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Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
Argus Health
Farmers Insurance
Fish and Richardson
Chinese Patent Office

Generated: June 25, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020578

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NDA 020578 describes ZOLADEX, which is a drug marketed by Tersera Theraps Llc and is included in two NDAs. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the ZOLADEX profile page.

The generic ingredient in ZOLADEX is goserelin acetate. There are three 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 NDA: 020578

Therapeutic Class:Hormonal Agents, Suppressant (Pituitary)
Formulation / Manufacturing:see details

Pharmacology for NDA: 020578

Suppliers and Packaging for NDA: 020578

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
goserelin acetate
IMPLANT;IMPLANTATION 020578 NDA AstraZeneca Pharmaceuticals LP 0310-0951 0310-0951-30 1 POUCH in 1 CARTON (0310-0951-30) > 1 SYRINGE in 1 POUCH > 1 IMPLANT in 1 SYRINGE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:IMPLANT;IMPLANTATIONStrengthEQ 10.8MG BASE
Approval Date:Jan 11, 1996TE:RLD:Yes
Patent:7,118,552Patent Expiration:Apr 13, 2022Product Flag?YSubstance Flag?Delist Request?
Patent:7,220,247Patent Expiration:Apr 9, 2022Product Flag?YSubstance Flag?Delist Request?
Patent:7,500,964Patent Expiration:Feb 26, 2021Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 020578

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Tersera Theraps Llc
goserelin acetate
IMPLANT;IMPLANTATION020578-001Jan 11, 19964,767,628► Subscribe
Tersera Theraps Llc
goserelin acetate
IMPLANT;IMPLANTATION020578-001Jan 11, 19965,366,734► Subscribe
Tersera Theraps Llc
goserelin acetate
IMPLANT;IMPLANTATION020578-001Jan 11, 19964,100,274► Subscribe
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Serving 500+ biopharmaceutical companies globally:

US Department of Justice
Boehringer Ingelheim

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