Velcade Patent Expiration

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

(6 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

(9 years ago)

Expired
US6297217 Boronic ester and acid compounds, synthesis and uses
Oct, 2014

(9 years ago)

Expired
US6617317 Boronic ester and acid compositions
Oct, 2014

(9 years ago)

Expired
US7119080 Boronic ester and acid compounds, synthesis and uses
Oct, 2014

(9 years ago)

Expired
US6747150 Boronic ester and acid compounds, synthesis and uses
Oct, 2014

(9 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.

Given below is the list of recent legal activities going on the following patents of Velcade.

Activity Date Patent Number
Patent litigations
Expire Patent 12 Nov, 2018 US7119080
Maintenance Fee Reminder Mailed 21 May, 2018 US7119080
Post Issue Communication - Certificate of Correction 25 Jun, 2012 US6958319 (Litigated)
Email Notification 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 10 Oct, 2006 US7119080
Patent Issue Date Used in PTA Calculation 10 Oct, 2006 US7119080
Issue Notification Mailed 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

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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
Patent litigations
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

Velcade has patent protection in a total of 13 countries. It's US patent count contributes only to 27.3% of its total global patent coverage. 11 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Velcade.

Family Patents

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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 Generics:

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
Bortezomib
Maia Pharms Inc
Bortezomib


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


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