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VELCADE Drug Profile
» See Plans and Pricing
When do Velcade patents expire, and when can generic versions of Velcade launch?
Velcade is a drug marketed by Millennium Pharms 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.
US ANDA 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 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 101 |
| Clinical Trials: | 559 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for VELCADE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VELCADE |
| 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 |
| Karyopharm Therapeutics Inc | Phase 2 |
| Medical College of Wisconsin | Phase 2 |
Pharmacology for VELCADE
| Drug Class | Proteasome Inhibitor |
| Mechanism of Action | Proteasome Inhibitors |
Paragraph IV (Patent) Challenges for VELCADE
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| VELCADE | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | bortezomib | 021602 | 2008-11-20 |
US Patents and Regulatory Information for VELCADE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Millennium Pharms | VELCADE | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021602-001 | May 13, 2003 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Millennium Pharms | VELCADE | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021602-001 | May 13, 2003 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Millennium Pharms | VELCADE | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021602-001 | May 13, 2003 | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | |||
| Millennium Pharms | VELCADE | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021602-001 | May 13, 2003 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| >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 |
|---|---|---|---|---|---|---|---|
| Millennium Pharms | VELCADE | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021602-001 | May 13, 2003 | Start Trial | Start Trial |
| Millennium Pharms | VELCADE | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021602-001 | May 13, 2003 | Start Trial | Start Trial |
| Millennium Pharms | VELCADE | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021602-001 | May 13, 2003 | Start Trial | Start Trial |
| Millennium Pharms | VELCADE | bortezomib | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 021602-001 | May 13, 2003 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VELCADE
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Luxembourg | 91083 | Start Trial |
| European Patent Office | 1312609 | Start Trial |
| Germany | 69535866 | Start Trial |
| Canada | 2435124 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for VELCADE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0788360 | SPC/GB04/021 | United Kingdom | Start Trial | PRODUCT NAME: BORTEZOMIB OR PHARMACEUTICALLY ACCEPTABLE ESTER THEREOF, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/274/001 20040428 |
| 0788360 | 300151 | Netherlands | Start Trial | 300151, 20151027, EXPIRES: 20190425 |
| 0788360 | C00788360/01 | Switzerland | Start Trial | FORMER REPRESENTANTIVE: BOVARD AG PATENTANWAELTE, CH |
| 0788360 | SPC008/2004 | Ireland | Start Trial | SPC008/2004: 20050504, EXPIRES: 20190425 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
