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BLA

AFLIBERCEPT | B125387 | REGENERON PHARMACEUTICALS

1 product88 Purple Book patents

Biologic LOEProtected

Estimated date when biosimilar competition may begin

May 10, 2042(5790 days remaining)

Regulatory Exclusivities

Type	Expiry	Status	Source
12-Year BPCIA	May. 18, 2024	Expired	Purple Book
7-Year Orphan	Feb. 8, 1930	Expired	Purple Book

Purple Book Patents (88)

Patent	Expiration	Status
11084865	Jun. 14, 2027	Active
11104715	Aug. 18, 2040	Active
D934069	Oct. 26, 2036	Active
11160918	Jul. 29, 2040	Active
11174283	Aug. 18, 2040	Active
11186625	Aug. 18, 2040	Active
11253572	Jan. 11, 2032	Active
11299532	Aug. 18, 2040	Active
11306135	Aug. 18, 2040	Active
11332771	Mar. 14, 2034	Active
D961376	Aug. 23, 2037	Active
D961377	Aug. 23, 2037	Active
11433186	Dec. 12, 2038	Active
11439758	Jun. 4, 2040	Active
11459373	Aug. 18, 2040	Active
11459374	Aug. 18, 2040	Active
11472861	Aug. 18, 2040	Active
11478588	Jul. 25, 2040	Active
11485770	Aug. 18, 2040	Active
11505593	Aug. 18, 2040	Active
11548932	Aug. 18, 2040	Active
11555176	Jan. 27, 2040	Active
10669594	Feb. 12, 2037	Active
11732025	Aug. 18, 2040	Active
7070959	Jun. 16, 2023	Expired
9222106	Jul. 2, 2028	Active
9254338	May. 22, 2032	Active
9669069	Jan. 11, 2032	Active
9816110	Oct. 21, 2035	Active
10130681	Jan. 11, 2032	Active
D858754	Sep. 3, 2034	Active
10406226	Mar. 22, 2026	Expired
10415055	Jun. 4, 2028	Active
10464992	Jun. 14, 2027	Active
11066458	Jun. 14, 2027	Active
10828345	Jan. 11, 2032	Active
10857205	Jan. 11, 2032	Active
10857231	Mar. 14, 2022	Expired
D906102	Dec. 29, 2035	Active
10888601	Jan. 11, 2032	Active
10905786	Mar. 6, 2038	Active
10918754	Mar. 6, 2038	Active
10927342	Aug. 3, 2036	Active
10973879	May. 17, 2039	Active
11053280	Aug. 18, 2040	Active
12054533	Aug. 18, 2040	Active
11918785	Jun. 29, 2037	Active
11970724	Mar. 14, 2034	Active
11975045	Jan. 11, 2032	Active
11986511	Jan. 11, 2032	Active
D1035436	Jul. 16, 2039	Active
D1042107	Sep. 17, 2039	Active
12116622	May. 25, 2038	Active
D1047700	Oct. 22, 2039	Active
12163122	May. 10, 2042	Active
12168036	May. 10, 2039	Active
12202883	Aug. 18, 2040	Active
11577025	Oct. 6, 2037	Active
12221619	Aug. 3, 2036	Active
10961500	Jan. 27, 2040	Active
11286460	Jan. 27, 2040	Active
11649273	Aug. 18, 2040	Active
11821001	Jan. 27, 2040	Active
12077570	Aug. 18, 2040	Active
12268730	Jan. 11, 2032	Active
12282004	Dec. 9, 2041	Active
12280093	May. 17, 2039	Active
11559564	Jan. 11, 2032	Active
11732024	Jun. 14, 2027	Active
11535663	Aug. 18, 2040	Active
11542317	Aug. 18, 2040	Active
11707506	Jan. 11, 2032	Active
11753459	Aug. 18, 2040	Active
11769597	Aug. 15, 2038	Active
11788102	Oct. 21, 2035	Active
11793926	Jul. 29, 2040	Active
7771997	Jul. 2, 2028	Active
9315281	Sep. 16, 2034	Active
9932605	Jun. 4, 2028	Active
10182969	Jul. 13, 2037	Active
11103552	May. 15, 2039	Active
11268109	Oct. 21, 2035	Active
11312936	Aug. 3, 2036	Active
11525833	Nov. 29, 2040	Active
9562238	Jun. 4, 2028	Active
11549154	Dec. 25, 2036	Active
11680930	Oct. 25, 2037	Active
11850407	Sep. 18, 2039	Active

