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Apil Company Profile

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APIL has twenty-five approved drugs.

There are nineteen US patents protecting APIL drugs.

There are three hundred and one patent family members on APIL drugs in fifty-three countries and forty-five supplementary protection certificates in twelve 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	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-002	Aug 20, 2004		DISCN	Yes	No	7,799,771	Start Trial	Y			Start Trial
Apil	FEMCON FE	ethinyl estradiol; norethindrone	TABLET, CHEWABLE;ORAL	021490-001	Nov 14, 2003		DISCN	Yes	No	6,667,050	Start Trial	Y			Start Trial
Apil	ASACOL HD	mesalamine	TABLET, DELAYED RELEASE;ORAL	021830-001	May 29, 2008	AB	RX	Yes	Yes	9,089,492	Start Trial	Y			Start Trial
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-003	May 25, 2002	AB	RX	Yes	Yes	5,994,329*PED	Start Trial				Start Trial
Apil	DELZICOL	mesalamine	CAPSULE, DELAYED RELEASE;ORAL	204412-001	Feb 1, 2013	AB	RX	Yes	Yes	6,649,180	Start Trial	Y			Start Trial
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-003	May 25, 2002	AB	RX	Yes	Yes	6,465,443*PED	Start Trial				Start Trial
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-003	May 25, 2002	AB	RX	Yes	Yes	6,015,801*PED	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	020835-003	May 25, 2002	5,583,122*PED	Start Trial
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-002	Apr 14, 2000	6,165,513*PED	Start Trial
Apil	ATELVIA	risedronate sodium	TABLET, DELAYED RELEASE;ORAL	022560-001	Oct 8, 2010	5,622,721	Start Trial
Apil	DIDRONEL	etidronate disodium	TABLET;ORAL	017831-002	Approved Prior to Jan 1, 1982	4,137,309	Start Trial
Apil	LO LOESTRIN FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	022501-001	Oct 21, 2010	5,552,394	Start Trial
Apil	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ethinyl estradiol; norethindrone	TABLET, CHEWABLE;ORAL	022573-001	Dec 22, 2010	6,667,050	Start Trial
Apil	ASACOL HD	mesalamine	TABLET, DELAYED RELEASE;ORAL	021830-001	May 29, 2008	5,541,171	Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ Subscribe	Chewable Tablets	1 mg/0.02 mg and 75 mg	➤ Subscribe	2014-04-23
➤ 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	Tablets	1 mg/0.02 mg and 75 mg	➤ Subscribe	2006-04-17
➤ 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

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Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	0059482	Start Trial
Poland	196823	Start Trial
Australia	2002359758	Start Trial
Morocco	28657	Start Trial
Taiwan	I347188	Start Trial
Israel	160797	Start Trial
New Zealand	561708	Start Trial
>Country	>Patent Number	>Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0771217	07C0001	France	Start Trial	PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
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
0398460	04C0022	France	Start Trial	PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
1175904	CA 2007 00045	Denmark	Start Trial	PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, OG COLECALCIFEROL
0136011	C00136011/03	Switzerland	Start Trial	PRODUCT NMAE: ESTRADIOL UND MEDROXYPROGESTERONACETAT; REGISTRATION NO/DATE: IKS 55288 20000417
1175904	C300292	Netherlands	Start Trial	PRODUCT NAME: ALENDRONINE ZUUR, BIJ VOORKEUR MET MONONATRIUMZOUT IN HET BIJZONDER HET MONONATRIUM TRIHYDRAATZOUT, EN COLECALCIFEROL, WAARIN 70MG ALENDRONINEZUUR AANWEZIG IS, GEBASSERD OP HET GEWICHT VAN ALENDRONINE; REGISTRATION NO/DATE: EU/1/05/310/001-005 20050824
1175904	91364	Luxembourg	Start Trial	91364, EXPIRES: 20200826
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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