VELCADE Drug Patent Profile
✉ Email this page to a colleague
When do Velcade patents expire, and when can generic versions of Velcade launch?
Velcade is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.
This drug has twenty-seven patent family members in thirteen countries.
The generic ingredient in VELCADE is bortezomib. There are twenty drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the bortezomib profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Velcade
A generic version of VELCADE was approved as bortezomib by FRESENIUS KABI USA on November 6th, 2017.
Summary for VELCADE
International Patents: | 27 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 107 |
Clinical Trials: | 589 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for VELCADE |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VELCADE |
What excipients (inactive ingredients) are in VELCADE? | VELCADE excipients list |
DailyMed Link: | VELCADE at DailyMed |


Recent Clinical Trials for VELCADE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Academic and Community Cancer Research United | Phase 2 |
Medical College of Wisconsin | Phase 2 |
Abdullah Khan | Phase 1 |
Pharmacology for VELCADE
Drug Class | Proteasome Inhibitor |
Mechanism of Action | Proteasome Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for VELCADE
Paragraph IV (Patent) Challenges for VELCADE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
VELCADE | For Injection | bortezomib | 3.5 mg/vial | 021602 | 1 | 2008-11-20 |
US Patents and Regulatory Information for VELCADE
VELCADE is protected by two US patents and one FDA Regulatory Exclusivity.
Patents protecting VELCADE
Formulation of boronic acid compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Formulation of boronic acid compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
FDA Regulatory Exclusivity protecting VELCADE
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Takeda Pharms Usa | VELCADE | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021602-001 | May 13, 2003 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Takeda Pharms Usa | VELCADE | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021602-001 | May 13, 2003 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | |||
Takeda Pharms Usa | VELCADE | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021602-001 | May 13, 2003 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for VELCADE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Takeda Pharms Usa | VELCADE | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021602-001 | May 13, 2003 | See Plans and Pricing | See Plans and Pricing |
Takeda Pharms Usa | VELCADE | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021602-001 | May 13, 2003 | See Plans and Pricing | See Plans and Pricing |
Takeda Pharms Usa | VELCADE | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021602-001 | May 13, 2003 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VELCADE
See the table below for patents covering VELCADE around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Cyprus | 2484 | Boronic ester and acid compounds, synthesis and uses. | See Plans and Pricing |
Netherlands | 300151 | See Plans and Pricing | |
Spain | 2314540 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VELCADE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0788360 | CA 2004 00012 | Denmark | See Plans and Pricing | |
0788360 | SPC008/2004 | Ireland | See Plans and Pricing | SPC008/2004: 20050504, EXPIRES: 20190425 |
0788360 | 300151 | Netherlands | See Plans and Pricing | 300151, 20151027, EXPIRES: 20190425 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |