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MIRCERA

BLA

METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA | B125164 | HOFFMAN-LA ROCHE

1 product0 Purple Book patents

Biologic LOELicensure floor passed

No 12-year reference-product exclusivity floor found in the Purple Book

No 12-year reference-product exclusivity is listed in the Purple Book, and the reference product was first approved Nov. 14, 2007 — before BPCIA (March 23, 2010), so any 12-year exclusivity has long expired.

Marketing-entry ceiling (litigation risk)

Patents do not gate FDA licensure of a biosimilar — FDA licenses biosimilars (full or carved label) without adjudicating any patent. These are a practical marketing-entry ceiling resolved in the § 262(l) patent dance and ordinary litigation. A formulation/compound patent caps practical skinny entry via litigation (Regeneron v. Mylan); a method-of-use patent is carveable and gates nothing.

May. 30, 20446528 days remaining

Latest formulation/compound patent 11998643(formulation)· AI-discovered, not Purple-Book-listed · relevance 82/100. This caps practical skinny-label entry; it does not move the licensure floor above.

26 formulation/compound (cap skinny entry) · 5 method-of-use (carveable — gate nothing) · 19 device/diagnostic/manufacturing

Patent	Class	Expiration	Source
12403181	Method-of-use (carveable)	Aug. 28, 2045Active	Discovered
12379368	Other	Jul. 31, 2045Active	Discovered
12208142	Other	Jan. 23, 2045Active	Discovered
12018086	Other	Jun. 20, 2044Active	Discovered
11998643	Formulation/compound	May. 30, 2044Active	Discovered
11987637	Other	May. 16, 2044Active	Discovered
11939369	Formulation/compound	Mar. 21, 2044Active	Discovered
11938189	Formulation/compound	Mar. 21, 2044Active	Discovered
11779643	Other	Oct. 5, 2043Active	Discovered
11518781	Other	Dec. 1, 2042Active	Discovered
11090367	Method-of-use (carveable)	Aug. 12, 2041Active	Discovered
11028149	Other	Jun. 3, 2041Active	Discovered
10933141	Formulation/compound	Feb. 25, 2041Active	Discovered
10822415	Method-of-use (carveable)	Oct. 29, 2040Active	Discovered
10745731	Other	Aug. 13, 2040Active	Discovered

Showing 15 of 50 patents (latest expirations).

Disclaimer: Identifying an available carve-out is not a prediction that FDA will approve the particular carved label, nor that marketing it is free of infringement risk. For biologics, availability turns on exclusivities, not patents: FDA licenses a biosimilar (full or carved label) without adjudicating any patent, and patent disputes run through the § 262(l) patent dance and ordinary litigation, outside this availability view.

Discovered Patents

View all 69 patents →

Top 50 of 69 AI-discovered patents by relevance.

Composition

(15)

92/1006583272Grant: 2003-06-24 | Exp: 2023-06-19

92/1007128913Grant: 2006-10-31 | Exp: 2026-10-26

85/10011939369Grant: 2024-03-26 | Exp: 2044-03-21

75/1009981037Grant: 2018-05-29 | Exp: 2038-05-24

75/1007201897Grant: 2007-04-10 | Exp: 2027-04-05

72/1007193031Grant: 2007-03-20 | Exp: 2027-03-15

72/1009833520Grant: 2017-12-05 | Exp: 2037-11-30

70/1007479544Grant: 2009-01-20 | Exp: 2029-01-15

68/1007304034Grant: 2007-12-04 | Exp: 2027-11-29

65/1008476232Grant: 2013-07-02 | Exp: 2033-06-27

65/1006870033Grant: 2005-03-22 | Exp: 2025-03-17

65/1007635749Grant: 2009-12-22 | Exp: 2029-12-17

65/1007005504Grant: 2006-02-28 | Exp: 2026-02-23

62/1008293236Grant: 2012-10-23 | Exp: 2032-10-18

60/10010717776Grant: 2020-07-21 | Exp: 2040-07-16

Formulation

(11)

88/1007169754Grant: 2007-01-30 | Exp: 2027-01-25

85/1006277367Grant: 2001-08-21 | Exp: 2021-08-16

85/1007202208Grant: 2007-04-10 | Exp: 2027-04-05

82/10011998643Grant: 2024-06-04 | Exp: 2044-05-30

75/1006627187Grant: 2003-09-30 | Exp: 2023-09-25

75/1007504477Grant: 2009-03-17 | Exp: 2029-03-12

72/1007749520Grant: 2010-07-06 | Exp: 2030-07-01

60/10010933141Grant: 2021-03-02 | Exp: 2041-02-25

55/10011938189Grant: 2024-03-26 | Exp: 2044-03-21

55/10010525137Grant: 2020-01-07 | Exp: 2040-01-02

55/10010188735Grant: 2019-01-29 | Exp: 2039-01-24

Method of Use

(5)

