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CETROTIDE Drug Profile

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Which patents cover Cetrotide, and what generic alternatives are available?

Cetrotide is a drug marketed by Emd Serono Inc and is included in one NDA. There is one patent protecting this drug.

This drug has twenty-eight patent family members in twenty-two countries.

The generic ingredient in CETROTIDE is cetrorelix. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the cetrorelix profile page.

US ANDA Litigation and Generic Entry Outlook for Cetrotide

Cetrotide was eligible for patent challenges on August 11, 2004.

Indicators of Generic Entry

Summary for CETROTIDE

International Patents:	28
US Patents:	1
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	58
Clinical Trials:	40
Patent Applications:	3,400
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for CETROTIDE
DailyMed Link:	CETROTIDE at DailyMed

See drug prices for CETROTIDE

Recent Clinical Trials for CETROTIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Oxford Fertility Limited, United Kingdom	Phase 4
University of Oxford	Phase 4
Cairo University	N/A

See all CETROTIDE clinical trials

Synonyms for CETROTIDE

(S)-1-(((R)-2-((S)-2-((S)-2-((R)-2-((R)-2-((R)-2-acetamido-3-(naphthalen-2-yl)propanamido)-3-(4-chlorophenyl)propanamido)-3-(pyridin-3-yl)propanamido)-3-hydroxypropanamido)-3-(4-hyd

120287-85-6

130143-01-0

145672-81-7

1631741-31-5

287C856

ABP000541

ABP000574

Ac-(D-Ala[3-(2-Naphthyl)])-[D-Phe(4-Cl)]-(D-Ala[3-(3-Pyridyl)])-Ser-Tyr-(D-Cit)-Leu-Arg-Pro-D-Ala-Oh

AC-28734

Ac-D-Nal(2)-D-Phe(pCl)-D-Pal(3)-Ser-Tyr-D-Cit-Leu-Arg-Pro-D-Ala-NH2

AKOS015994648

AKOS024457671

BDBM50369965

C-35500

C70H92ClN17O14

Cetrelix Acetate

Cetrorelix

Cetrorelix (Acetate)

Cetrorelix (INN)

Cetrorelix [INN:BAN]

Cetrorelix acetate

Cetrorelix acetate (JAN/USAN)

Cetrorelix acetate, >=98% (HPLC)

Cetrorelix Acetate(Cetrotide)/

Cetrorelix monoacetate

Cetrorelix(Cetrorelix acetate)

Cetrorelixum

Cetrorelixum [INN-Latin]

Cetrotide (TN)

CHEBI:31387

CHEBI:59224

CHEMBL1200490

CHEMBL2103735

CS-5843

D-20453

D-20761

D-Alaninamide, N-acetyl-3-(2-naphthalenyl)-D-alanyl-4-chloro-D-phenylalanyl-3-(3-pyridinyl)-D-alanyl-L-seryl-L-tyrosyl-N5-(aminocarbonyl)-D-ornithyl-L-leucyl-L-arginyl-L-prolyl-, acetate (1:1)

D01685

D07665

DB00050

DTXSID7040996

FT-0647968

FT-0656251

GTPL1190

HS-2008

HSDB 7696

HY-P0009A

KS-00002WUP

MFCD08459466

MolPort-009-194-176

MolPort-042-652-596

N-acetyl-3-(2-naphthalenyl)-D-alanyl-4-chloro-D-phenylalanyl-3-(3-pyridinyl)-D-alanyl-L-seryl-L-tyrosyl-N5-(aminocarbonyl)-D-ornithyl-L-leucyl-L-arginyl-L-prolyl-D-alaninamide acetic acid salt

N-acetyl-3-(2-naphthyl)-D-alanyl-4-chloro-D-phenylalanyl-3-(3-pyridyl)-D-alanyl-L-seryl-L-tyrosyl-N5-carbomoyl-D-ornithyl-L-leucyl-L-prolyl-D-alaninamide

