The patent has been granted The patent has been granted, Grant of patent is intended, Examination is in progress, Request for examination was made, The application has been published EP Register Verified

MANUFACTURE OF DEGARELIX

Publication No. EP4512389

•

App No. EP25151066

•

Filed by Ferring B.V.

•

Filed on 2013-05-31

•

Issued/Published on 2026-02-04

Official EPO Register

Publication No. EP4512389 A2

Application No. EP25151066 Filed: 2013-05-31

Grant Date 2026-02-04 Mention of grant

Active Oppositions 1 Active EPO Oppositions

Patent Abstract / Summary

The present invention provides methods for producing a lyophilized degarelix product which, upon reconstitution with water for injection in an amount of 20 mg/ml, shows a viscosity of up to 15 mPas.The present invention also provides a lyophilized degarelix drug substance which shows, upon dissolution in water in an amount of 20 mg/ml, a viscosity of up to 3.2 mPas, and processes for providing this lyophilized degarelix drug substance.

IPC Classifications

A61K38/09, A61K47/12, A61K9/19 A61K9/00

Priority Claims

EP 20120170454 Date: 2012-06-01

Designated Contracting States (38 EPC States)

AL AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MK MT NL NO PL PT RO RS SE SI SK SM TR

Parties & Representation

Applicants

Ferring B.V.

Polaris Avenue 144, 2132 JX Hoofddorp

Inventors (8)

SCHWACH, Grégoire

DK-1610 Copenhagen

NILSSON, Anders

S-226 50 Lund

GOTTSCHALK BOEVING, Tine Elisabeth

DK-2800 Lyngby

RASMUSSEN, Jon Holbech

DK-2800 Lyngby

MÖRNSTAM, Birgitta

S-216 11 Limham

TSIRK, Anders

S-211 56 Malmö

ANNBY, Ulf

S-22 477 Lund

FOMSGAARD, Jens

DK-3520 Farum

Representatives / Agents

Reddie & Grose LLP

The White Chapel Building, 10 Whitechapel High Street

Brand Murray Fuller LLP

First Floor, 111 Wardour Street, London W1F 0UH

Key Procedural Dates

Request-For-Examination 2025-07-22

Mention Of Grant Published 2026-02-04

First-Examination-Report-Despatched 2025-09-25

Patent Oppositions

Official opposition proceedings filed against European Patent EP4512389 under EPC Article 99.

1 ACTIVE OPPONENT

Opponent Company

Accord Healthcare S.L.U.

World Trade Center, ES

Representative

Brand Murray Fuller LLP

Filing Date

2026-06-01

Opposition in Progress

Legal Status & Event History

Official European Patent Office legal and procedural status changes recorded for this file.

