Viewing data from:

PROLIA

BLA

DENOSUMAB | B125320 | AMGEN

2 products57 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

September 2, 2040(5175 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	Jun. 1, 2022	Expired	Computed
7-Year Orphan	Dec. 5, 2021	Expired	Purple Book

Purple Book Patents (57)

Patent	Expiration	Status
10583397	Jul. 28, 2035	Active
10227627	Dec. 11, 2034	Active
10822630	Dec. 1, 2035	Active
10894972	May. 29, 2034	Active
11077404	May. 13, 2035	Active
11098079	Jul. 21, 2037	Active
11130980	Apr. 5, 2035	Active
11254963	Dec. 9, 2034	Active
11299760	Oct. 30, 2034	Active
11434514	May. 29, 2034	Active
8053236	Jan. 19, 2030	Active
8460896	Dec. 6, 2026	Active
8680248	Dec. 6, 2026	Active
10106829	Dec. 11, 2034	Active
10513723	Dec. 9, 2034	Active
10167492	Dec. 1, 2035	Active
9481901	May. 29, 2034	Active
9388447	Apr. 20, 2032	Active
9359435	May. 22, 2027	Active
9328134	Feb. 20, 2034	Active
9320816	Nov. 14, 2030	Active
9228168	Jan. 19, 2030	Active
9133493	Apr. 20, 2032	Active
9012178	Aug. 5, 2031	Active
8058418	Nov. 30, 2023	Expired
7928205	Feb. 12, 2027	Active
7427659	Mar. 15, 2025	Expired
7364736	Feb. 19, 2025	Expired
11685772	Jun. 29, 2032	Active
11319568	Mar. 10, 2034	Active
11275090	Jul. 2, 2037	Active
9371554	Dec. 14, 2032	Active
12025618	Aug. 26, 2039	Active
9881367	Aug. 9, 2037	Active
9803166	Sep. 29, 2034	Active
12059555	Sep. 2, 2040	Active
11492372	Mar. 11, 2034	Active
11293930	Mar. 26, 2033	Active
11192919	Nov. 13, 2035	Active
8217153	Jan. 5, 2027	Active
12084686	Mar. 10, 2034	Active
11786866	Oct. 21, 2035	Active
11744950	Nov. 21, 2039	Active
11634476	Jun. 29, 2032	Active
7662930	Apr. 24, 2027	Active
11427848	Jun. 4, 2035	Active
11459595	Mar. 10, 2034	Active
11486883	Mar. 26, 2033	Active
11946085	May. 29, 2034	Active
11952605	Mar. 10, 2034	Active
7888101	Apr. 6, 2027	Active
8247210	Dec. 6, 2026	Active
10421987	May. 29, 2034	Active
10655156	Dec. 11, 2034	Active
10907186	Dec. 11, 2034	Active
11292829	Jun. 29, 2032	Active
11384378	Jun. 4, 2035	Active

Discovered Patents

View all 102 patents →

Top 50 of 102 AI-discovered patents by relevance.

Composition

(10)

95/1007718776Grant: 2010-05-18 | Exp: 2030-05-13

95/1008367063Grant: 2013-02-05 | Exp: 2033-01-31

90/10010584174Grant: 2020-03-10 | Exp: 2040-03-05

75/1007820877Grant: 2010-10-26 | Exp: 2030-10-21

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

70/1007064244Grant: 2006-06-20 | Exp: 2026-06-15

70/1007709611Grant: 2010-05-04 | Exp: 2030-04-29

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

65/1008734796Grant: 2014-05-27 | Exp: 2034-05-22

65/1007435871Grant: 2008-10-14 | Exp: 2028-10-09

Formulation

(11)

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

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

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

78/1009352043Grant: 2016-05-31 | Exp: 2036-05-26

75/1008858935Grant: 2014-10-14 | Exp: 2034-10-09

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

68/10011040102Grant: 2021-06-22 | Exp: 2041-06-17

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

65/10012178873Grant: 2024-12-31 | Exp: 2044-12-26

65/10012318447Grant: 2025-06-03 | Exp: 2045-05-29

65/1007956160Grant: 2011-06-07 | Exp: 2031-06-02

Method of Use

(3)

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

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

72/1006790823Grant: 2004-09-14 | Exp: 2024-09-09

Manufacturing

(16)

95/10011946085Grant: 2024-04-02 | Exp: 2044-03-28

95/10012084686Grant: 2024-09-10 | Exp: 2044-09-05

91/10011299760Grant: 2022-04-12 | Exp: 2042-04-07

85/10011827692Grant: 2023-11-28 | Exp: 2043-11-23

85/10011434514Grant: 2022-09-06 | Exp: 2042-09-01

82/10011447547Grant: 2022-09-20 | Exp: 2042-09-15

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

75/1006673986Grant: 2004-01-06 | Exp: 2024-01-01

75/10011685772Grant: 2023-06-27 | Exp: 2043-06-22

72/10011459595Grant: 2022-10-04 | Exp: 2042-09-29

72/10011952605Grant: 2024-04-09 | Exp: 2044-04-04

65/1007049426Grant: 2006-05-23 | Exp: 2026-05-18

65/10011293930Grant: 2022-04-05 | Exp: 2042-03-31

65/1006833268Grant: 2004-12-21 | Exp: 2024-12-16

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

65/1007547817Grant: 2009-06-16 | Exp: 2029-06-11

Device

(10)

