Apil Company Profile

What is the competitive landscape for APIL, and when can generic versions of APIL drugs launch?

APIL has fifteen approved drugs.

There are five US patents protecting APIL drugs.

There are ninety-six patent family members on APIL drugs in thirty-three countries and forty supplementary protection certificates in fourteen countries.

Summary for Apil

International Patents:	96
US Patents:	5
Tradenames:	16
Ingredients:	8
NDAs:	15

Drugs and US Patents for Apil

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Apil	FEMCON FE	ethinyl estradiol; norethindrone	TABLET;ORAL	021490-001	Nov 14, 2003		DISCN	Yes	No
Apil	ESTROSTEP 21	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-21	020130-001	Oct 9, 1996		DISCN	Yes	No
Apil	NORCO	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	040148-003	Sep 12, 2000		DISCN	No	No
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-004	Apr 16, 2007		DISCN	Yes	No
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-001	Mar 27, 1998		DISCN	Yes	No
Apil	ESTROSTEP FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	020130-002	Oct 9, 1996		DISCN	Yes	No

Expired US Patents for Apil

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	ESTROSTEP FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	020130-002	Oct 9, 1996	5,010,070
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-001	Mar 27, 1998	5,994,329
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-004	Apr 16, 2007	6,165,513*PED
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-002	Apr 14, 2000	5,994,329
Apil	ESTROSTEP FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	020130-002	Oct 9, 1996	4,962,098
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-003	May 25, 2002	6,096,342*PED

Paragraph IV (Patent) Challenges for APIL drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Delayed-release Tablets	400 mg		2007-06-22
	Tablets	5 mg, 30 mg and 35 mg		2004-04-23
	Tablets	150 mg		2008-08-12
	Chewable Tablets	1 mg/0.02 mg and 75 mg		2014-04-23
	Delayed-release Tablets	35 mg		2011-07-19
	Tablets	75 mg		2007-09-10
	Chewable Tablets	0.4 mg/0.035 mg		2007-04-27

International Patents for Apil Drugs

Country	Patent Number	Estimated Expiration
Argentina	049022
Spain	2349584
Israel	179090
Canada	2602188
New Zealand	551118
India	827DEN2012

Supplementary Protection Certificates for Apil Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0770388	PA2009004,C0770388	Lithuania		PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
1453521	C201630040	Spain		PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211
1453521	39/2015	Austria		PRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
1214076	C01214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
0334429	97C0002	Belgium		PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
1453521	132016000025143	Italy		PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414

Similar Applicant Names

Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

• Apil