55 Events Recorded

Date	Code	Event Description	Auth
2025-01-24	PUAI	PUBLIC REFERENCE MADE UNDER ARTICLE 153(3) EPC TO A PUBLISHED INTERNATIONAL APPLICATION THAT HAS ENTERED THE EUROPEAN PHASE	EP
2025-01-24	STAA	INFORMATION ON THE STATUS OF AN EP PATENT APPLICATION OR GRANTED EP PATENT	EP
2025-02-26	AC	DIVISIONAL APPLICATION: REFERENCE TO EARLIER APPLICATION	EP
2025-02-26	AK	DESIGNATED CONTRACTING STATES	EP
2025-05-16	PUAL	SEARCH REPORT DESPATCHED	EP
2025-05-09	REG	REFERENCE TO A NATIONAL CODE	EP
2025-06-18	RIC1	INFORMATION PROVIDED ON IPC CODE ASSIGNED BEFORE GRANT	EP
2025-06-18	AK	DESIGNATED CONTRACTING STATES	EP
2025-07-30	RAP3	PARTY DATA CHANGED (APPLICANT DATA CHANGED OR RIGHTS OF AN APPLICATION TRANSFERRED)	EP
2025-07-25	STAA	INFORMATION ON THE STATUS OF AN EP PATENT APPLICATION OR GRANTED EP PATENT	EP
2025-08-27	17P	REQUEST FOR EXAMINATION FILED	EP
2025-09-15	REG	REFERENCE TO A NATIONAL CODE	EP
2025-09-25	REG	REFERENCE TO A NATIONAL CODE	EP
2025-09-30	REG	REFERENCE TO A NATIONAL CODE	EP
2025-09-26	REG	REFERENCE TO A NATIONAL CODE	EP
2025-09-26	STAA	INFORMATION ON THE STATUS OF AN EP PATENT APPLICATION OR GRANTED EP PATENT	EP
2025-10-15	P01	OPT-OUT OF THE COMPETENCE OF THE UNIFIED PATENT COURT (UPC) REGISTERED	EP
2025-10-29	17Q	FIRST EXAMINATION REPORT DESPATCHED	EP
2025-11-14	REG	REFERENCE TO A NATIONAL CODE	EP
2025-12-20	GRAS	GRANT FEE PAID	EP
2025-12-18	GRAP	DESPATCH OF COMMUNICATION OF INTENTION TO GRANT A PATENT	EP
2025-12-18	STAA	INFORMATION ON THE STATUS OF AN EP PATENT APPLICATION OR GRANTED EP PATENT	EP
2026-01-14	REG	REFERENCE TO A NATIONAL CODE	EP
2026-01-01	GRAA	(EXPECTED) GRANT	EP
2026-01-01	STAA	INFORMATION ON THE STATUS OF AN EP PATENT APPLICATION OR GRANTED EP PATENT	EP
2026-01-21	INTG	INTENTION TO GRANT ANNOUNCED	EP
2026-02-04	AC	DIVISIONAL APPLICATION: REFERENCE TO EARLIER APPLICATION	EP
2026-02-04	AK	DESIGNATED CONTRACTING STATES	EP
2026-02-04	REG	REFERENCE TO A NATIONAL CODE	EP
2026-02-19	REG	REFERENCE TO A NATIONAL CODE	EP
2026-02-25	REG	REFERENCE TO A NATIONAL CODE	EP
2026-04-01	U01	REQUEST FOR UNITARY EFFECT FILED	EP
2026-04-01	U07	UNITARY EFFECT REGISTERED	EP
2026-04-08	P04	WITHDRAWAL OF OPT-OUT OF THE COMPETENCE OF THE UNIFIED PATENT COURT (UPC) REGISTERED	EP
2013-05-31	REG	REFERENCE TO A NATIONAL CODE	EP
2026-05-13	REG	REFERENCE TO A NATIONAL CODE	EP
2026-05-27	U76	LICENCE FOR THE EUROPEAN PATENT WITH UNITARY EFFECT REGISTERED	EP
2026-06-01	REG	REFERENCE TO A NATIONAL CODE	EP
2026-06-05	PLBI	OPPOSITION FILED	EP
2026-05-22	REG	REFERENCE TO A NATIONAL CODE	EP
2026-06-11	REG	REFERENCE TO A NATIONAL CODE	EP
2026-06-05	REG	REFERENCE TO A NATIONAL CODE	EP
2026-06-24	U20	RENEWAL FEE FOR THE EUROPEAN PATENT WITH UNITARY EFFECT PAID	EP
2026-06-29	REG	REFERENCE TO A NATIONAL CODE	EP
2026-07-08	26	OPPOSITION FILED	EP
2026-07-08	PGFP	ANNUAL FEE PAID TO NATIONAL OFFICE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NATIONAL OFFICE TO EPO]	EP
2026-07-09	PGFP	ANNUAL FEE PAID TO NATIONAL OFFICE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NATIONAL OFFICE TO EPO]	EP
2026-07-10	PGFP	ANNUAL FEE PAID TO NATIONAL OFFICE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NATIONAL OFFICE TO EPO]	EP
2026-07-14	PGFP	ANNUAL FEE PAID TO NATIONAL OFFICE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NATIONAL OFFICE TO EPO]	EP
2026-07-16	PGFP	ANNUAL FEE PAID TO NATIONAL OFFICE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NATIONAL OFFICE TO EPO]	EP
2026-07-17	PGFP	ANNUAL FEE PAID TO NATIONAL OFFICE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NATIONAL OFFICE TO EPO]	EP
2026-07-18	PGFP	ANNUAL FEE PAID TO NATIONAL OFFICE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NATIONAL OFFICE TO EPO]	EP
2026-07-21	PGFP	ANNUAL FEE PAID TO NATIONAL OFFICE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NATIONAL OFFICE TO EPO]	EP
2026-07-25	PGFP	ANNUAL FEE PAID TO NATIONAL OFFICE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NATIONAL OFFICE TO EPO]	EP
2026-10-06	PG25	LAPSED IN A CONTRACTING STATE [ANNOUNCED VIA POSTGRANT INFORMATION FROM NATIONAL OFFICE TO EPO]	EP

Patent & Non-Patent Citations

Cited documents and prior art referenced in search and examination reports.

