Velcade is a drug owned by Takeda Pharmaceuticals Usa Inc. It is protected by 11 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 Jul 25, 2022. Details of Velcade'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). | |||
|
US6958319 (Pediatric) | Formulation of boronic acid compounds |
Jul, 2022
(2 years ago) |
Expired
|
|
US6713446 (Pediatric) | Formulation of boronic acid compounds |
Jul, 2022
(2 years ago) |
Expired
|
| US6958319 | Formulation of boronic acid compounds |
Jan, 2022
(2 years ago) |
Expired
|
| US6713446 | Formulation of boronic acid compounds |
Jan, 2022
(2 years ago) |
Expired
|
|
US5780454 (Pediatric) | Boronic ester and acid compounds |
Nov, 2017
(7 years ago) |
Expired
|
| US5780454 | Boronic ester and acid compounds |
May, 2017
(7 years ago) |
Expired
|
| US6083903 | Boronic ester and acid compounds, synthesis and uses |
Oct, 2014
(10 years ago) |
Expired
|
| US6297217 | Boronic ester and acid compounds, synthesis and uses |
Oct, 2014
(10 years ago) |
Expired
|
| US6617317 | Boronic ester and acid compositions |
Oct, 2014
(10 years ago) |
Expired
|
| US7119080 | Boronic ester and acid compounds, synthesis and uses |
Oct, 2014
(10 years ago) |
Expired
|
| US6747150 | Boronic ester and acid compounds, synthesis and uses |
Oct, 2014
(10 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 Velcade's patents.
Latest Legal Activities on Velcade's Patents
Given below is the list of recent legal activities going on the following patents of Velcade.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Expire Patent Critical | 12 Nov, 2018 | US7119080 |
| Maintenance Fee Reminder Mailed Critical | 21 May, 2018 | US7119080 |
| Post Issue Communication - Certificate of Correction | 25 Jun, 2012 | US6958319 (Litigated) |
| Email Notification Critical | 18 Jun, 2012 | US6958319 (Litigated) |
| Mail Miscellaneous Communication to Applicant | 18 Jun, 2012 | US6958319 (Litigated) |
| Miscellaneous Communication to Applicant - No Action Count | 29 May, 2012 | US6958319 (Litigated) |
| Recordation of Patent Grant Mailed Critical | 10 Oct, 2006 | US7119080 |
| Patent Issue Date Used in PTA Calculation Critical | 10 Oct, 2006 | US7119080 |
| Issue Notification Mailed Critical | 20 Sep, 2006 | US7119080 |
| Printer Rush- No mailing | 05 Sep, 2006 | US7119080 |
FDA has granted several exclusivities to Velcade. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Velcade, 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 Velcade.
Exclusivity Information
Velcade holds 9 exclusivities. All of its exclusivities have expired in 2022. Details of Velcade's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| NR(NR) | Jan 23, 2015 |
| M(M-139) | Aug 08, 2017 |
| New Dosing Schedule(D-141) | Oct 08, 2017 |
| New Dosing Schedule(D-142) | Oct 08, 2017 |
| New Indication(I-695) | Oct 08, 2017 |
| M(M-165) | Sep 14, 2018 |
| Orphan Drug Exclusivity(ODE) | Oct 08, 2021 |
| Orphan Drug Exclusivity(ODE-76) | Oct 08, 2021 |
| Pediatric Exclusivity(PED) | Apr 08, 2022 |
Several oppositions have been filed on Velcade's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Velcade's generic, the next section provides detailed information on ongoing and past EP oppositions related to Velcade patents.
