Altabax is a drug owned by Almirall Llc. It is protected by 4 US drug patents filed from 2013 to 2016. Out of these, 2 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 14, 2027. Details of Altabax's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protects the active chemical substance. Only drug patent owner can launch products that use this active substance. | |||
| US7875630 | Process salts compositions and use |
Feb, 2027
(2 years from now) | Active |
| These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| USRE43390 | Pleuromutilin derivatives as antimicrobials |
Apr, 2021
(3 years ago) |
Expired
|
| USRE39128 | Pleuromutilin derivatives as antimicrobials |
Apr, 2021
(3 years ago) |
Expired
|
| US8207191 | Process, salts, composition and use |
Aug, 2024
(a month from now) | Active |
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 Altabax's patents.
Latest Legal Activities on Altabax's Patents
Given below is the list of recent legal activities going on the following patents of Altabax.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 26 Dec, 2023 | US8207191 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 25 Jul, 2022 | US7875630 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 26 Dec, 2019 | US8207191 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 25 Jul, 2018 | US7875630 |
| Recordation of Patent Grant Mailed | 26 Jun, 2012 | US8207191 |
| Patent Issue Date Used in PTA Calculation | 26 Jun, 2012 | US8207191 |
| Issue Notification Mailed | 06 Jun, 2012 | US8207191 |
| Dispatch to FDC | 29 May, 2012 | US8207191 |
| Mail Miscellaneous Communication to Applicant | 25 May, 2012 | US8207191 |
| Printer Rush- No mailing | 25 May, 2012 | US8207191 |
FDA has granted several exclusivities to Altabax. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Altabax, 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 Altabax.
Exclusivity Information
Altabax holds 1 exclusivities. All of its exclusivities have expired in 2012. Details of Altabax's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Apr 12, 2012 |
US patents provide insights into the exclusivity only within the United States, but Altabax 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 Altabax's family patents as well as insights into ongoing legal events on those patents.
Altabax's family patents
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Generic Launch
Generic Release Date:
Altabax's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 14, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Altabax Generics:
There are no approved generic versions for Altabax as of now.
About Altabax
Altabax is a drug owned by Almirall Llc. It is used for treating impetigo caused by Staphylococcus aureus or Streptococcus pyogenes. Altabax uses Retapamulin as an active ingredient. Altabax was launched by Almirall in 2007.
Market Authorisation Date:
Altabax was approved by FDA for market use on 12 April, 2007.
NCE-1 date:
NCE-1 date is also known as the four year date as it is four years after the original drug approval. Since the approval date for Altabax is 12 April, 2007, its NCE-1 date is estimated to be 13 April, 2011
Active Ingredient:
Altabax uses Retapamulin as the active ingredient. Check out other Drugs and Companies using Retapamulin ingredient
Treatment:
Altabax is used for treating impetigo caused by Staphylococcus aureus or Streptococcus pyogenes.
Dosage:
Altabax is available in ointment form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1% | OINTMENT | Discontinued | TOPICAL |