Herceptin - (21mg/mL; Vial, Intravenous)

Generic Name	Trastuzumab	Innovator	Genentech, Inc.
Dosage	21mg/mL; Vial, Intravenous	Branded US Sales	More Than $1000 mn
Probable FTF	None	Known Para IV Filers	More Than 5
Other ANDA developers	More Than 5	Tentative Approvals	None
Final Approvals	More Than 5	Generic Launches	Less Than 5
Indication	Herceptin is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.
Complexities	Yes

Executive Summary

Patent Status

Launch Timelines and Competition

Company	FTF Status / 180 days exclusivity	30-Months stay	Current Litigation Status	Current Approval Status	Likelihood of launch
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Chronology Of Events