LEUPROLIDE ACETATE; NORETHINDRONE ACETATE - Generic Drug Details

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What are the generic sources for leuprolide acetate; norethindrone acetate and what is the scope of freedom to operate?

Leuprolide acetate; norethindrone acetate is the generic ingredient in one branded drug marketed by Abbvie Endocrine and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for LEUPROLIDE ACETATE; NORETHINDRONE ACETATE

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Clinical Trials:	1
DailyMed Link:	LEUPROLIDE ACETATE; NORETHINDRONE ACETATE at DailyMed

Recent Clinical Trials for LEUPROLIDE ACETATE; NORETHINDRONE ACETATE

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

Sponsor	Phase
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 3

See all LEUPROLIDE ACETATE; NORETHINDRONE ACETATE clinical trials

US Patents and Regulatory Information for LEUPROLIDE ACETATE; NORETHINDRONE ACETATE

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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
Abbvie Endocrine	LUPANETA PACK	leuprolide acetate; norethindrone acetate	INJECTABLE, TABLET;INTRAMUSCULAR, ORAL	203696-002	Dec 14, 2012		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie Endocrine	LUPANETA PACK	leuprolide acetate; norethindrone acetate	INJECTABLE, TABLET;INTRAMUSCULAR, ORAL	203696-001	Dec 14, 2012		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 LEUPROLIDE ACETATE; NORETHINDRONE ACETATE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie Endocrine	LUPANETA PACK	leuprolide acetate; norethindrone acetate	INJECTABLE, TABLET;INTRAMUSCULAR, ORAL	203696-001	Dec 14, 2012	⤷ Sign Up	⤷ Sign Up
Abbvie Endocrine	LUPANETA PACK	leuprolide acetate; norethindrone acetate	INJECTABLE, TABLET;INTRAMUSCULAR, ORAL	203696-002	Dec 14, 2012	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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