Discovered Patents

View all 251 patents →

Top 50 of 251 AI-discovered patents by relevance.

Composition

(14)

95/1009968674Grant: 2018-05-15 | Exp: 2038-05-10

95/10011576948Grant: 2023-02-14 | Exp: 2043-02-09

95/1007521049Grant: 2009-04-21 | Exp: 2029-04-16

95/1007635474Grant: 2009-12-22 | Exp: 2029-12-17

95/1007399612Grant: 2008-07-15 | Exp: 2028-07-10

95/10011524053Grant: 2022-12-13 | Exp: 2042-12-08

95/1007972598Grant: 2011-07-05 | Exp: 2031-06-30

95/1009708386Grant: 2017-07-18 | Exp: 2037-07-13

95/10011433118Grant: 2022-09-06 | Exp: 2042-09-01

95/1008029791Grant: 2011-10-04 | Exp: 2031-09-29

95/1007704500Grant: 2010-04-27 | Exp: 2030-04-22

95/1007396664Grant: 2008-07-08 | Exp: 2028-07-03

94/10011505593Grant: 2022-11-22 | Exp: 2042-11-17

92/10011306135Grant: 2022-04-19 | Exp: 2042-04-14

Formulation

(18)

98/10012331099Grant: 2025-06-17 | Exp: 2045-06-12

95/10011667702Grant: 2023-06-06 | Exp: 2043-06-01

95/1008481046Grant: 2013-07-09 | Exp: 2033-07-04

95/1009636400Grant: 2017-05-02 | Exp: 2037-04-27

95/10011542317Grant: 2023-01-03 | Exp: 2042-12-29

95/1007608261Grant: 2009-10-27 | Exp: 2029-10-22

95/10010576128Grant: 2020-03-03 | Exp: 2040-02-27

95/1007807164Grant: 2010-10-05 | Exp: 2030-09-30

95/10012178874Grant: 2024-12-31 | Exp: 2044-12-26

94/10011426446Grant: 2022-08-30 | Exp: 2042-08-25

94/1009580489Grant: 2017-02-28 | Exp: 2037-02-23

94/1009982032Grant: 2018-05-29 | Exp: 2038-05-24

94/10012005097Grant: 2024-06-11 | Exp: 2044-06-06

93/1008921316Grant: 2014-12-30 | Exp: 2034-12-25

93/10011135266Grant: 2021-10-05 | Exp: 2041-09-30

93/1007306799Grant: 2007-12-11 | Exp: 2027-12-06

92/1008710004Grant: 2014-04-29 | Exp: 2034-04-24

92/10012168036Grant: 2024-12-17 | Exp: 2044-12-12

Method of Use

(10)

95/10011730794Grant: 2023-08-22 | Exp: 2043-08-17

95/10010888601Grant: 2021-01-12 | Exp: 2041-01-07

95/10010973879Grant: 2021-04-13 | Exp: 2041-04-08

95/10012116622Grant: 2024-10-15 | Exp: 2044-10-10

95/10011596667Grant: 2023-03-07 | Exp: 2043-03-02

95/10011769597Grant: 2023-09-26 | Exp: 2043-09-21

94/10011975045Grant: 2024-05-07 | Exp: 2044-05-02

92/10011944663Grant: 2024-04-02 | Exp: 2044-03-28

92/1007479272Grant: 2009-01-20 | Exp: 2029-01-15

92/10010525104Grant: 2020-01-07 | Exp: 2040-01-02

Manufacturing

(8)

