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BLA

NIVOLUMAB;HYALURONIDASE-NVHY | B761381 | BRISTOL-MYERS SQUIBB

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

December 27, 2036(3830 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Dec. 27, 2036	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Aug. 28, 20456996 days remaining

Based on latest discovered patent 12403174(composition) · relevance 92/100

Estimate based on AI-discovered patents. No patents are officially listed in the Purple Book for this product.

Discovered Patents

View all 314 patents →

Top 50 of 314 AI-discovered patents by relevance.

Composition

(16)

92/10012403174Grant: 2025-09-02 | Exp: 2045-08-28

92/10010358463Grant: 2019-07-23 | Exp: 2039-07-18

92/10011560430Grant: 2023-01-24 | Exp: 2043-01-19

90/10012258407Grant: 2025-03-25 | Exp: 2045-03-20

88/10010465007Grant: 2019-11-05 | Exp: 2039-10-31

88/10011136408Grant: 2021-10-05 | Exp: 2041-09-30

85/1007507580Grant: 2009-03-24 | Exp: 2029-03-19

85/1009944678Grant: 2018-04-17 | Exp: 2038-04-12

85/1009872852Grant: 2018-01-23 | Exp: 2038-01-18

85/1009732119Grant: 2017-08-15 | Exp: 2037-08-10

85/1007858759Grant: 2010-12-28 | Exp: 2030-12-23

85/10010988507Grant: 2021-04-27 | Exp: 2041-04-22

85/1009856292Grant: 2018-01-02 | Exp: 2037-12-28

85/1009499838Grant: 2016-11-22 | Exp: 2036-11-17

85/10010640559Grant: 2020-05-05 | Exp: 2040-04-30

85/1009308236Grant: 2016-04-12 | Exp: 2036-04-07

Method of Use

(28)

95/10010266595Grant: 2019-04-23 | Exp: 2039-04-18

95/1009856320Grant: 2018-01-02 | Exp: 2037-12-28

95/10011083790Grant: 2021-08-10 | Exp: 2041-08-05

95/10012152075Grant: 2024-11-26 | Exp: 2044-11-21

95/10010138299Grant: 2018-11-27 | Exp: 2038-11-22

92/10010316091Grant: 2019-06-11 | Exp: 2039-06-06

92/10011566073Grant: 2023-01-31 | Exp: 2043-01-26

92/10010266594Grant: 2019-04-23 | Exp: 2039-04-18

91/10010577423Grant: 2020-03-03 | Exp: 2040-02-27

90/10010072082Grant: 2018-09-11 | Exp: 2038-09-06

90/10011542312Grant: 2023-01-03 | Exp: 2042-12-29

89/10012227576Grant: 2025-02-18 | Exp: 2045-02-13

88/10010584170Grant: 2020-03-10 | Exp: 2040-03-05

88/1007070776Grant: 2006-07-04 | Exp: 2026-06-29

88/10010323093Grant: 2019-06-18 | Exp: 2039-06-13

88/10010604575Grant: 2020-03-31 | Exp: 2040-03-26

88/10010266596Grant: 2019-04-23 | Exp: 2039-04-18

88/10010308714Grant: 2019-06-04 | Exp: 2039-05-30

88/1007101962Grant: 2006-09-05 | Exp: 2026-08-31

87/10010316090Grant: 2019-06-11 | Exp: 2039-06-06

86/10010544224Grant: 2020-01-28 | Exp: 2040-01-23

85/10011306143Grant: 2022-04-19 | Exp: 2042-04-14

85/10011078278Grant: 2021-08-03 | Exp: 2041-07-29

85/10011072657Grant: 2021-07-27 | Exp: 2041-07-22

85/1007414171Grant: 2008-08-19 | Exp: 2028-08-14

85/10011103579Grant: 2021-08-31 | Exp: 2041-08-26

85/10011332529Grant: 2022-05-17 | Exp: 2042-05-12

85/10011767361Grant: 2023-09-26 | Exp: 2043-09-21

Manufacturing

(2)

85/10010076103Grant: 2018-09-18 | Exp: 2038-09-13

85/1009426970Grant: 2016-08-30 | Exp: 2036-08-25

Diagnostic

(4)

90/10011899017Grant: 2024-02-13 | Exp: 2044-02-08

90/10010718773Grant: 2020-07-21 | Exp: 2040-07-16

85/10011585817Grant: 2023-02-21 | Exp: 2043-02-16

85/10010613092Grant: 2020-04-07 | Exp: 2040-04-02

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Purple Book (Biologics)

BLA 761381 | 2 presentations

351(a) ReferenceLicensedCDERInjection

Proper Name

nivolumab and hyaluronidase-nvhy

Applicant

Bristol-Myers Squibb Company

Approval Date

27-Dec-24

Presentations

600MG/5ML;10,000UNITS/5ML (120MG/2,000UNITS/ML) — Single-Dose Vial (Subcutaneous)

300MG/2.5ML;5,000UNITS/2.5ML (120MG/2,000UNITS/ML) — Single-Dose Vial (Subcutaneous)

Source: FDA Purple Book (purplebooksearch.fda.gov).

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
May 13, 2026	SUPPL -12	View Letter (PDF)
Nov 25, 2025	SUPPL -5	View Letter (PDF)
Oct 31, 2025	SUPPL -1	View Letter (PDF)
Oct 28, 2025	SUPPL -2	View Letter (PDF)
May 28, 2025	SUPPL -8	View Letter (PDF)
Jan 3, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 600MG;10000UNITS PER5ML(120MG/2000UNITS PER ML)

▴

INJECTABLE;SUBCUTANEOUS | Approved: 2024-12-27 00:00:00

No patent or exclusivity listings for this strength.