72/10011904143Grant: 2024-02-20 | Exp: 2044-02-15

72/10010492990Grant: 2019-12-03 | Exp: 2039-11-28

70/10012290666Grant: 2025-05-06 | Exp: 2045-05-01

70/10012390583Grant: 2025-08-19 | Exp: 2045-08-14

65/10012434015Grant: 2025-10-07 | Exp: 2045-10-02

65/10010646664Grant: 2020-05-12 | Exp: 2040-05-07

65/10011389588Grant: 2022-07-19 | Exp: 2042-07-14

65/10011738138Grant: 2023-08-29 | Exp: 2043-08-24

65/10011944798Grant: 2024-04-02 | Exp: 2044-03-28

65/10010398854Grant: 2019-09-03 | Exp: 2039-08-29

PTAB Proceedings

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

Patent Reexaminations

1 reexamination on OB patents from USPTO Patent Center

90/012,492Ex PartePending

Patent: 7427659Filed: 2012-09-11

PROCESS FOR PURIFYING PROTEINS IN A HYDROPHOBIC INTERACTION CHROMATOGRAPHY FLOW-THROUGH FRACTION

Recent Events

2013-05-21RXLITSRLitigation Search Conducted

2012-10-02RXLITSRLitigation Search Conducted

Source: USPTO Patent Center. Ex parte and inter partes reexamination proceedings.

Hatch-Waxman Litigation

9 cases on OB patents (4 active) from PACER

Case	Court	Filed	Status	Judge
AMGEN INC. et al v. ALKEM LABORATORIES LTD. et al 1:2025cv17596 35 patentsdenosumab	D.N.J.	2025-11-14	Active	—
AMGEN INC. et al v. AMNEAL PHARMACEUTICALS, INC. et al 1:2025cv17278 31 patentsdenosumab	D.N.J.	2025-11-06	Active	—
AMGEN INC. et al v. DR. REDDY'S LABORATORIES LTD. et al 1:2025cv17277 31 patentsdenosumab	D.N.J.	2025-11-06	Active	—
Amgen Inc. et al v. Biocon Biologics, Inc. et al 1:2025cv13358 34 patentsdenosumab	D.N.J.	2025-07-16	Terminated 2026-01-22	—
Amgen Inc. et al v. Biocon Biologics, Inc. et al 1:2025cv11867 34 patentsdenosumab	D. Mass.	2025-06-30	Terminated 2025-07-15	—
AMGEN INC. et al v. SHANGHAI HENLIUS BIOTECH, INC. et al 1:2025cv12160 26 patentsdenosumab	D.N.J.	2025-06-25	Active	—
AMGEN INC. et al v. HIKMA PHARMACEUTICALS USA INC. et al 1:2025cv12152 32 patentsdenosumab	D.N.J.	2025-06-25	Terminated 2025-11-24	—
Amgen Inc. et al v. Fresenius Kabi USA, LLC et al 1:2025cv01080 33 patentsdenosumab	D.N.J.	2025-02-07	Terminated 2025-03-11	—
Amgen Inc. et al v. Accord Biopharma, Inc. et al 5:2024cv00642 34 patentsdenosumab	NCED	2024-11-13	Terminated 2025-02-14	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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 125320 | 3 presentations | 57 patents

351(a) ReferenceLicensedCDERInjection

Proper Name

denosumab

Applicant

Amgen Inc.

Approval Date

1-Jun-10

Listed Patents

Patent Number	Expiration
10583397	July 28, 2035
10227627	December 11, 2034
10822630	December 1, 2035
10894972	May 29, 2034
11077404	May 13, 2035
11098079	July 21, 2037
11130980	April 5, 2035
11254963	December 9, 2034
11299760	October 30, 2034
11434514	May 29, 2034
8053236	January 19, 2030
8460896	December 6, 2026
8680248	December 6, 2026
10106829	December 11, 2034
10513723	December 9, 2034
10167492	December 1, 2035
9481901	May 29, 2034
9388447	April 20, 2032
9359435	May 22, 2027
9328134	February 20, 2034
9320816	November 14, 2030
9228168	January 19, 2030
9133493	April 20, 2032
9012178	August 5, 2031
8058418	November 30, 2023
7928205	February 12, 2027
7427659	March 15, 2025
7364736	February 19, 2025
11685772	June 29, 2032
11319568	March 10, 2034
11275090	July 2, 2037
9371554	December 14, 2032
12025618	August 26, 2039
9881367	August 9, 2037
9803166	September 29, 2034
12059555	September 2, 2040
11492372	March 11, 2034
11293930	March 26, 2033
11192919	November 13, 2035
8217153	January 5, 2027
12084686	March 10, 2034
11786866	October 21, 2035
11744950	November 21, 2039
11634476	June 29, 2032
7662930	April 24, 2027
11427848	June 4, 2035
11459595	March 10, 2034
11486883	March 26, 2033
11946085	May 29, 2034
11952605	March 10, 2034
7888101	April 6, 2027
8247210	December 6, 2026
10421987	May 29, 2034
10655156	December 11, 2034
10907186	December 11, 2034
11292829	June 29, 2032
11384378	June 4, 2035

