FDA Orange Book · active-ingredient family
Bortezomib
Bortezomib: 7 brands, 22 generics; first approved May 13, 2003; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 22 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
7
Generics (ANDA)
22
Listed patents
4
Next patent expiry
Nov 03, 2032
in 6 yr 4 mo
Brand (NDA) products
Originator applications
- BORTEZOMIBRLDRSSHILPANDA 2127822024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.5MG/1.4ML (2.5MG/ML) SOLUTION INTRAVENOUS, SUBCUTANEOUS Rx — - BORTEZOMIBRLDMAIA PHARMS INCNDA 21533120222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.5MG/3.5ML (1MG/ML) SOLUTION INTRAVENOUS Discontinued — 3.5MG/1.4ML (2.5MG/ML) SOLUTION INTRAVENOUS Discontinued — - BORTEZOMIBRLDACCORD HLTHCARENDA 21544120222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 2.5MG/ML (2.5MG/ML) SOLUTION INTRAVENOUS Discontinued — 3.5MG/1.4ML (2.5MG/ML) SOLUTION INTRAVENOUS Discontinued — - BORTEZOMIBRLDRSHOSPIRANDA 20919120222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/VIAL POWDER INTRAVENOUS, SUBCUTANEOUS Rx AP 2.5MG/VIAL POWDER INTRAVENOUS, SUBCUTANEOUS Rx AP - TAKEDA PHARMS USANDA 0216022003
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.5MG/VIAL INJECTABLE INTRAVENOUS, SUBCUTANEOUS Rx AP - BORTEZOMIBDR REDDYSNDA 2069272019
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.5MG/VIAL POWDER INTRAVENOUS Discontinued — - BORTEZOMIBFRESENIUS KABI USANDA 2050042017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.5MG/VIAL POWDER INTRAVENOUS Discontinued —
Generic (ANDA) products (22)
Abbreviated applications
- BORTEZOMIBGLANDANDA 21916720262 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 1MG/VIAL POWDER INTRAVENOUS, SUBCUTANEOUS Rx AP 2.5MG/VIAL POWDER INTRAVENOUS, SUBCUTANEOUS Rx AP - BORTEZOMIBSHUANGCHENGANDA 2165282025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.5MG/VIAL INJECTABLE INTRAVENOUS, SUBCUTANEOUS Rx AP - BORTEZOMIBVILIN BIO MEDANDA 2186882025
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.5MG/VIAL INJECTABLE INTRAVENOUS, SUBCUTANEOUS Rx AP - BORTEZOMIBHETERO LABS LTD VIANDA 2122042024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.5MG/VIAL INJECTABLE INTRAVENOUS, SUBCUTANEOUS Rx AP - BORTEZOMIBSCINOPHARM TAIWANANDA 2169122023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.5MG/VIAL INJECTABLE INTRAVENOUS, SUBCUTANEOUS Discontinued — - BORTEZOMIBPHARMOBEDIENTANDA 2051602022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.5MG/VIAL INJECTABLE INTRAVENOUS, SUBCUTANEOUS Discontinued — - BORTEZOMIBRELIANCE LIFE SCIANDA 2118982022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.5MG/VIAL INJECTABLE INTRAVENOUS, SUBCUTANEOUS Rx AP - BORTEZOMIBACCORD HLTHCAREANDA 2044052022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.5MG/VIAL INJECTABLE INTRAVENOUS, SUBCUTANEOUS Discontinued — - BORTEZOMIBCAPLIN ONE LABSANDA 2036542022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.5MG/VIAL INJECTABLE INTRAVENOUS, SUBCUTANEOUS Discontinued — - BORTEZOMIBDR REDDYSANDA 2029632022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.5MG/VIAL INJECTABLE INTRAVENOUS, SUBCUTANEOUS Rx AP - BORTEZOMIBHOSPIRAANDA 2084602022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.5MG/VIAL INJECTABLE INTRAVENOUS, SUBCUTANEOUS Rx AP - BORTEZOMIBJIANGSU HANSOH PHARMANDA 2150112022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.5MG/VIAL INJECTABLE INTRAVENOUS, SUBCUTANEOUS Rx AP - BORTEZOMIBMEITHEALANDA 2129582022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.5MG/VIAL INJECTABLE INTRAVENOUS, SUBCUTANEOUS Rx AP - BORTEZOMIBMSNANDA 2096222022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.5MG/VIAL INJECTABLE INTRAVENOUS, SUBCUTANEOUS Rx AP - BORTEZOMIBAPOTEXANDA 2055332022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.5MG/VIAL INJECTABLE INTRAVENOUS, SUBCUTANEOUS Rx AP - BORTEZOMIBBAXTER HLTHCARE CORPANDA 2138232022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.5MG/VIAL INJECTABLE INTRAVENOUS, SUBCUTANEOUS Discontinued — - BORTEZOMIBEUGIA PHARMAANDA 2128252022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.5MG/VIAL INJECTABLE INTRAVENOUS, SUBCUTANEOUS Rx AP - BORTEZOMIBFRESENIUS KABI USAANDA 2096592022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.5MG/VIAL INJECTABLE INTRAVENOUS, SUBCUTANEOUS Rx AP - BORTEZOMIBPHARMASCIENCE INCANDA 2083922022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.5MG/VIAL INJECTABLE INTRAVENOUS, SUBCUTANEOUS Rx AP - BORTEZOMIBQILU PHARM HAINANANDA 2108242022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.5MG/VIAL INJECTABLE INTRAVENOUS, SUBCUTANEOUS Rx AP - BORTEZOMIBTEVA PHARMS USAANDA 2058572022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.5MG/VIAL INJECTABLE INTRAVENOUS, SUBCUTANEOUS Discontinued — - BORTEZOMIBZYDUS PHARMSANDA 2102042022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 3.5MG/VIAL INJECTABLE INTRAVENOUS, SUBCUTANEOUS Rx AP
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8962572 | in 6 yr 4 mo | Product | |
| 11752164 | in 16 yr 4 mo | U-3632 | |
| 11679119 | in 16 yr 4 mo | U-3632 | |
| 12005069 | in 16 yr 4 mo | Product |
Approval history
FDA approval span
First approval
23 yr 7 mo ago
Most recent approval
7 mo ago
Approvals span 2003–2026 across 29 FDA applications.
Brand (NDA) 724%
Generic (ANDA) 2276%
Bortezomib: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
