Estradiol; norethindrone acetate - Generic Drug Details

What are the generic drug sources for estradiol; norethindrone acetate and what is the scope of patent protection?

Estradiol; norethindrone acetate is the generic ingredient in six branded drugs marketed by Noven Pharms Inc, Amneal, Lupin Ltd, Barr, Breckenridge Pharm, Naari Pte Ltd, Novast Labs, Teva Pharms Usa, Xiromed, Aurobindo Pharma Ltd, and Sumitomo Pharma, and is included in eleven NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Nine suppliers are listed for this compound.

Summary for estradiol; norethindrone acetate

US Patents:	7
Tradenames:	6
Applicants:	11
NDAs:	11
Finished Product Suppliers / Packagers:	9
Clinical Trials:	36
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for estradiol; norethindrone acetate
DailyMed Link:	estradiol; norethindrone acetate at DailyMed

Recent Clinical Trials for estradiol; norethindrone acetate

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

Sponsor	Phase
Bio Genuine (Shanghai) Biotech Co., Ltd.	Phase 3
University of Chicago	Phase 4
Myovant Sciences GmbH	Phase 4

See all estradiol; norethindrone acetate clinical trials

Pharmacology for estradiol; norethindrone acetate

Drug Class	Estrogen Progestin
Mechanism of Action	Estrogen Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for estradiol; norethindrone acetate

G03CA	Natural and semisynthetic estrogens, plain
G03C	ESTROGENS
G03	SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for estradiol; norethindrone acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Naari Pte Ltd	ESTRADIOL AND NORETHINDRONE ACETATE	estradiol; norethindrone acetate	TABLET;ORAL	210233-001	Feb 28, 2018	AB	RX	No	No
Breckenridge Pharm	ESTRADIOL AND NORETHINDRONE ACETATE	estradiol; norethindrone acetate	TABLET;ORAL	078324-001	Apr 17, 2008	AB	RX	No	No
Lupin Ltd	AMABELZ	estradiol; norethindrone acetate	TABLET;ORAL	203339-002	Jun 20, 2016	BX	RX	No	No
Breckenridge Pharm	ESTRADIOL AND NORETHINDRONE ACETATE	estradiol; norethindrone acetate	TABLET;ORAL	078324-002	Jun 9, 2011	AB	RX	No	No
Noven Pharms Inc	COMBIPATCH	estradiol; norethindrone acetate	FILM, EXTENDED RELEASE;TRANSDERMAL	020870-002	Aug 7, 1998		RX	Yes	Yes
Sumitomo Pharma	MYFEMBREE	estradiol; norethindrone acetate; relugolix	TABLET;ORAL	214846-001	May 26, 2021		RX	Yes	Yes
Sumitomo Pharma	MYFEMBREE	estradiol; norethindrone acetate; relugolix	TABLET;ORAL	214846-001	May 26, 2021		RX	Yes	Yes			Y	Y

Expired US Patents for estradiol; norethindrone acetate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Noven Pharms Inc	COMBIPATCH	estradiol; norethindrone acetate	FILM, EXTENDED RELEASE;TRANSDERMAL	020870-001	Aug 7, 1998
Noven Pharms Inc	COMBIPATCH	estradiol; norethindrone acetate	FILM, EXTENDED RELEASE;TRANSDERMAL	020870-001	Aug 7, 1998
Noven Pharms Inc	COMBIPATCH	estradiol; norethindrone acetate	FILM, EXTENDED RELEASE;TRANSDERMAL	020870-002	Aug 7, 1998
Noven Pharms Inc	COMBIPATCH	estradiol; norethindrone acetate	FILM, EXTENDED RELEASE;TRANSDERMAL	020870-002	Aug 7, 1998
Noven Pharms Inc	COMBIPATCH	estradiol; norethindrone acetate	FILM, EXTENDED RELEASE;TRANSDERMAL	020870-002	Aug 7, 1998
Amneal	ACTIVELLA	estradiol; norethindrone acetate	TABLET;ORAL	020907-001	Nov 18, 1998
Noven Pharms Inc	COMBIPATCH	estradiol; norethindrone acetate	FILM, EXTENDED RELEASE;TRANSDERMAL	020870-002	Aug 7, 1998