Presentations

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

60MG/ML — Single-Dose Vial (Subcutaneous)

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

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

Approval Letters

57 letters from Drugs@FDA

Date	Submission	Document
Jun 24, 2026	SUPPL -224	View Letter (PDF)
Jun 24, 2026	SUPPL -225	View Letter (PDF)
Jun 2, 2025	SUPPL -222	View Letter (PDF)
May 29, 2025	SUPPL -186	View Letter (PDF)
May 27, 2025	SUPPL -219	View Letter (PDF)
May 5, 2025	SUPPL -221	View Letter (PDF)
Apr 10, 2024	SUPPL -218	View Letter (PDF)
Mar 5, 2024	SUPPL -213	View Letter (PDF)
Mar 5, 2024	SUPPL -217	View Letter (PDF)
Jan 22, 2024	SUPPL -216	View Letter (PDF)
Jan 4, 2023	SUPPL -211	View Letter (PDF)
May 20, 2022	SUPPL -210	View Letter (PDF)
May 13, 2021	SUPPL -207	View Letter (PDF)
Jun 10, 2020	SUPPL -203	View Letter (PDF)
Apr 24, 2020	SUPPL -205	View Letter (PDF)
Feb 11, 2020	SUPPL -201	View Letter (PDF)
Oct 3, 2019	SUPPL -202	View Letter (PDF)
Jul 30, 2019	SUPPL -198	View Letter (PDF)
Jun 4, 2019	SUPPL -195	View Letter (PDF)
May 13, 2019	SUPPL -196	View Letter (PDF)
May 13, 2019	SUPPL -199	View Letter (PDF)
May 2, 2019	SUPPL -200	View Letter (PDF)
Jun 14, 2018	SUPPL -191	View Letter (PDF)
Jan 26, 2018	SUPPL -185	View Letter (PDF)
Jan 4, 2018	SUPPL -182	View Letter (PDF)
May 30, 2017	SUPPL -181	View Letter (PDF)
Jan 31, 2017	SUPPL -180	View Letter (PDF)
Oct 17, 2016	SUPPL -178	View Letter (PDF)
Aug 5, 2016	SUPPL -17	View Letter (PDF)
Aug 5, 2016	SUPPL -17	View Letter (PDF)
Aug 5, 2016	SUPPL -17	View Letter (PDF)
Aug 5, 2016	SUPPL -17	View Letter (PDF)
Aug 5, 2016	SUPPL -17	View Letter (PDF)
Aug 5, 2016	SUPPL -17	View Letter (PDF)
Aug 5, 2016	SUPPL -17	View Letter (PDF)
Mar 4, 2016	SUPPL -177	View Letter (PDF)
Jun 10, 2015	SUPPL -168	View Letter (PDF)
May 26, 2015	SUPPL -162	View Letter (PDF)
Apr 13, 2015	SUPPL -174	View Letter (PDF)
Mar 2, 2015	SUPPL -170	View Letter (PDF)
Dec 9, 2014	SUPPL -160	View Letter (PDF)
Jun 18, 2014	SUPPL -150	View Letter (PDF)
Jun 5, 2014	SUPPL -155	View Letter (PDF)
Aug 27, 2013	SUPPL -124	View Letter (PDF)
Aug 27, 2013	SUPPL -114	View Letter (PDF)
Jul 8, 2013	SUPPL -113	View Letter (PDF)
Jun 13, 2013	SUPPL -94	View Letter (PDF)
Feb 20, 2013	SUPPL -80	View Letter (PDF)
Sep 24, 2012	SUPPL -51	View Letter (PDF)
Sep 18, 2012	SUPPL -85	View Letter (PDF)
Jun 11, 2012	SUPPL -78	View Letter (PDF)
May 14, 2012	SUPPL -53	View Letter (PDF)
May 2, 2012	SUPPL -54	View Letter (PDF)
Sep 20, 2011	SUPPL -6	View Letter (PDF)
Sep 20, 2011	SUPPL -5	View Letter (PDF)
Nov 22, 2010	SUPPL -7	View Letter (PDF)
Jun 4, 2010	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 60MG/ML

▴

INJECTABLE; SUBCUTANEOUS | Approved: 2010-06-01 00:00:00

No patent or exclusivity listings for this strength.

#002 — 70MG/ML

▾

INJECTABLE; SUBCUTANEOUS | Approved: 2010-06-01 00:00:00