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Last Updated: November 29, 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 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. Two 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.

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
ECOG-ACRIN Cancer Research GroupPhase 3
Luye Pharma Group Ltd.Phase 3
Xiao X. WeiPhase 2

See all ZOLADEX clinical trials

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 ZOLADEX goserelin acetate IMPLANT;IMPLANTATION 019726-001 Dec 29, 1989 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Tersera ZOLADEX goserelin acetate IMPLANT;IMPLANTATION 020578-001 Jan 11, 1996 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Tersera ZOLADEX goserelin acetate IMPLANT;IMPLANTATION 019726-001 Dec 29, 1989 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Tersera ZOLADEX goserelin acetate IMPLANT;IMPLANTATION 019726-001 Dec 29, 1989 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Tersera ZOLADEX goserelin acetate IMPLANT;IMPLANTATION 020578-001 Jan 11, 1996 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Tersera 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 ZOLADEX goserelin acetate IMPLANT;IMPLANTATION 020578-001 Jan 11, 1996   Start Trial   Start Trial
Tersera ZOLADEX goserelin acetate IMPLANT;IMPLANTATION 020578-001 Jan 11, 1996   Start Trial   Start Trial
Tersera ZOLADEX goserelin acetate IMPLANT;IMPLANTATION 019726-001 Dec 29, 1989   Start Trial   Start Trial
Tersera ZOLADEX goserelin acetate IMPLANT;IMPLANTATION 020578-001 Jan 11, 1996   Start Trial   Start Trial
Tersera 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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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 verification 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.