ZOLADEX Drug Patent 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.

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

Summary for ZOLADEX

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	45
Clinical Trials:	153
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ZOLADEX
What excipients (inactive ingredients) are in ZOLADEX?	ZOLADEX excipients list
DailyMed Link:	ZOLADEX at DailyMed

Drug patent expirations by year for ZOLADEX

Recent Clinical Trials for ZOLADEX

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

Sponsor	Phase
Novartis Pharmaceuticals	Phase 1
Women's Hospital School Of Medicine Zhejiang University	N/A
Eli Lilly and Company	Phase 1/Phase 2

See all ZOLADEX clinical trials

Pharmacology for ZOLADEX

Drug Class	Gonadotropin Releasing Hormone Receptor Agonist
Mechanism of Action	Gonadotropin Releasing Hormone Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for ZOLADEX

L02AE	Gonadotropin releasing hormone analogues
L02A	HORMONES AND RELATED AGENTS
L02	ENDOCRINE THERAPY
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for ZOLADEX

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Tersera	ZOLADEX	goserelin acetate	IMPLANT;IMPLANTATION	020578-001	Jan 11, 1996		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a 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

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

International Patents for ZOLADEX

See the table below for patents covering ZOLADEX around the world.

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Country	Patent Number	Title	Estimated Expiration
Czech Republic	20022829		⤷ Try a Trial
Portugal	74434	CONTINUOUS RELEASE PHARMACEUTICAL COMPOSITIONS	⤷ Try a Trial
Norway	820433		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Summary for ZOLADEX

Recent Clinical Trials for ZOLADEX

Pharmacology for ZOLADEX

Anatomical Therapeutic Chemical (ATC) Classes for ZOLADEX

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