Differin is a drug owned by Galderma Laboratories Lp. It is protected by 9 US drug patents filed from 2013 to 2014. Out of these, 4 drug patents are active and 5 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be May 31, 2028. Details of Differin'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). | |||
| US7998467 | Cosmetic/dermatological compositions comprising naphthoic acid compounds and polyurethane polymers |
May, 2028
(3 years from now) | Active |
| US8435502 | Cosmetic/dermatological compositions comprising naphtholic acid compounds and polyurethane polymers |
Sep, 2026
(1 year, 8 months from now) | Active |
| US8709392 | Cosmetic/dermatological compositions comprising naphthoic acid compounds and polyurethane polymers |
Sep, 2026
(1 year, 8 months from now) | Active |
| US7579377 | Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders |
Feb, 2025
(2 months from now) | Active |
| US7737181 | Pharmaceutical compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders |
Aug, 2024
(3 months ago) |
Expired
|
| US7838558 | Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders |
Mar, 2023
(1 year, 9 months ago) |
Expired
|
| US7834060 | Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphtoic acid for the treatment of dermatological disorders |
Mar, 2023
(1 year, 9 months ago) |
Expired
|
| US8703820 | Administration of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid for the treatment of dermatological disorders |
Mar, 2023
(1 year, 9 months ago) |
Expired
|
| US7868044 | Method for the treatment of acne using compositions comprising 0.3% by weight of 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid |
Mar, 2023
(1 year, 9 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 Differin's patents.
Latest Legal Activities on Differin's Patents
Given below is the list of recent legal activities going on the following patents of Differin.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 13 Feb, 2023 | US7868044 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 08 Feb, 2023 | US7998467 |
| Expire Patent Critical | 26 Dec, 2022 | US7838558 |
| Expire Patent Critical | 19 Dec, 2022 | US7834060 |
| Maintenance Fee Reminder Mailed Critical | 29 Aug, 2022 | US7868044 |
| Expire Patent Critical | 18 Jul, 2022 | US7737181 |
| Maintenance Fee Reminder Mailed Critical | 11 Jul, 2022 | US7838558 |
| Maintenance Fee Reminder Mailed Critical | 04 Jul, 2022 | US7834060 |
| Maintenance Fee Reminder Mailed Critical | 31 Jan, 2022 | US7737181 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 10 Feb, 2021 | US7579377 (Litigated) |
FDA has granted several exclusivities to Differin. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Differin, 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 Differin.
Exclusivity Information
Differin holds 2 exclusivities. All of its exclusivities have expired in 2019. Details of Differin's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Mar 17, 2013 |
| RTO(RTO) | Jul 08, 2019 |
US patents provide insights into the exclusivity only within the United States, but Differin 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 Differin's family patents as well as insights into ongoing legal events on those patents.
Differin's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Differin's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be May 31, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Differin Generic API suppliers:
Adapalene is the generic name for the brand Differin. 9 different companies have already filed for the generic of Differin, with Call Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Differin's generic
How can I launch a generic of Differin before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Differin's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Differin'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 Differin -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.003 | 15 Sep, 2009 | 1 | 14 Jun, 2012 | 23 Feb, 2025 | Eligible |
Alternative Brands for Differin
Differin which is used for treating acne vulgaris., has several other brand drugs in the same treatment category and using the same active ingredient (Adapalene). 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 | Treatment Area | ||||
|---|---|---|---|---|---|---|
| Bausch |
| |||||
| Galderma Labs |
| |||||
| Galderma Labs Lp |
| |||||
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Adapalene. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Bausch |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Adapalene, Differin's active ingredient. Check the complete list of approved generic manufacturers for Differin
About Differin
Differin is a drug owned by Galderma Laboratories Lp. It is used for treating acne vulgaris. Differin uses Adapalene as an active ingredient. Differin was launched by Galderma Labs Lp in 2010.
Approval Date:
Differin was approved by FDA for market use on 17 March, 2010.
Active Ingredient:
Differin uses Adapalene as the active ingredient. Check out other Drugs and Companies using Adapalene ingredient
Treatment:
Differin is used for treating acne vulgaris.
Dosage:
Differin is available in the following dosage forms - gel form for topical use, lotion form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.1% | LOTION | Discontinued | TOPICAL |
| 0.3% | GEL | Prescription | TOPICAL |