98/10012202883Grant: 2025-01-21 | Exp: 2045-01-16

96/10011732025Grant: 2023-08-22 | Exp: 2043-08-17

95/10012049489Grant: 2024-07-30 | Exp: 2044-07-25

95/10012054533Grant: 2024-08-06 | Exp: 2044-08-01

92/10011649273Grant: 2023-05-16 | Exp: 2043-05-11

92/10011299532Grant: 2022-04-12 | Exp: 2042-04-07

92/10011548932Grant: 2023-01-10 | Exp: 2043-01-05

92/10012012444Grant: 2024-06-18 | Exp: 2044-06-13

PTAB Proceedings

32 challenges on OB patents at the Patent Trial and Appeal Board

Trial #	Patent	Type	Petitioner	Status	Filed	Decision
IPR2021-00402	10464992	IPR	Chengdu Kanghong Biotechnology Co., Ltd. et al.	Terminated	2021-01-07	—
IPR2021-00880	9669069	IPR	Mylan Pharmaceuticals Inc. et al.	Final Written Decision	2021-05-05	2024-07-19
IPR2021-00881	9254338	IPR	Mylan Pharmaceuticals Inc. et al.	Final Written Decision	2021-05-05	2024-07-19
IPR2022-00257	9669069	IPR	Celltrion, Inc. et al.	Final Written Decision	2021-12-09	2024-07-19
IPR2022-00258	9254338	IPR	Celltrion, Inc. et al.	Final Written Decision	2021-12-09	2024-07-19
IPR2022-00298	9254338	IPR	Apotex Inc. et al.	Final Written Decision	2021-12-09	2024-07-19
IPR2022-00301	9669069	IPR	APOTEX INC. et al.	Final Written Decision	2021-12-09	2024-07-19
IPR2022-01225	10130681	IPR	Mylan Pharmaceuticals Inc. et al.	Final Written Decision	2022-07-01	2024-08-23
IPR2022-01226	10888601	IPR	Mylan Pharmaceuticals Inc. et al.	Final Written Decision	2022-07-01	2024-08-23
IPR2022-01524	11253572	IPR	Apotex Inc. et al.	Institution Denied	2022-09-09	2023-03-10
IPR2023-00099	10857205	IPR	Mylan Pharmaceuticals Inc. et al.	Institution Denied	2022-10-28	2023-03-01
IPR2023-00442	10130681	IPR	Samsung Bioepis Co., Ltd.	Final Written Decision	2023-01-06	2024-06-14
IPR2023-00462	10464992	IPR	Celltrion, Inc. et al.	Terminated-Adverse Judgment	2023-01-17	2024-02-21
IPR2023-00532	10130681	IPR	Celltrion, Inc. et al.	Final Written Decision	2023-02-10	2024-08-23
IPR2023-00533	10888601	IPR	Celltrion, Inc. et al.	Final Written Decision	2023-02-10	2024-08-23
IPR2023-00566	10888601	IPR	Samsung Bioepis Co., Ltd.	Final Written Decision	2023-02-10	2024-08-23
IPR2023-00620	10406226	IPR	Celltrion, Inc.	Institution Denied	2023-02-28	2023-09-01
IPR2023-00739	10888601	IPR	Samsung Bioepis Co., Ltd.	Terminated-Adverse Judgment	2023-03-26	2024-07-30
IPR2023-00884	11253572	IPR	Samsung Bioepis Co., Ltd.	Terminated-Adverse Judgment	2023-04-27	2024-07-23
IPR2023-01312	10464992	IPR	Samsung Bioepis Co., Ltd.	Terminated-Adverse Judgment	2023-08-18	2024-02-21
IPR2024-00201	10888601	IPR	Biocon Biologics Inc. et al.	Terminated-Adverse Judgment	2023-11-20	2024-07-30
IPR2024-00260	11253572	IPR	Celltrion, Inc. et al.	Terminated-Adverse Judgment	2023-12-14	2024-07-23
IPR2024-00298	11253572	IPR	Biocon Biologics Inc. et al.	Terminated-Adverse Judgment	2023-12-18	2024-07-23
IPR2025-00176	11084865	IPR	Samsung Bioepis Co., Ltd.	Institution Denied	2024-11-20	2025-06-02
IPR2025-00233	11084865	IPR	Formycon AG	Institution Denied	2024-12-02	2025-06-02
IPR2025-00456	11084865	IPR	Celltrion, Inc.	Discretionary Denial	2025-01-15	2025-06-25
IPR2025-01268	11084865	IPR	Fresenius Kabi SwissBioSim GmbH et al.	Discretionary Denial	2025-07-14	2025-11-20
IPR2025-01269	10828345	IPR	Fresenius Kabi SwissBiosim, GmbH et al.	Institution Denied	2025-07-14	2026-01-09
PGR2021-00035	10828345	PGR	Chengdu Kanghong Biotechnology Co., Ltd. et al.	Terminated	2021-01-07	—
PGR2021-00117	10857231	PGR	Celltrion, Inc. et al.	Institution Denied	2021-09-07	2022-03-15
PGR2025-00085	12168036	PGR	Alvotech USA Inc. et al.	Trial Instituted	2025-09-17	2026-03-03
PGR2026-00039	12168036	PGR	Biocon Biologics Limited et al.	Pending	2026-04-02	—

