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Last Updated: February 19, 2020

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ZOLADEX Drug Profile


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Which patents cover Zoladex, and when can generic versions of Zoladex launch?

Zoladex is a drug marketed by Tersera Theraps Llc and is included in two NDAs. There are three patents protecting this drug.

This drug has fifty patent family members in thirty-three countries.

The generic ingredient in ZOLADEX is goserelin acetate. There are five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the goserelin acetate profile page.

US ANDA Litigation and Generic Entry Outlook for Zoladex

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be April 13, 2022. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for ZOLADEX
Drug Prices for ZOLADEX

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Generic Entry Opportunity Date for ZOLADEX
Generic Entry Dates for ZOLADEX*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
IMPLANT;IMPLANTATION
Generic Entry Dates for ZOLADEX*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
IMPLANT;IMPLANTATION

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ZOLADEX

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

SponsorPhase
Xiao X. WeiPhase 2
Eurofarma Laboratorios S.A.Phase 3
University of California, San DiegoEarly Phase 1

See all ZOLADEX clinical trials

Recent Litigation for ZOLADEX

Identify potential future generic entrants

District Court Litigation
Case NameDate
ADAMAS PHARMA, LLC v. SANDOZ INC.2018-05-10

See all ZOLADEX litigation

Synonyms for ZOLADEX
[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
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
70280-59-0
807G025
81G926
AB01275466-01
AC1NSK1T
AKOS015994653
AKOS030213245
B3723
CHEBI:5523
CHEMBL1201247
CS-3114
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
D04405
DB00014
Decapeptide I
DTXSID7048297
Fertilan
Fertilan Deuterated
goserelin
Goserelin (USAN/INN)
Goserelin [USAN:INN:BAN]
Goserelin acetate
Goserelin Deuterated Acetate
Goserelina
Goserelina [Spanish]
Gosereline
Gosereline [French]
Goserelinum
Goserelinum [Latin]
GTPL3879
HMS2089D16
HS-2015
HSDB 7606
HY-13673
ICI 118,630
ICI 118630
ICI-118630
KS-00002WUS
Luteinizing hormone-releasing factor (pig), 6-(O-(1,1-dimethylethyl)-D-serine)-10-deglycinamide-, 2-(aminocarbonyl)hydrazide
MFCD01747329
MolPort-006-823-831
SCHEMBL19712239
SCHEMBL20459194
SCHEMBL8643
UNII-0F65R8P09N
ZD-9393

US Patents and Regulatory Information for ZOLADEX

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 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
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 020578-001 Jan 11, 1996 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 ZOLADEX

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 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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Dow
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Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.