N-Acetyl-3-(2-naphthyl)-D-alanyl-p-chloro-D-phenylalanyl-3-(3-pyridyl)-D-alanyl-L-seryl-L-tyrosyl-N(sup 5)-carbamoyl-D-ornithyl-L-leucyl-L-arginyl-L-prolyl-D-alaninamide

N-acetyl-3-(naphthalen-2-yl)-D-alanyl-4-chloro-D-phenylalanyl-3-(pyridin-3-yl)-D-alanyl-L-seryl-L-tyrosyl-N(5)-carbamoyl-D-ornithyl-L-leucyl-L-arginyl-L-prolyl-D-alaninamide

N-acetyl-3-(naphthalen-2-yl)-D-alanyl-4-chloro-D-phenylalanyl-3-(pyridin-3-yl)-D-alanyl-L-seryl-L-tyrosyl-N(5)-carbamoyl-D-ornithyl-L-leucyl-L-arginyl-L-prolyl-D-alaninamide acetate

NCGC00485296-01

NS-75A

NS-75B

OON1HFZ4BA

roxyphenyl)propanamido)-5-ureidopentanoyl)-L-leucyl-L-arginyl)-N-((R)-1-amino-1-oxopropan-2-yl)pyrrolidine-2-carboxamide

SB 75

SB-075

SB-075 ACETATE

SB-75

SC-50568

SC-82639

SCHEMBL19712202

SCHEMBL19712228

SCHEMBL61331

SCHEMBL61332

UNII-OON1HFZ4BA

UNII-XPQ226310Q

V0412

XPQ226310Q

Y-100040

US Patents and Regulatory Information for CETROTIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Emd Serono Inc	CETROTIDE	cetrorelix	INJECTABLE;INJECTION	021197-001	Aug 11, 2000		RX	Yes	Yes
Emd Serono Inc	CETROTIDE	cetrorelix	INJECTABLE;INJECTION	021197-002	Aug 11, 2000		DISCN	No	No

Expired US Patents for CETROTIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Emd Serono Inc	CETROTIDE	cetrorelix	INJECTABLE;INJECTION	021197-002	Aug 11, 2000
Emd Serono Inc	CETROTIDE	cetrorelix	INJECTABLE;INJECTION	021197-001	Aug 11, 2000
Emd Serono Inc	CETROTIDE	cetrorelix	INJECTABLE;INJECTION	021197-001	Aug 11, 2000
Emd Serono Inc	CETROTIDE	cetrorelix	INJECTABLE;INJECTION	021197-002	Aug 11, 2000
Emd Serono Inc	CETROTIDE	cetrorelix	INJECTABLE;INJECTION	021197-001	Aug 11, 2000
Emd Serono Inc	CETROTIDE	cetrorelix	INJECTABLE;INJECTION	021197-002	Aug 11, 2000
Emd Serono Inc	CETROTIDE	cetrorelix	INJECTABLE;INJECTION	021197-002	Aug 11, 2000

International Patents for CETROTIDE

Country	Patent Number	Estimated Expiration
Slovenia	1082129
Australia	3702899
World Intellectual Property Organization (WIPO)	9955357
Slovakia	285192
Denmark	1082129
Ukraine	66850
Poland	343609

Supplementary Protection Certificates for CETROTIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0299402	099C0031	Belgium		PRODUCT NAME: ACETATE DE CETRORELIX; REGISTRATION NO/DATE: EU/1/99/100/001 19990413
0299402	C990029	Netherlands		PRODUCT NAME: CETRORELIX, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAAR DBAAR ZUUR ADDITIEZOUT, IN HET BIJZONDER CETRORELIX ACETAAT; REGISTRATION NO/DATE: EU/1/99/100/001-003 19990413
0299402	31/1999	Austria		PRODUCT NAME: CETRORELIX UND PHARMAZEUTISCH ANNEHMBARE SAEUREADDITIONSSALZE DAVON, INSBESONDERE CETRORELIXACETAT; REGISTRATION NO/DATE: EU/1/99/100/001- EU/1/99/100/003 19990413