Oforta is a drug owned by Sanofi Aventis Us Llc. It is protected by 2 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 20, 2022. Details of Oforta'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US7547776 | Process for the production of fludarabine-phosphate lithium, sodium, potassium, calcium and magnesium salts and purification process for the production of fludarabine-phosphate and fludarabine-phosphate with a purity of at least 99.5% |
Dec, 2018
(5 years ago) |
Expired
|
| US7148207 | Oral fludara of high-purity formulation with quick release of active ingredient |
Dec, 2022
(1 year, 7 months 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 Oforta's patents.
Latest Legal Activities on Oforta's Patents
Given below is the list of recent legal activities going on the following patents of Oforta.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Post Issue Communication - Certificate of Correction | 03 Dec, 2019 | US7148207 |
| Expire Patent | 09 Jan, 2015 | US7148207 |
| Recordation of Patent Grant Mailed | 12 Dec, 2006 | US7148207 |
| Patent Issue Date Used in PTA Calculation | 12 Dec, 2006 | US7148207 |
| Issue Notification Mailed | 22 Nov, 2006 | US7148207 |
| Dispatch to FDC | 06 Nov, 2006 | US7148207 |
| Application Is Considered Ready for Issue | 02 Jun, 2006 | US7148207 |
| Issue Fee Payment Verified | 26 May, 2006 | US7148207 |
| Issue Fee Payment Received | 26 May, 2006 | US7148207 |
| Mail Notice of Allowance | 28 Apr, 2006 | US7148207 |
FDA has granted several exclusivities to Oforta. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Oforta, 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 Oforta.
Exclusivity Information
Oforta holds 2 exclusivities. All of its exclusivities have expired in 2015. Details of Oforta's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Dec 18, 2011 |
| Orphan Drug Exclusivity(ODE) | Dec 18, 2015 |
US patents provide insights into the exclusivity only within the United States, but Oforta 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 Oforta's family patents as well as insights into ongoing legal events on those patents.
Oforta's family patents
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Generic Launch
Generic Release Date:
Oforta's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 20, 2022 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Oforta Generics:
Fludarabine Phosphate is the generic name for the brand Oforta. 9 different companies have already filed for the generic of Oforta, with Fresenius Kabi Usa having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Oforta's generic
About Oforta
Oforta is a drug owned by Sanofi Aventis Us Llc. It is used for treating patients with B-cell chronic lymphocytic leukemia (CLL). Oforta uses Fludarabine Phosphate as an active ingredient. Oforta was launched by Sanofi Aventis Us in 2008.
Market Authorisation Date:
Oforta was approved by FDA for market use on 18 December, 2008.
Active Ingredient:
Oforta uses Fludarabine Phosphate as the active ingredient. Check out other Drugs and Companies using Fludarabine Phosphate ingredient
Treatment:
Oforta is used for treating patients with B-cell chronic lymphocytic leukemia (CLL).
Dosage:
Oforta is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 10MG | TABLET | Discontinued | ORAL |