Is there a generic for Bortezomib?

Yes. The FDA Orange Book lists 22 approved generic (ANDA) applications for Bortezomib, referencing the brand BORTEZOMIB. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Bortezomib?

BORTEZOMIB (NDA 212782, SHILPA) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Bortezomib?

The Orange Book lists 4 patents against Bortezomib products, with the earliest listed expiry in 2032. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Bortezomib are approved?

Bortezomib is approved in the following dosage forms: injectable, powder, solution.

FDA Orange Book · active-ingredient family

Bortezomib

Bortezomib is approved as 7 brand and 22 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:BORTEZOMIB · NDA 212782

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · injectable, powder, solution

Product	Applicant	Application	TE	Approved
BORTEZOMIBRLD	SHILPA	NDA 212782	—	Aug 26, 2024
BORTEZOMIBRLD×2	MAIA PHARMS INC	NDA 215331	—	Jul 27, 2022
BORTEZOMIBRLD×2	ACCORD HLTHCARE	NDA 215441	—	Jul 26, 2022
BORTEZOMIBRLD×2	HOSPIRA	NDA 209191	AP	May 02, 2022
VELCADERLD	TAKEDA PHARMS USA	NDA 021602	AP	May 13, 2003
BORTEZOMIB	DR REDDYS	NDA 206927	—	Oct 04, 2019
BORTEZOMIB	FRESENIUS KABI USA	NDA 205004	—	Nov 06, 2017

Generic (ANDA) products (22)

Product	Applicant	Application	TE	Approved
BORTEZOMIB×2	GLAND	ANDA 219167	AP	Jan 06, 2026
BORTEZOMIB	SHUANGCHENG	ANDA 216528	AP	Dec 17, 2025
BORTEZOMIB	VILIN BIO MED	ANDA 218688	AP	Jun 02, 2025
BORTEZOMIB	HETERO LABS LTD VI	ANDA 212204	AP	May 03, 2024
BORTEZOMIB	SCINOPHARM TAIWAN	ANDA 216912	—	Sep 26, 2023
BORTEZOMIB	PHARMOBEDIENT	ANDA 205160	—	Oct 31, 2022
BORTEZOMIB	RELIANCE LIFE SCI	ANDA 211898	AP	Oct 11, 2022
BORTEZOMIB	ACCORD HLTHCARE	ANDA 204405	—	Jul 26, 2022
BORTEZOMIB	CAPLIN ONE LABS	ANDA 203654	—	Jul 26, 2022
BORTEZOMIB	DR REDDYS	ANDA 202963	AP	Jul 26, 2022
BORTEZOMIB	HOSPIRA	ANDA 208460	AP	Jul 26, 2022
BORTEZOMIB	JIANGSU HANSOH PHARM	ANDA 215011	AP	Jul 26, 2022
BORTEZOMIB	MEITHEAL	ANDA 212958	AP	Jul 26, 2022
BORTEZOMIB	MSN	ANDA 209622	AP	Jul 26, 2022
BORTEZOMIB	APOTEX	ANDA 205533	AP	May 02, 2022
BORTEZOMIB	BAXTER HLTHCARE CORP	ANDA 213823	—	May 02, 2022
BORTEZOMIB	EUGIA PHARMA	ANDA 212825	AP	May 02, 2022
BORTEZOMIB	FRESENIUS KABI USA	ANDA 209659	AP	May 02, 2022
BORTEZOMIB	PHARMASCIENCE INC	ANDA 208392	AP	May 02, 2022
BORTEZOMIB	QILU PHARM HAINAN	ANDA 210824	AP	May 02, 2022
BORTEZOMIB	TEVA PHARMS USA	ANDA 205857	—	May 02, 2022
BORTEZOMIB	ZYDUS PHARMS	ANDA 210204	AP	May 02, 2022

Listed patents (4)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8962572	Nov 03, 2032	in 6 yr 6 mo	Product
11752164	Sep 23, 2042	in 16 yr 6 mo	U-3632
11679119	Sep 23, 2042	in 16 yr 6 mo	U-3632
12005069	Sep 23, 2042	in 16 yr 6 mo	Product

Bortezomib — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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