Viewing data from:

BOMYNTRA

Interchangeable Biosimilar

DENOSUMAB-BNHT | B761398 | FRESENIUS KABI USA LLC

2 products0 Purple Book patents3 biosimilars

Biologic LOEBiosimilar competition

3 approved biosimilars

March 25, 2037(3918 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Mar. 25, 2037	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Apr. 17, 20456863 days remaining

Based on latest discovered patent 12281176(composition) · relevance 90/100

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

Approved Biosimilars

ConexxenceBLA 761398ICBomyntraBLA 761398ICBomyntraBLA 761398IC

Discovered Patents

View all 267 patents →

Top 50 of 267 AI-discovered patents by relevance.

Composition

(30)

92/1009340621Grant: 2016-05-17 | Exp: 2036-05-12

90/1006271346Grant: 2001-08-07 | Exp: 2021-08-02

90/10012281176Grant: 2025-04-22 | Exp: 2045-04-17

90/10011891435Grant: 2024-02-06 | Exp: 2044-02-01

88/1008604174Grant: 2013-12-10 | Exp: 2033-12-05

85/1006221675Grant: 2001-04-24 | Exp: 2021-04-19

85/1006417158Grant: 2002-07-09 | Exp: 2022-07-04

85/10010829551Grant: 2020-11-10 | Exp: 2040-11-05

85/10011059908Grant: 2021-07-13 | Exp: 2041-07-08

85/1007282483Grant: 2007-10-16 | Exp: 2027-10-11

85/10011427627Grant: 2022-08-30 | Exp: 2042-08-25

85/10011198732Grant: 2021-12-14 | Exp: 2041-12-09

85/10010597456Grant: 2020-03-24 | Exp: 2040-03-19

82/1007253007Grant: 2007-08-07 | Exp: 2027-08-02

82/10011926672Grant: 2024-03-12 | Exp: 2044-03-07

80/10011661462Grant: 2023-05-30 | Exp: 2043-05-25

80/10010287348Grant: 2019-05-14 | Exp: 2039-05-09

80/1007414122Grant: 2008-08-19 | Exp: 2028-08-14

80/1007951368Grant: 2011-05-31 | Exp: 2031-05-26

78/10011180564Grant: 2021-11-23 | Exp: 2041-11-18

78/1007737111Grant: 2010-06-15 | Exp: 2030-06-10

78/10010919975Grant: 2021-02-16 | Exp: 2041-02-11

75/1007169905Grant: 2007-01-30 | Exp: 2027-01-25

75/1008367063Grant: 2013-02-05 | Exp: 2033-01-31

75/1008895008Grant: 2014-11-25 | Exp: 2034-11-20

75/10010266598Grant: 2019-04-23 | Exp: 2039-04-18

75/10010053507Grant: 2018-08-21 | Exp: 2038-08-16

75/1009562107Grant: 2017-02-07 | Exp: 2037-02-02

75/1007166707Grant: 2007-01-23 | Exp: 2027-01-18

75/1008734796Grant: 2014-05-27 | Exp: 2034-05-22

Formulation

(6)

95/10011192952Grant: 2021-12-07 | Exp: 2041-12-02

90/10011873343Grant: 2024-01-16 | Exp: 2044-01-11

85/10011773184Grant: 2023-10-03 | Exp: 2043-09-28

85/10010808033Grant: 2020-10-20 | Exp: 2040-10-15

75/10011040102Grant: 2021-06-22 | Exp: 2041-06-17

75/1009320797Grant: 2016-04-26 | Exp: 2036-04-21

Method of Use

(4)

92/10010143747Grant: 2018-12-04 | Exp: 2038-11-29

85/10010246513Grant: 2019-04-02 | Exp: 2039-03-28

80/10011505612Grant: 2022-11-22 | Exp: 2042-11-17

78/1006835547Grant: 2004-12-28 | Exp: 2024-12-23

Manufacturing

(9)

85/1007238776Grant: 2007-07-03 | Exp: 2027-06-28

85/10012241086Grant: 2025-03-04 | Exp: 2045-02-27

80/1006657103Grant: 2003-12-02 | Exp: 2023-11-27

78/10011486883Grant: 2022-11-01 | Exp: 2042-10-27

75/10010577392Grant: 2020-03-03 | Exp: 2040-02-27

75/10010822630Grant: 2020-11-03 | Exp: 2040-10-29

75/1007049426Grant: 2006-05-23 | Exp: 2026-05-18

75/1008809051Grant: 2014-08-19 | Exp: 2034-08-14

75/1009388447Grant: 2016-07-12 | Exp: 2036-07-07

Device

(1)

75/10011571511Grant: 2023-02-07 | Exp: 2043-02-02

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 761398 | 3 presentations

InterchangeableLicensedCDERInjection

Proper Name

denosumab-bnht

Applicant

Fresenius Kabi USA, LLC

Approval Date

25-Mar-25

Reference Product: Prolia — denosumab

Presentations

60MG/ML — Pre-Filled Syringe (Subcutaneous)

120MG/1.7ML (70MG/ML) — Single-Dose Vial (Subcutaneous)

120MG/1.7ML (70MG/ML) — Pre-Filled Syringe (Subcutaneous)

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Oct 31, 2025	ORIG -2	View Letter (PDF)
Mar 27, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 120MG/1.7ML (70 MG/ML)

▴

INJECTION | Approved: 2025-03-25 00:00:00

No patent or exclusivity listings for this strength.

#002 — 60MG/ML

▾

INJECTION | Approved: 2025-03-25 00:00:00