Patent Reexaminations

2 reexaminations on OB patents from USPTO Patent Center

90/014,449Ex PartePending

Patent: 10406226Filed: 2020-02-11

METHOD OF MANUFACTURING VEGF ANTAGONIST FUSION PROTEINS

Recent Events

2020-03-05RXLITSRLitigation Search Conducted

90/014,448Ex PartePending

Patent: 10464992Filed: 2020-02-11

VEGF ANTAGONIST FORMULATIONS SUITABLE FOR INTRAVITREAL ADMINISTRATION

Recent Events

2023-09-11RXRLFLitigation Found

2023-09-11RXLITSRLitigation Search Conducted

2020-03-03RXLITSRLitigation Search Conducted

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

Hatch-Waxman Litigation

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Regeneron Pharmaceuticals, Inc. v. Amgen Inc. 2:2025cv05499 1 patentaflibercept	C.D. Cal.	2025-06-17	Terminated 2025-07-29	—
Regeneron Pharmaceuticals, Inc. v. Amgen, Inc. 2:2024cv00264 32 patentsaflibercept	C.D. Cal.	2024-01-10	Terminated 2024-04-15	—
Novartis Pharma AG et al v. Regeneron Pharmaceuticals, Inc. 1:2020cv00690 1 patentaflibercept	NYND	2020-06-19	Terminated 2024-11-13	—

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 125387 | 2 presentations | 88 patents

351(a) ReferenceLicensedCDERInjection

Proper Name

aflibercept

Applicant

Regeneron Pharmaceuticals, Inc.

