Apil Company Profile

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

APIL has sixteen 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:	17
Ingredients:	8
NDAs:	16

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	ACTONEL	risedronate sodium	TABLET;ORAL	020835-005	Apr 22, 2008	AB	RX	Yes	Yes
Apil	ESTROSTEP FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	020130-002	Oct 9, 1996		DISCN	Yes	No
Apil	LO LOESTRIN FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	022501-001	Oct 21, 2010		RX	Yes	Yes	7,704,984
Apil	ATELVIA	risedronate sodium	TABLET, DELAYED RELEASE;ORAL	022560-001	Oct 8, 2010	AB	RX	Yes	Yes	8,246,989		Y
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-002	Aug 20, 2004		DISCN	Yes	No	7,572,779
Apil	NORCO	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	040148-004	Jul 7, 2014		DISCN	No	No

Expired US Patents for Apil

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	DIDRONEL	etidronate disodium	TABLET;ORAL	017831-002	Approved Prior to Jan 1, 1982	4,216,211
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-002	Aug 20, 2004	7,799,771
Apil	DIDRONEL	etidronate disodium	TABLET;ORAL	017831-001	Approved Prior to Jan 1, 1982	3,683,080
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-003	Aug 20, 2004	6,962,908
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-001	Mar 27, 1998	6,165,513*PED
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-001	Mar 27, 1998	6,096,342*PED

Paragraph IV (Patent) Challenges for APIL drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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
	Delayed-release Tablets	400 mg		2007-06-22

International Patents for Apil Drugs

Country	Patent Number	Estimated Expiration
New Zealand	532491
China	1956706
European Patent Office	2305266
Japan	4788765
Japan	2011529902
Israel	160797

Supplementary Protection Certificates for Apil Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
1453521	C 2015 029	Romania		PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129
0398460	12/2004	Austria		PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
0398460	C300221	Netherlands		PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
0402407	97C0005	Belgium		PRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711
1453521	93156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211

Similar Applicant Names

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

• Apil