Viewing data from:

EVENITY

BLA

ROMOSOZUMAB-AQQG | B761062 | AMGEN INC

1 product0 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

April 9, 2031(1741 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Apr. 9, 2031	Active	Computed

Purple Book Patents

No listed patents in Purple Book.

Estimated Patent LOE

Sep. 18, 20457017 days remaining

Based on latest discovered patent 12421304(method of use) · relevance 88/100

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

Discovered Patents

View all 85 patents →

Top 50 of 85 AI-discovered patents by relevance.

Composition

(19)

92/10010800839Grant: 2020-10-13 | Exp: 2040-10-08

92/1008986685Grant: 2015-03-24 | Exp: 2035-03-19

90/10012297260Grant: 2025-05-13 | Exp: 2045-05-08

88/1009879072Grant: 2018-01-30 | Exp: 2038-01-25

85/1009133272Grant: 2015-09-15 | Exp: 2035-09-10

85/1009708375Grant: 2017-07-18 | Exp: 2037-07-13

85/1009822173Grant: 2017-11-21 | Exp: 2037-11-16

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

72/1007820877Grant: 2010-10-26 | Exp: 2030-10-21

70/1007435871Grant: 2008-10-14 | Exp: 2028-10-09

70/10011198732Grant: 2021-12-14 | Exp: 2041-12-09

65/10010829551Grant: 2020-11-10 | Exp: 2040-11-05

65/1009562108Grant: 2017-02-07 | Exp: 2037-02-02

65/1009073999Grant: 2015-07-07 | Exp: 2035-07-02

60/1009308258Grant: 2016-04-12 | Exp: 2036-04-07

60/10010759844Grant: 2020-09-01 | Exp: 2040-08-27

55/10011993663Grant: 2024-05-28 | Exp: 2044-05-23

55/1009321840Grant: 2016-04-26 | Exp: 2036-04-21

55/1009200060Grant: 2015-12-01 | Exp: 2035-11-26

Formulation

(10)

95/10010064946Grant: 2018-09-04 | Exp: 2038-08-30

95/1009920114Grant: 2018-03-20 | Exp: 2038-03-15

95/10011040102Grant: 2021-06-22 | Exp: 2041-06-17

92/10012178873Grant: 2024-12-31 | Exp: 2044-12-26

92/1009617333Grant: 2017-04-11 | Exp: 2037-04-06

92/1009352043Grant: 2016-05-31 | Exp: 2036-05-26

78/10012257343Grant: 2025-03-25 | Exp: 2045-03-20

72/10010653781Grant: 2020-05-19 | Exp: 2040-05-14

68/10011813328Grant: 2023-11-14 | Exp: 2043-11-09

65/10012103979Grant: 2024-10-01 | Exp: 2044-09-26

Method of Use

(11)

94/1009089553Grant: 2015-07-28 | Exp: 2035-07-23

92/1008017120Grant: 2011-09-13 | Exp: 2031-09-08

92/1008329176Grant: 2012-12-11 | Exp: 2032-12-06

92/1008440193Grant: 2013-05-14 | Exp: 2033-05-09

92/10010538584Grant: 2020-01-21 | Exp: 2040-01-16

92/10011091537Grant: 2021-08-17 | Exp: 2041-08-12

90/10010273293Grant: 2019-04-30 | Exp: 2039-04-25

88/10012421304Grant: 2025-09-23 | Exp: 2045-09-18

88/10010799583Grant: 2020-10-13 | Exp: 2040-10-08

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

72/1009913900Grant: 2018-03-13 | Exp: 2038-03-08

Manufacturing

(10)

75/1006833268Grant: 2004-12-21 | Exp: 2024-12-16

65/10010822630Grant: 2020-11-03 | Exp: 2040-10-29

65/1006673986Grant: 2004-01-06 | Exp: 2024-01-01

65/1008263750Grant: 2012-09-11 | Exp: 2032-09-06

60/1007049426Grant: 2006-05-23 | Exp: 2026-05-18

58/10012325737Grant: 2025-06-10 | Exp: 2045-06-05

56/1009012178Grant: 2015-04-21 | Exp: 2035-04-16

55/10010513723Grant: 2019-12-24 | Exp: 2039-12-19

55/1008969036Grant: 2015-03-03 | Exp: 2035-02-26

55/1009359435Grant: 2016-06-07 | Exp: 2036-06-02

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 761062

351(a) ReferenceLicensedCDERInjection

Proper Name

romosozumab-aqqg

Applicant

Amgen Inc.

Approval Date

9-Apr-19

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Dec 26, 2019	SUPPL -2	View Letter (PDF)
Apr 10, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 105MG/1.17ML

▴

INJECTABLE;INJECTION | Approved: 2019-04-09 00:00:00

No patent or exclusivity listings for this strength.