Approval Date

18-Nov-11

First Licensure

18-Nov-11

Orphan Exclusivity

8-Feb-30

Expired

Listed Patents

Patent Number	Expiration
11084865	June 14, 2027
11104715	August 18, 2040
D934069	October 26, 2036
11160918	July 29, 2040
11174283	August 18, 2040
11186625	August 18, 2040
11253572	January 11, 2032
11299532	August 18, 2040
11306135	August 18, 2040
11332771	March 14, 2034
D961376	August 23, 2037
D961377	August 23, 2037
11433186	December 12, 2038
11439758	June 4, 2040
11459373	August 18, 2040
11459374	August 18, 2040
11472861	August 18, 2040
11478588	July 25, 2040
11485770	August 18, 2040
11505593	August 18, 2040
11548932	August 18, 2040
11555176	January 27, 2040
10669594	February 12, 2037
11732025	August 18, 2040
7070959	June 16, 2023
9222106	July 2, 2028
9254338	May 22, 2032
9669069	January 11, 2032
9816110	October 21, 2035
10130681	January 11, 2032
D858754	September 3, 2034
10406226	March 22, 2026
10415055	June 4, 2028
10464992	June 14, 2027
11066458	June 14, 2027
10828345	January 11, 2032
10857205	January 11, 2032
10857231	Disclaimer filed on March 14, 2022
D906102	December 29, 2035
10888601	January 11, 2032
10905786	March 6, 2038
10918754	March 6, 2038
10927342	August 3, 2036
10973879	May 17, 2039
11053280	August 18, 2040
12054533	August 18, 2040
11918785	June 29, 2037
11970724	March 14, 2034
11975045	January 11, 2032
11986511	January 11, 2032
D1035436	July 16, 2039
D1042107	September 17, 2039
12116622	May 25, 2038
D1047700	October 22, 2039
12163122	May 10, 2042
12168036	May 10, 2039
12202883	August 18, 2040
11577025	October 6, 2037
12221619	August 3, 2036
10961500	January 27, 2040
11286460	January 27, 2040
11649273	August 18, 2040
11821001	January 27, 2040
12077570	August 18, 2040
12268730	January 11, 2032
12282004	December 9, 2041
12280093	May 17, 2039
11559564	January 11, 2032
11732024	June 14, 2027
11535663	August 18, 2040
11542317	August 18, 2040
11707506	January 11, 2032
11753459	August 18, 2040
11769597	August 15, 2038
11788102	October 21, 2035
11793926	July 29, 2040
7771997	July 2, 2028
9315281	September 16, 2034
9932605	June 4, 2028
10182969	July 13, 2037
11103552	May 15, 2039
11268109	October 21, 2035
11312936	August 3, 2036
11525833	November 29, 2040
9562238	June 4, 2028
11549154	December 25, 2036
11680930	October 25, 2037
11850407	September 18, 2039

Presentations

2MG/0.05ML — Single-Dose Vial (Intravitreal)

2MG/0.05ML — Pre-Filled Syringe (Intravitreal)

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

Approval Letters

20 letters from Drugs@FDA

Date	Submission	Document
Oct 11, 2024	SUPPL -87	View Letter (PDF)
Dec 15, 2023	SUPPL -84	View Letter (PDF)
Feb 9, 2023	SUPPL -75	View Letter (PDF)
Sep 7, 2022	SUPPL -76	View Letter (PDF)
Mar 31, 2021	SUPPL -69	View Letter (PDF)
May 15, 2019	SUPPL -61	View Letter (PDF)
Aug 20, 2018	SUPPL -58	View Letter (PDF)
Aug 20, 2018	SUPPL -56	View Letter (PDF)
May 31, 2017	SUPPL -54	View Letter (PDF)
Oct 26, 2016	SUPPL -52	View Letter (PDF)
May 25, 2016	SUPPL -51	View Letter (PDF)
Aug 4, 2015	SUPPL -36	View Letter (PDF)
Mar 26, 2015	SUPPL -48	View Letter (PDF)
Oct 8, 2014	SUPPL -43	View Letter (PDF)
Jul 31, 2014	SUPPL -37	View Letter (PDF)
Jan 28, 2014	SUPPL -23	View Letter (PDF)
Jun 11, 2013	SUPPL -15	View Letter (PDF)
Jun 11, 2013	SUPPL -20	View Letter (PDF)
Sep 24, 2012	SUPPL -4	View Letter (PDF)
Nov 22, 2011	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 40MG/ML

▴

INJECTABLE; INJECTION | Approved: 2011-11-18 00:00:00

No patent or exclusivity listings for this strength.