Caprelsa is a drug owned by Genzyme Corp. It is protected by 4 US drug patents filed from 2013 to 2014. Out of these, 1 drug patents are active and 3 have expired. Caprelsa's patents have been open to challenges since 07 April, 2015. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 08, 2028. Details of Caprelsa'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). | |||
| US8067427 | Pharmaceutical compositions comprising ZD6474 |
Aug, 2028
(3 years from now) | Active |
| US8642608 | Quinazoline derivatives as VEGF inhibitors |
Feb, 2022
(2 years ago) |
Expired
|
| US7173038 | Quinazoline derivatives as VEGF inhibitors |
Aug, 2021
(3 years ago) |
Expired
|
| USRE42353 | Quinazoline derivatives and pharmaceutical compositions containing them |
Sep, 2017
(7 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 Caprelsa's patents.
Latest Legal Activities on Caprelsa's Patents
Given below is the list of recent legal activities going on the following patents of Caprelsa.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 17 May, 2023 | US8067427 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Jul, 2021 | US8642608 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 16 May, 2019 | US8067427 |
| 11.5 yr surcharge- late pmt w/in 6 mo, Large Entity | 20 Dec, 2018 | US7173038 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 20 Dec, 2018 | US7173038 |
| Maintenance Fee Reminder Mailed Critical | 24 Sep, 2018 | US7173038 |
| Correspondence Address Change Critical | 11 Oct, 2017 | US7173038 |
| Electronic Review Critical | 10 Oct, 2017 | US7173038 |
| Email Notification Critical | 10 Oct, 2017 | US7173038 |
| Mail Pre-Exam Notice | 10 Oct, 2017 | US7173038 |
FDA has granted several exclusivities to Caprelsa. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Caprelsa, 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 Caprelsa.
Exclusivity Information
Caprelsa holds 3 exclusivities. All of its exclusivities have expired in 2018. Details of Caprelsa's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Apr 06, 2016 |
| Orphan Drug Exclusivity(ODE) | Apr 06, 2018 |
| Orphan Drug Exclusivity(ODE-9) | Apr 06, 2018 |
US patents provide insights into the exclusivity only within the United States, but Caprelsa 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 Caprelsa's family patents as well as insights into ongoing legal events on those patents.
Caprelsa's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Caprelsa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 08, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Caprelsa Generics:
There are no approved generic versions for Caprelsa as of now.
About Caprelsa
Caprelsa is a drug owned by Genzyme Corp. It is used for treating symptomatic or progressive medullary thyroid cancer that is unresectable locally advanced or metastatic. Caprelsa uses Vandetanib as an active ingredient. Caprelsa was launched by Genzyme Corp in 2011.
Approval Date:
Caprelsa was approved by FDA for market use on 06 April, 2011.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Caprelsa is 06 April, 2011, its NCE-1 date is estimated to be 07 April, 2015.
Active Ingredient:
Caprelsa uses Vandetanib as the active ingredient. Check out other Drugs and Companies using Vandetanib ingredient
Treatment:
Caprelsa is used for treating symptomatic or progressive medullary thyroid cancer that is unresectable locally advanced or metastatic.
Dosage:
Caprelsa is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG | TABLET | Prescription | ORAL |
| 300MG | TABLET | Prescription | ORAL |