing ovulation and treating infertility in both men and women., has several other brand drugs using the same active ingredient (Follitropin Alfa/beta). 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 Follistim Aq
Follistim Aq is a drug owned by Organon Usa Inc. It is used for inducing ovulation and treating infertility in both men and women. Follistim Aq uses Follitropin Alfa/Beta as an active ingredient. Follistim Aq was launched by Organon Usa Inc in 2004.
Approval Date:
Follistim Aq was approved by FDA for market use on 11 February, 2004.
Active Ingredient:
Follistim Aq uses Follitropin Alfa/beta as the active ingredient. Check out other Drugs and Companies using Follitropin Alfa/beta ingredient
Treatment:
Follistim Aq is used for inducing ovulation and treating infertility in both men and women.
Dosage:
Follistim Aq is available in injectable form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 300 IU/0.36ML | INJECTABLE | Prescription | SUBCUTANEOUS |
| 150 IU/0.18ML | INJECTABLE | Discontinued | SUBCUTANEOUS |
| 600 IU/0.72ML | INJECTABLE | Prescription | SUBCUTANEOUS |
| 900 IU/1.08ML | INJECTABLE | Prescription | SUBCUTANEOUS |
| 75 IU/0.5ML | INJECTABLE | Prescription | SUBCUTANEOUS |
| 150 IU/0.5ML | INJECTABLE | Prescription | SUBCUTANEOUS |