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Apil Company Profile

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APIL has nineteen approved drugs.

There are fourteen US patents protecting APIL drugs.

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

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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
Apil	MINASTRIN 24 FE	ethinyl estradiol; norethindrone acetate	TABLET, CHEWABLE;ORAL	203667-001	May 8, 2013	AB	RX	Yes	Yes		Start Trial				Start Trial
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-003	Aug 20, 2004		DISCN	Yes	No	6,962,908	Start Trial	Y			Start Trial
Apil	FEMHRT	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	021065-001	Jan 14, 2005	AB	RX	No	No		Start Trial				Start Trial
Apil	LO LOESTRIN FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	022501-001	Oct 21, 2010		RX	Yes	Yes	7,704,984	Start Trial				Start Trial
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-002	Aug 20, 2004		DISCN	Yes	No	7,799,771	Start Trial	Y			Start Trial
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-002	Aug 20, 2004		DISCN	Yes	No	7,572,779	Start Trial				Start Trial
Apil	FEMCON FE	ethinyl estradiol; norethindrone	TABLET, CHEWABLE;ORAL	021490-001	Nov 14, 2003		DISCN	Yes	No		Start Trial				Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-005	Apr 22, 2008	6,165,513*PED	Start Trial
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-003	May 25, 2002	6,015,801*PED	Start Trial
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-001	Mar 27, 1998	5,994,329	Start Trial
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-003	May 25, 2002	6,165,513*PED	Start Trial
Apil	FEMCON FE	ethinyl estradiol; norethindrone	TABLET, CHEWABLE;ORAL	021490-001	Nov 14, 2003	6,667,050	Start Trial
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-002	Apr 14, 2000	6,165,513*PED	Start Trial
Apil	DIDRONEL	etidronate disodium	TABLET;ORAL	017831-001	Approved Prior to Jan 1, 1982	3,683,080	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Delayed-release Tablets	800 mg	➤ Subscribe	2011-07-13
➤ Subscribe	Extended-release Tablets	7.5 mg and 15 mg	➤ Subscribe	2008-12-22
➤ Subscribe	Tablets	75 mg	➤ Subscribe	2007-09-10
➤ Subscribe	Chewable Tablets	0.4 mg/0.035 mg	➤ Subscribe	2007-04-27
➤ Subscribe	Delayed-release Tablets	400 mg	➤ Subscribe	2007-06-22
➤ Subscribe	Delayed-release Tablets	35 mg	➤ Subscribe	2011-07-19
➤ Subscribe	Tablets	5 mg, 30 mg and 35 mg	➤ Subscribe	2004-04-23
➤ Subscribe	Tablets	150 mg	➤ Subscribe	2008-08-12
➤ Subscribe	Delayed-release Capsules	400 mg	➤ Subscribe	2014-06-17
➤ Subscribe	Chewable Tablets	1 mg/0.02 mg and 75 mg	➤ Subscribe	2014-04-23

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Country	Patent Number	Estimated Expiration
Norway	328734	Start Trial
Portugal	1753395	Start Trial
World Intellectual Property Organization (WIPO)	2006115871	Start Trial
South Korea	20090106663	Start Trial
Spain	2191595	Start Trial
Hong Kong	1080409	Start Trial
China	102225047	Start Trial
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0388054	05C0017	France	Start Trial	PRODUCT NAME: DARIFENACINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI CI; REGISTRATION NO/DATE IN FRANCE: EU/1/04/294/001 DU 20041022; REGISTRATION NO/DATE AT EEC: EU/01/04/294/001-012 DU 20041022
1380301	2009C/007	Belgium	Start Trial	PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
0402407	97C0005	Belgium	Start Trial	PRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711
1453521	132016000025143	Italy	Start Trial	PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
1214076	SZ 49/2008	Austria	Start Trial	PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
1453521	93156	Luxembourg	Start Trial	PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
0850059	22/2005	Austria	Start Trial	PRODUCT NAME: DARIFENACIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ HIEVON; REGISTRATION NO/DATE: EU/1/04/294/001- EU/1/04/294/012 20041022
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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