75/1009168288Grant: 2015-10-27 | Exp: 2035-10-22

75/10010822415Grant: 2020-11-03 | Exp: 2040-10-29

72/10011090367Grant: 2021-08-17 | Exp: 2041-08-12

72/1008173129Grant: 2012-05-08 | Exp: 2032-05-03

72/10012403181Grant: 2025-09-02 | Exp: 2045-08-28

Manufacturing

(14)

85/1007214532Grant: 2007-05-08 | Exp: 2027-05-03

85/1006555373Grant: 2003-04-29 | Exp: 2023-04-24

85/10011518781Grant: 2022-12-06 | Exp: 2042-12-01

85/10012208142Grant: 2025-01-28 | Exp: 2045-01-23

85/1006548296Grant: 2003-04-15 | Exp: 2023-04-10

80/1006544748Grant: 2003-04-08 | Exp: 2023-04-03

75/1007214514Grant: 2007-05-08 | Exp: 2027-05-03

72/1007241442Grant: 2007-07-10 | Exp: 2027-07-05

72/1007897404Grant: 2011-03-01 | Exp: 2031-02-24

70/1006399333Grant: 2002-06-04 | Exp: 2022-05-30

65/1006391633Grant: 2002-05-21 | Exp: 2022-05-16

55/10011028149Grant: 2021-06-08 | Exp: 2041-06-03

55/10010745731Grant: 2020-08-18 | Exp: 2040-08-13

55/10011987637Grant: 2024-05-21 | Exp: 2044-05-16

Diagnostic

(5)

90/1009879325Grant: 2018-01-30 | Exp: 2038-01-25

88/10012379368Grant: 2025-08-05 | Exp: 2045-07-31

75/10011779643Grant: 2023-10-10 | Exp: 2043-10-05

72/1009541560Grant: 2017-01-10 | Exp: 2037-01-05

72/10012018086Grant: 2024-06-25 | Exp: 2044-06-20

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 125164 | 19 presentations

351(a) ReferenceLicensedCDERInjection

Proper Name

methoxy polyethylene glycol-epoetin beta

Applicant

Vifor (International) Inc.

Approval Date

28-Apr-16

Presentations

30MCG/0.3ML — Pre-Filled Syringe (Intravenous, Subcutaneous)

50MCG/0.3ML — Pre-Filled Syringe (Intravenous, Subcutaneous)

75MCG/0.3ML — Pre-Filled Syringe (Intravenous, Subcutaneous)

100MCG/0.3ML — Pre-Filled Syringe (Intravenous, Subcutaneous)

120MCG/0.3ML — Pre-Filled Syringe (Intravenous, Subcutaneous)

150MCG/0.3ML — Pre-Filled Syringe (Intravenous, Subcutaneous)

200MCG/0.3ML — Pre-Filled Syringe (Intravenous, Subcutaneous)

250MCG/0.3ML — Pre-Filled Syringe (Intravenous, Subcutaneous)

360MCG/0.6ML — Pre-Filled Syringe (Intravenous, Subcutaneous)

50MCG/ML — Single-Dose Vial (Intravenous, Subcutaneous)

100MCG/ML — Single-Dose Vial (Intravenous, Subcutaneous)

200MCG/ML — Single-Dose Vial (Intravenous, Subcutaneous)

300MCG/ML — Single-Dose Vial (Intravenous, Subcutaneous)

400MCG/ML — Single-Dose Vial (Intravenous, Subcutaneous)

600MCG/ML — Single-Dose Vial (Intravenous, Subcutaneous)

1,000MCG/ML — Single-Dose Vial (Intravenous, Subcutaneous)

400MCG/0.6ML — Pre-Filled Syringe (Intravenous, Subcutaneous)

600MCG/0.6ML — Pre-Filled Syringe (Intravenous, Subcutaneous)

800MCG/0.6ML — Pre-Filled Syringe (Intravenous, Subcutaneous)

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

Approval Letters

10 letters from Drugs@FDA

Date	Submission	Document
Jun 5, 2024	SUPPL -91	View Letter (PDF)
May 2, 2024	SUPPL -89	View Letter (PDF)
Apr 7, 2023	SUPPL -87	View Letter (PDF)
Aug 31, 2022	SUPPL -86	View Letter (PDF)
Jun 14, 2018	SUPPL -78	View Letter (PDF)
May 2, 2016	SUPPL -73	View Letter (PDF)
May 2, 2016	SUPPL -71	View Letter (PDF)
May 2, 2016	SUPPL -72	View Letter (PDF)
Aug 24, 2015	SUPPL -70	View Letter (PDF)
Oct 3, 2014	SUPPL -62	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.6MG/KG

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SOLUTION; INJECTION | Approved: Nov. 14, 2007

No patent or exclusivity listings for this strength.