15 Citations

Cited Patent Documents

WO2009846634

Espacenet

WO9846634

Espacenet

WO2010012835

Espacenet

WO2011066386

Espacenet

WO2012055905

Espacenet

WO2012055903

Espacenet

CN102204889 2011-10-05

Espacenet

WO2011004260 2011-01-13

Espacenet

WO2010125468 2010-11-04

Espacenet

US2005282731 2005-12-22

Espacenet

Non-Patent Scientific Literature (NPL)

- DOEHN ET AL., DRUGS, vol. 9, no. 8, 2006, pages 565 - 571

- VAN POPPEL, CANCER MANAGEMENT AND RESEARCH, vol. 2, 2010, pages 39 - 52

- VAN POPPEL ET AL., UROLOGY, vol. 71, no. 6, 2008, pages 1001 - 1006

- JAMES, E.F. ET AL., DRUGS, vol. 69, no. 14, 2009, pages 1967 - 1976

- JIANG ET AL., J. MED. CHEM., vol. 44, no. 214766-78-6, 2001, pages 453 - 467

Worldwide Patent Family

Related applications and patents in the same INPADOC worldwide family.

78 Family Members

Country	Publication Number	Kind	Publication Date	Action
EP	EP4512389A2	A2	2025-02-26	Espacenet
EP	EP4512389A3	A3	2025-06-18	Espacenet
EP	EP4512389B1	B1	2026-02-04	Espacenet
EP	EP4512389C0	C0	2026-02-04	Espacenet
AR	AR092840A1	A1	2015-05-06	Espacenet
AR	AR123619A2	A2	2022-12-21	Espacenet
AU	AU2013269523A1	A1	2015-01-15	Espacenet
AU	AU2013269523B2	B2	2017-09-28	Espacenet
BR	BR112014029495A2	A2	2017-06-27	Espacenet
CA	CA2874927A1	A1	2013-12-05	Espacenet
CA	CA3228586A1	A1	2013-12-05	Espacenet
CN	CN104334182A	A	2015-02-04	Espacenet
CN	CN104334182B	B	2017-09-08	Espacenet
CN	CN107569456A	A	2018-01-12	Espacenet
DE	DE25151066T1	T1	2025-09-25	Espacenet
DE	DE25151068T1	T1	2025-10-02	Espacenet
DK	DK2854831T3	T3	2024-10-14	Espacenet
EP	EP2854831A2	A2	2015-04-08	Espacenet
EP	EP2854831B1	B1	2024-07-10	Espacenet
EP	EP4385517A2	A2	2024-06-19	Espacenet
EP	EP4385517A3	A3	2024-11-13	Espacenet
EP	EP4512390A2	A2	2025-02-26	Espacenet
EP	EP4512390A3	A3	2025-06-25	Espacenet
EP	EP4512390B1	B1	2026-01-28	Espacenet
EP	EP4512390C0	C0	2026-01-28	Espacenet
ES	ES2988481T3	T3	2024-11-20	Espacenet
ES	ES3037194T1	T1	2025-09-30	Espacenet
ES	ES3037194T3	T3	2026-05-13	Espacenet
ES	ES3037257T1	T1	2025-09-30	Espacenet
ES	ES3037257T3	T3	2026-05-14	Espacenet
FI	FI2854831T3	T3	2024-10-15	Espacenet
FI	FI4512389T1	T1	2025-08-01	Espacenet
FI	FI4512390T1	T1	2025-08-01	Espacenet
HK	HK1209046A1	A1	2016-03-24	Espacenet
HR	HRP20241284T1	T1	2024-12-06	Espacenet
HR	HRP20260331T1	T1	2026-04-10	Espacenet
HR	HRP20260500T1	T1	2026-05-22	Espacenet
HU	HUE068579T2	T2	2025-01-28	Espacenet
IL	IL235856B	B	2018-12-31	Espacenet
JO	JO3586B1	B1	2020-07-05	Espacenet
JP	JP2015518866A	A	2015-07-06	Espacenet
JP	JP6226966B2	B2	2017-11-08	Espacenet
KR	KR20150022854A	A	2015-03-04	Espacenet
KR	KR102140982B1	B1	2020-08-05	Espacenet
LT	LT2854831T	T	2024-10-10	Espacenet
MX	MX2014014662A	A	2015-02-24	Espacenet
MX	MX364010B	B	2019-04-11	Espacenet
MY	MY182320A	A	2021-01-19	Espacenet
NZ	NZ701978A	A	2016-12-23	Espacenet
NZ	NZ727679A	A	2018-05-25	Espacenet
PH	PH12014502682A1	A1	2015-01-26	Espacenet
PH	PH12014502682B1	B1	2015-01-26	Espacenet
PL	PL2854831T3	T3	2024-11-25	Espacenet
PL	PL4512389T1	T1	2025-09-01	Espacenet
PL	PL4512389T3	T3	2026-05-25	Espacenet
PL	PL4512390T1	T1	2025-09-01	Espacenet
PL	PL4512390T3	T3	2026-05-18	Espacenet
RS	RS66065B1	B1	2024-11-29	Espacenet
RS	RS67929B1	B1	2026-04-30	Espacenet
RS	RS67932B1	B1	2026-04-30	Espacenet
RU	RU2014146272A	A	2016-07-27	Espacenet
RU	RU2657444C2	C2	2018-06-13	Espacenet
SG	SG11201407679PA	A	2014-12-30	Espacenet
SI	SI2854831T1	T1	2024-11-29	Espacenet
TW	TW201400143A	A	2014-01-01	Espacenet
TW	TWI580443B	B	2017-05-01	Espacenet
US	US2017319644A1	A1	2017-11-09	Espacenet
US	US10172906B2	B2	2019-01-08	Espacenet
US	US2019224271A1	A1	2019-07-25	Espacenet
US	US10765721B2	B2	2020-09-08	Espacenet
US	US2021077564A1	A1	2021-03-18	Espacenet
US	US11260102B2	B2	2022-03-01	Espacenet
US	US2021138024A1	A1	2021-05-13	Espacenet
US	US11510962B2	B2	2022-11-29	Espacenet
US	US2015141337A1	A1	2015-05-21	Espacenet
US	US9592266B2	B2	2017-03-14	Espacenet
WO	WO2013178788A2	A2	2013-12-05	Espacenet
WO	WO2013178788A3	A3	2014-02-27	Espacenet

