Valchlor is a drug owned by Helsinn Birex Pharmaceuticals Ltd. It is protected by 6 US drug patents filed from 2013 to 2016 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 08, 2029. Details of Valchlor'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). | |||
| US7872050 | Stabilized compositions of volatile alkylating agents and methods of using thereof |
Jul, 2029
(4 years from now) | Active |
| US8450375 | Stabilized compositions of volatile alkylating agents and methods of using thereof |
Mar, 2026
(1 year, 3 months from now) | Active |
| US8501818 | Stabilized compositions of alkylating agents and methods of using same |
Mar, 2026
(1 year, 3 months from now) | Active |
| US7838564 | Stabilized compositions of volatile alkylating agents and methods of using thereof |
Mar, 2026
(1 year, 3 months from now) | Active |
| US9382191 | Stabilized compositions of volatile alkylating agents and methods of using thereof |
Mar, 2026
(1 year, 3 months from now) | Active |
| US8501819 | Stabilized compositions of volatile alkylating agents and methods of using thereof |
Mar, 2026
(1 year, 3 months 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 Valchlor's patents.
Latest Legal Activities on Valchlor's Patents
Given below is the list of recent legal activities going on the following patents of Valchlor.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 22 Jun, 2022 | US7872050 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 21 Apr, 2022 | US7838564 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Jan, 2021 | US8501818 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Jan, 2021 | US8501819 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Oct, 2020 | US8450375 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 10 Jul, 2018 | US7872050 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 15 May, 2018 | US7838564 |
| Change in Power of Attorney (May Include Associate POA) Critical | 01 Feb, 2017 | US7872050 |
| Email Notification Critical | 01 Feb, 2017 | US7872050 |
| Correspondence Address Change Critical | 30 Jan, 2017 | US7872050 |
FDA has granted several exclusivities to Valchlor. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Valchlor, 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 Valchlor.
Exclusivity Information
Valchlor holds 3 exclusivities. All of its exclusivities have expired in 2020. Details of Valchlor's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Aug 23, 2016 |
| Orphan Drug Exclusivity(ODE) | Aug 23, 2020 |
| Orphan Drug Exclusivity(ODE-51) | Aug 23, 2020 |
US patents provide insights into the exclusivity only within the United States, but Valchlor 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 Valchlor's family patents as well as insights into ongoing legal events on those patents.
Valchlor's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Valchlor's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 08, 2029 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Valchlor Generics:
There are no approved generic versions for Valchlor as of now.
About Valchlor
Valchlor is a drug owned by Helsinn Birex Pharmaceuticals Ltd. It is used for treating stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy. Valchlor uses Mechlorethamine Hydrochloride as an active ingredient. Valchlor was launched by Helsinn in 2013.
Approval Date:
Valchlor was approved by FDA for market use on 23 August, 2013.
Active Ingredient:
Valchlor uses Mechlorethamine Hydrochloride as the active ingredient. Check out other Drugs and Companies using Mechlorethamine Hydrochloride ingredient
Treatment:
Valchlor is used for treating stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin-directed therapy.
Dosage:
Valchlor is available in gel form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.016% BASE | GEL | Prescription | TOPICAL |