VELCADE Drug Patent Profile
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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 |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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