Official File Inspection EPC Art. 128 Public Dossier

Complete European Patent Register Dossier (148 Total Documents)

The full inspection file for Application EP25151066 contains 148 total documents, including all notices of opposition, proprietor counter-statements, examination communications, third-party observations, and procedural forms. Below are all major recorded procedural filings and publication specifications.

Open 148-Doc Register Dossier

Dossier Filing

Date: 2025-12-18 Procedure: Grant EPIDOSNIGR1

Inspect on Register

MANUFACTURE OF DEGARELIX

Patent Abstract / Summary

IPC Classifications

Priority Claims

Designated Contracting States (38 EPC States)

Parties & Representation

Applicants

Inventors (8)

Representatives / Agents

Key Procedural Dates

Patent Oppositions

Accord Healthcare S.L.U.

Legal Status & Event History

Patent & Non-Patent Citations

Cited Patent Documents

Non-Patent Scientific Literature (NPL)

Worldwide Patent Family

Complete European Patent Register Dossier (148 Total Documents)

Recorded Filings & Patent Specifications

European Patent Specification - Granted Patent (B1)

Official European Patent Register Full Dossier

European Search Report (A3)

European Patent Application without Search Report (A2)

Lapse of the patent in a contracting state

Opposition filed

(Expected) grant

New entry: Payment of fee for grant

New entry: Payment of fee for publishing/printing

New entry: Receipt of the translation of the claim(s)

Change - English title

New entry: Communication of intention to grant a patent

Intention to grant the patent

New entry: Reply to examination report

First examination report

Communication from the examining division

The date on which the examining division becomes responsible, has been established

Request for examination filed

Date on which the examining division has become responsible

Amendment by applicant

Amendments

Change - applicant

New entry: Renewal fee paid

Renewal fee payment

Change - classification

Publication of search report

Publication in section I.1 EP Bulletin

New entry: Renewal fee paid

Change - representative

Renewal fee payment

Language of the procedure

International searching authority

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