Velcade's Oppositions Filed in EPO
Velcade has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Dec 08, 2011, by Hameln Rds Gmbh. This opposition was filed on patent number EP02709145A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP16157001A | Aug, 2019 | Generics [UK] Ltd | Granted and Under Opposition |
| EP16157001A | Aug, 2019 | Dr. Reddy's Laboratories Limited | Granted and Under Opposition |
| EP16157001A | Aug, 2019 | KRKA, d.d., Novo mesto | Granted and Under Opposition |
| EP16157001A | Aug, 2019 | Zentiva k.s. | Granted and Under Opposition |
| EP16157001A | Aug, 2019 | Accord Healthcare | Granted and Under Opposition |
| EP16157001A | Aug, 2019 | PENTAFARMA, Sociedade Técnico-Medicinal, SA | Granted and Under Opposition |
| EP16157001A | Aug, 2019 | Synthon BV | Granted and Under Opposition |
| EP16157001A | Aug, 2019 | LEK Pharmaceuticals d.d. | Granted and Under Opposition |
| EP16157001A | Aug, 2019 | Pfizer Inc. | Granted and Under Opposition |
| EP16157001A | Jun, 2019 | Fresenius Kabi Deutschland GmbH | Granted and Under Opposition |
| EP16157001A | May, 2019 | Teva Pharmaceutical Industries Ltd. | Granted and Under Opposition |
| EP10006835A | Dec, 2016 | Generics (U.K.) Limited | Granted and Under Opposition |
| EP10006835A | Dec, 2016 | Teva Pharmaceutical Industries Ltd | Granted and Under Opposition |
| EP10006835A | Dec, 2016 | PENTAFARMA, Sociedade Técnico-Medicinal, SA | Granted and Under Opposition |
| EP10006835A | Dec, 2016 | Fresenius Medical Care AG & Co. KGaA | Granted and Under Opposition |
| EP10006835A | Dec, 2016 | LEK Pharmaceuticals d.d. | Granted and Under Opposition |
| EP10006835A | Dec, 2016 | Synthon Biopharmaceuticals B.V. | Granted and Under Opposition |
| EP10006835A | Dec, 2016 | Accord Healthcare | Granted and Under Opposition |
| EP10006835A | Dec, 2016 | HGF Limited | Granted and Under Opposition |
| EP10006835A | Dec, 2016 | Pfizer Inc. | Granted and Under Opposition |
| EP02709145A | Dec, 2011 | Accord Healthcare, Ltd | Revoked |
| EP02709145A | Dec, 2011 | Synthon B.V. | Revoked |
| EP02709145A | Dec, 2011 | Actavis group PTC ehf | Revoked |
| EP02709145A | Dec, 2011 | STADA Arzneimittel AG | Revoked |
| EP02709145A | Dec, 2011 | LEK Pharmaceuticals d.d. | Revoked |
| EP02709145A | Dec, 2011 | Deva Holding Anonim Sirketi | Revoked |
| EP02709145A | Dec, 2011 | hameln rds gmbh | Revoked |
US patents provide insights into the exclusivity only within the United States, but Velcade 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 Velcade's family patents as well as insights into ongoing legal events on those patents.
Velcade's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Velcade's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jul 25, 2022 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Velcade Generic API suppliers:
Bortezomib is the generic name for the brand Velcade. 19 different companies have already filed for the generic of Velcade, with Accord Hlthcare having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Velcade's generic
How can I launch a generic of Velcade before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Velcade's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Velcade'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 Velcade -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 3.5 mg/vial | 20 Nov, 2008 | 1 | 25 Jan, 2022 | Extinguished |
Alternative Brands for Velcade
Velcade which is used for treating multiple myeloma patients who have not responded to previous therapies., has several other brand drugs using the same active ingredient (Bortezomib). 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 | |
|---|---|---|
| Fresenius Kabi Usa |
| |
| Maia Pharms Inc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Bortezomib, Velcade's active ingredient. Check the complete list of approved generic manufacturers for Velcade
About Velcade
Velcade is a drug owned by Takeda Pharmaceuticals Usa Inc. It is used for treating multiple myeloma patients who have not responded to previous therapies. Velcade uses Bortezomib as an active ingredient. Velcade was launched by Takeda Pharms Usa in 2003.
Approval Date:
Velcade was approved by FDA for market use on 13 May, 2003.
Active Ingredient:
Velcade uses Bortezomib as the active ingredient. Check out other Drugs and Companies using Bortezomib ingredient
Treatment:
Velcade is used for treating multiple myeloma patients who have not responded to previous therapies.
Dosage:
Velcade is available in injectable form for intravenous, subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 3.5MG/VIAL | INJECTABLE | Prescription | INTRAVENOUS, SUBCUTANEOUS |