ACTIVELLA Drug Patent Profile

Which patents cover Activella, and when can generic versions of Activella launch?

Activella is a drug marketed by Amneal and is included in one NDA.

The generic ingredient in ACTIVELLA is estradiol; norethindrone acetate. There are seventy-five drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the estradiol; norethindrone acetate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Activella

A generic version of ACTIVELLA was approved as estradiol; norethindrone acetate by BRECKENRIDGE PHARM on April 17^th, 2008.

Summary for ACTIVELLA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	6
Patent Applications:	5,659
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ACTIVELLA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ACTIVELLA
What excipients (inactive ingredients) are in ACTIVELLA?	ACTIVELLA excipients list
DailyMed Link:	ACTIVELLA at DailyMed

See drug prices for ACTIVELLA

See drug sales revenues for ACTIVELLA

Recent Clinical Trials for ACTIVELLA

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

Sponsor	Phase
AbbVie	Phase 3
Gretchen Wells	Phase 4
AbbVie	Phase 2

See all ACTIVELLA clinical trials

Pharmacology for ACTIVELLA

Drug Class	Estrogen Progestin
Mechanism of Action	Estrogen Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for ACTIVELLA

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 ACTIVELLA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal	ACTIVELLA	estradiol; norethindrone acetate	TABLET;ORAL	020907-002	Dec 28, 2006		DISCN	Yes	No
Amneal	ACTIVELLA	estradiol; norethindrone acetate	TABLET;ORAL	020907-001	Nov 18, 1998	AB	RX	Yes	Yes

Expired US Patents for ACTIVELLA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Amneal	ACTIVELLA	estradiol; norethindrone acetate	TABLET;ORAL	020907-001	Nov 18, 1998

International Patents for ACTIVELLA

See the table below for patents covering ACTIVELLA around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	10199001
Luxembourg	91096
New Zealand	209066	PHARMACEUTICAL COMPOSITIONS CONTAINING PROGESTOGEN AND ESTROGEN
Netherlands	300022
European Patent Office	0136011	Méthode de traitement hormonal de troubles de la périménopause, ménopause et postménopause et emballage à préparations multiples dans ce but (A method of hormonal treatment of peri-menopausal, menopausal and post-menopausal disorders and multi-preparation pack therefor)

Supplementary Protection Certificates for ACTIVELLA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0136011	91096	Luxembourg		91096, EXPIRES: 20090802
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1380301	2009C/007	Belgium		PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
0136011	SPC/GB00/028	United Kingdom		SPC/GB00/028: 20040802, EXPIRES: 20090801
0136011	97C0056	Belgium		PRODUCT NAME: OESTROGENES CONJUGUES + MEDROXYPROGESTERONACETAS; NAT. REGISTRATION NO/DATE: 428 IS 194 F 3 19970520; FIRST REGISTRATION: CH 52649 19940826