Rinvoq - (15 mg; Tablet Extented Release)

Generic Name	Upadacitinib	Innovator	Abbvie
Dosage	15 mg; Tablet Extented Release	Branded US Sales	More Than $1000 mn
Probable FTF	Less Than 5	Known Para IV Filers	Less Than 5
Other ANDA developers	More Than 5	Tentative Approvals	None
Final Approvals	None	Generic Launches	None
Indication	RINVOQ is a Janus kinase (JAK) inhibitor indicated for the treatment of: *Adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers. *Adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers. *Adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable. *Adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers. *Adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers.
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
******	*** \ *********	*** **, ****	*******	****	*** ****** *** ****
*********	*** \ *********	*** **, ****	*******	****	*** ****** *** ****
******	*** \ *********	*** **, ****	*******	****	*** ****** *** ****

Chronology Of Events

Rinvoq - (45 mg; Tablet Extented Release)

Generic Name	Upadacitinib	Innovator	Abbvie
Dosage	45 mg; Tablet Extented Release	Branded US Sales	More Than $1000 mn
Probable FTF	Less Than 5	Known Para IV Filers	Less Than 5
Other ANDA developers	More Than 5	Tentative Approvals	None
Final Approvals	None	Generic Launches	None
Indication	RINVOQ is a Janus kinase (JAK) inhibitor indicated for the treatment of: *Adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers. *Adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers. *Adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable. *Adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers. *Adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers.
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
******	*** \ *********	*** **, ****	*******	****	*** ****** *** ****
******	*** \ *********	*** **, ****	**** ***	****	*** ****** *** ****
****** (*****)	*** \ *********	*** **, ****	*******	****	*** ****** *** ****

Chronology Of Events

Rinvoq - (30 mg; Tablet Extented Release)

Generic Name	Upadacitinib	Innovator	Abbvie
Dosage	30 mg; Tablet Extented Release	Branded US Sales	More Than $1000 mn
Probable FTF	Less Than 5	Known Para IV Filers	Less Than 5
Other ANDA developers	More Than 5	Tentative Approvals	None
Final Approvals	None	Generic Launches	None
Indication	RINVOQ is a Janus kinase (JAK) inhibitor indicated for the treatment of: *Adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers. *Adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers. *Adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable. *Adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers. *Adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers.
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
******	*** \ *********	*** **, ****	*******	****	*** ****** *** ****
*********	*** \ *********	*** **, ****	*******	****	*** ****** *** ****
******	*** \ *********	*** **, ****	**** ***	****	*** ****** *** ****

Chronology Of Events