Absorica is a drug owned by Sun Pharmaceutical Industries Inc. It is protected by 5 US drug patents filed from 2013 to 2015 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 21, 2021. Details of Absorica'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). | |||
| US8952064 | Pharmaceutical semi-solid composition of isotretinoin |
Sep, 2021
(3 years ago) |
Expired
|
| US9089534 | Pharmaceutical semi-solid composition of isotretinoin |
Sep, 2021
(3 years ago) |
Expired
|
| US8367102 | Pharmaceutical semi-solid composition of isotretinoin |
Sep, 2021
(3 years ago) |
Expired
|
| US9078925 | Pharmaceutical semi-solid composition of isotretinoin |
Sep, 2021
(3 years ago) |
Expired
|
| US7435427 | Pharmaceutical semi-solid composition of isotretinoin |
Sep, 2021
(3 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 Absorica's patents.
Latest Legal Activities on Absorica's Patents
Given below is the list of recent legal activities going on the following patents of Absorica.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 08 Feb, 2024 | US8367102 (Litigated) |
| Correspondence Address Change Critical | 20 Sep, 2023 | US7435427 (Litigated) |
| Payment of Maintenance Fee, 8th Year, Large Entity | 28 Jul, 2022 | US9089534 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 10 Feb, 2022 | US8952064 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 06 Feb, 2020 | US8367102 (Litigated) |
| Payment of Maintenance Fee, 12th Year, Large Entity | 14 Oct, 2019 | US7435427 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 31 Jul, 2018 | US9089534 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 12 Feb, 2018 | US8952064 |
| Post Issue Communication - Certificate of Correction | 27 Apr, 2016 | US8367102 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 28 Jul, 2015 | US9089534 |
FDA has granted several exclusivities to Absorica. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Absorica, 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 Absorica.
Exclusivity Information
Absorica holds 1 exclusivities. All of its exclusivities have expired in 2015. Details of Absorica's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | May 25, 2015 |
US patents provide insights into the exclusivity only within the United States, but Absorica 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 Absorica's family patents as well as insights into ongoing legal events on those patents.
Absorica's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Absorica's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 21, 2021 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Absorica Generic API suppliers:
Isotretinoin is the generic name for the brand Absorica. 9 different companies have already filed for the generic of Absorica, with Upsher Smith Labs having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Absorica's generic
How can I launch a generic of Absorica before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Absorica's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Absorica's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Absorica -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 30 mg | 31 Dec, 2012 | 1 | 31 Mar, 2021 | 21 Sep, 2021 | Eligible Deferred |
| 40 mg | 31 Dec, 2012 | 1 | 31 Mar, 2021 | 21 Sep, 2021 | Extinguished Deferred |
| 20 mg | 07 Jan, 2013 | 1 | 31 Mar, 2021 | 21 Sep, 2021 | Eligible Deferred |
| 10 mg | 20 Jun, 2013 | 1 | 31 Mar, 2021 | 21 Sep, 2021 | Eligible Deferred |
| 35 mg | 25 Nov, 2015 | 1 | 31 Mar, 2021 | 21 Sep, 2021 | Deferred |
| 25 mg | 16 May, 2016 | 1 | 31 Mar, 2021 | 21 Sep, 2021 | Deferred |
Alternative Brands for Absorica
Absorica which is used for treating skin disorders., has several other brand drugs using the same active ingredient (Isotretinoin). 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 | |
|---|---|---|
| Sun Pharm |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Isotretinoin, Absorica's active ingredient. Check the complete list of approved generic manufacturers for Absorica
About Absorica
Absorica is a drug owned by Sun Pharmaceutical Industries Inc. It is used for treating skin disorders. Absorica uses Isotretinoin as an active ingredient. Absorica was launched by Sun Pharm Inds Inc in 2012.
Approval Date:
Absorica was approved by FDA for market use on 25 May, 2012.
Active Ingredient:
Absorica uses Isotretinoin as the active ingredient. Check out other Drugs and Companies using Isotretinoin ingredient
Treatment:
Absorica is used for treating skin disorders.
Dosage:
Absorica is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 20MG | CAPSULE | Prescription | ORAL |
| 40MG | CAPSULE | Prescription | ORAL |
| 35MG | CAPSULE | Prescription | ORAL |
| 10MG | CAPSULE | Prescription | ORAL |
| 30MG | CAPSULE | Prescription | ORAL |
| 25MG | CAPSULE | Prescription | ORAL |