Research Delta | Prolia And Xgeva

Prolia and Xgeva - (60mg/mL, 70mg/mL; Injection, Subcutaneous)

Generic Name	Denosumab	Innovator	Amgen
Dosage	60mg/mL, 70mg/mL; Injection, Subcutaneous	Branded US Sales	More Than $1000 mn
Probable FTF	None	Known Para IV Filers	Less Than 5
Other ANDA developers	None	Tentative Approvals	None
Final Approvals	Less Than 5	Generic Launches	None
Indication	Prolia is a RANK ligand (RANKL) inhibitor indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture. Xgeva is a RANK ligand (RANKL) inhibitor indicated for Prevention of skeletal-related events in patients with bone metastases from solid tumors
Complexities	Yes

Executive Summary

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Patent Status

Prolia and Xgeva	Patent 1	Patent 2	Patent 3	Patent 4	Patent 5	Patent 6	Patent 7	Patent 8	Patent 9	Patent 10	Patent 11	Patent 12	Patent 13	Patent 14	Patent 15	Patent 16	Patent 17	Patent 18	Patent 19	Patent 20	Patent 21	Patent 22	Patent 23	Patent 24	Patent 25	Patent 26	Patent 27	Patent 28	Patent 29	Patent 30	Patent 31	Patent 32	Patent 33	Patent 34	Patent 35	Patent 36	Patent 37	Patent 38	Patent 39	Patent 40	Patent 41	Patent 42	Patent 43	Patent 44	Patent 45	Patent 46
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Launch Timelines and Competition

Company	Current Litigation Status	Current Approval Status	Likelihood of launch
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Chronology Of Events

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Prolia and Xgeva - (60mg/mL, 70mg/mL; Injection, Subcutaneous)

Executive Summary

Patent Status

Launch Timelines and Competition

Chronology Of Events

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