Viewing data from:

OZILTUS

Interchangeable Biosimilar

DENOSUMAB-MOBZ | B761457 | AMNEAL PHARMS LLC

1 product0 Purple Book patents1 biosimilar

Biologic LOEBiosimilar competition

1 approved biosimilar

December 19, 2037(4187 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Dec. 19, 2037	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Jul. 31, 20456968 days remaining

Based on latest discovered patent 12378521(manufacturing) · relevance 75/100

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

Approved Biosimilars

OziltusBLA 761457IC

Discovered Patents

View all 260 patents →

Top 50 of 260 AI-discovered patents by relevance.

Composition

(30)

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Formulation

(6)

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

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

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

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

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

88/1009657090Grant: 2017-05-23 | Exp: 2037-05-18

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

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

Manufacturing

(9)

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

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

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

75/10012378521Grant: 2025-08-05 | Exp: 2045-07-31

75/10012325737Grant: 2025-06-10 | Exp: 2045-06-05

75/10011312745Grant: 2022-04-26 | Exp: 2042-04-21

75/1008263750Grant: 2012-09-11 | Exp: 2032-09-06

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 761457

InterchangeableLicensedCDERInjection

Proper Name

denosumab-mobz

Applicant

Amneal Pharmaceuticals LLC

Approval Date

19-Dec-25

Reference Product: Xgeva — denosumab

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 23, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 120MG/1.7ML (70MG/ML)

▴

INJECTABLE;SUBCUTANEOUS | Approved: 2025-12-19 00:00:00

No patent or exclusivity listings for this strength.