Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: October 22, 2019

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GOSERELIN ACETATE - Generic Drug Details

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What are the generic drug sources for goserelin acetate and what is the scope of freedom to operate?

Goserelin acetate is the generic ingredient in one branded drug marketed by Tersera Theraps Llc and is included in two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Goserelin acetate has fifty patent family members in thirty-three countries.

There are five drug master file entries for goserelin acetate. Three suppliers are listed for this compound.

Summary for GOSERELIN ACETATE
Recent Clinical Trials for GOSERELIN ACETATE

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

SponsorPhase
Merck Sharp & Dohme Corp.Phase 2
TerSera TherapeuticsPhase 2
Big Ten Cancer Research ConsortiumPhase 2

See all GOSERELIN ACETATE clinical trials

Pharmacology for GOSERELIN ACETATE
Medical Subject Heading (MeSH) Categories for GOSERELIN ACETATE
Synonyms for GOSERELIN ACETATE
[D-Ser(tBu)6,Azagly10]-LHRH acetate salt
0F65R8P09N
1-(5-Oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-O-tert-butyl-D-seryl-L-leucyl-L-arginyl-L-prolyl)semicarbazide
1-9-Luteinizing hormone-releasing factor (swine), 6-(O-(1,1-dimethylethyl)-D-serine)-, 2-(aminocarbonyl)hydrazide, acetate (salt)
145781-92-6
4-D-Ser-goserelin
6-[O-(1,1-Dimethylethyl)-D-serine]-1-9-luteinizing Hormone-releasing Factor (swine) 2-(Aminocarbonyl)hydrazide Acetate
6-[O-(1,1-Dimethylethyl)-D-serine]-1-9-luteinizing Hormone-releasing Factor (swine) 2-(Aminocarbonyl)hydrazide Acetate Deuterated
65807-02-5
6YUU2PV0U8
70280-59-0
781G926
807G025
81G926
AB01275466-01
AC1NSK1T
AKOS015994653
AKOS030213245
B3723
CAS-145781-92-6
CG-048
CHEBI:5523
CHEMBL1200501
CHEMBL1201247
CS-3114
CS-4509
D-Ser(But)6Azgly10-gonadorelin
D-Ser(But)6Azgly10-gonadorelin Deuterated
D-Ser(But)6Azgly10LHRH
D-Ser(t-Bu)(sup 6)aza-gly(sup 10)-GNRH
D00573
D04405
DB00014
Decapeptide I
DSSTox_CID_26736
DSSTox_GSID_46736
DSSTox_RID_81865
DTXSID7048297
DTXSID9046736
Fertilan
Fertilan Deuterated
goserelin
Goserelin (acetate)
Goserelin (USAN/INN)
Goserelin [USAN:INN:BAN]
Goserelin acetate (JAN/USP)
Goserelin acetate [JAN]
Goserelin acetate, >=99% (HPLC), white powder
Goserelin acetate, United States Pharmacopeia (USP) Reference Standard
Goserelin Deuterated Acetate
Goserelin for NMR identification, European Pharmacopoeia (EP) Reference Standard
Goserelin, European Pharmacopoeia (EP) Reference Standard
Goserelina
Goserelina [Spanish]
Gosereline
Gosereline [French]
Goserelinum
Goserelinum [Latin]
GTPL3879
HMS2089D16
HS-2015
HSDB 7606
HY-13673
HY-13673A
ICI 118,630
ICI 118630
ICI-118630
IKDXDQDKCZPQSZ-JHYYTBFNSA-N
KS-00002WUS
Luteinizing hormone-releasing factor (pig), 6-(O-(1,1-dimethylethyl)-D-serine)-10-deglycinamide-, 2-(aminocarbonyl)hydrazide
MFCD01747329
MolPort-006-823-831
MolPort-046-033-629
NCGC00167588-02
NCGC00183275-01
SCHEMBL19712239
SCHEMBL20459194
SCHEMBL6094
SCHEMBL8643
Tox21_112579
Tox21_112937
UNII-0F65R8P09N
UNII-6YUU2PV0U8
ZD-9393
Zoladex
Zoladex (TN)

US Patents and Regulatory Information for GOSERELIN ACETATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Tersera Theraps Llc ZOLADEX goserelin acetate IMPLANT;IMPLANTATION 020578-001 Jan 11, 1996 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Tersera Theraps Llc ZOLADEX goserelin acetate IMPLANT;IMPLANTATION 019726-001 Dec 29, 1989 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Tersera Theraps Llc ZOLADEX goserelin acetate IMPLANT;IMPLANTATION 020578-001 Jan 11, 1996 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Tersera Theraps Llc ZOLADEX goserelin acetate IMPLANT;IMPLANTATION 019726-001 Dec 29, 1989 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Tersera Theraps Llc ZOLADEX goserelin acetate IMPLANT;IMPLANTATION 019726-001 Dec 29, 1989 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for GOSERELIN ACETATE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Tersera Theraps Llc ZOLADEX goserelin acetate IMPLANT;IMPLANTATION 019726-001 Dec 29, 1989   Start Trial   Start Trial
Tersera Theraps Llc ZOLADEX goserelin acetate IMPLANT;IMPLANTATION 020578-001 Jan 11, 1996   Start Trial   Start Trial
Tersera Theraps Llc ZOLADEX goserelin acetate IMPLANT;IMPLANTATION 020578-001 Jan 11, 1996   Start Trial   Start Trial
Tersera Theraps Llc ZOLADEX goserelin acetate IMPLANT;IMPLANTATION 019726-001 Dec 29, 1989   Start Trial   Start Trial
Tersera Theraps Llc ZOLADEX goserelin acetate IMPLANT;IMPLANTATION 020578-001 Jan 11, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Baxter
Express Scripts
Medtronic
Boehringer Ingelheim
Johnson and Johnson

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