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Apil Company Profile

APIL has twenty-five approved drugs.

There are nineteen US patents protecting APIL drugs.

There are three hundred 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	ATELVIA	risedronate sodium	TABLET, DELAYED RELEASE;ORAL	022560-001	Oct 8, 2010	AB	RX	Yes	Yes	7,645,459	➤ Sign Up	Y			➤ Sign Up
Apil	ASACOL HD	mesalamine	TABLET, DELAYED RELEASE;ORAL	021830-001	May 29, 2008	AB	RX	Yes	Yes	6,893,662	➤ Sign Up	Y			➤ Sign Up
Apil	FEMCON FE	ethinyl estradiol; norethindrone	TABLET, CHEWABLE;ORAL	021490-001	Nov 14, 2003	AB	RX	Yes	Yes	6,667,050	➤ Sign Up	Y			➤ Sign Up
Apil	ATELVIA	risedronate sodium	TABLET, DELAYED RELEASE;ORAL	022560-001	Oct 8, 2010	AB	RX	Yes	Yes	8,246,989	➤ Sign Up	Y			➤ Sign Up
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-001	Mar 27, 1998	AB	RX	Yes	No		➤ Sign Up				➤ Sign Up
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-001	Aug 20, 2004		DISCN	Yes	No	7,799,771	➤ Sign Up	Y			➤ Sign Up
Apil	ENABLEX	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	021513-001	Dec 22, 2004	AB	RX	Yes	No		➤ Sign Up				➤ Sign Up
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	020835-002	Apr 14, 2000	6,015,801	➤ Sign Up
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-003	May 25, 2002	6,432,932*PED	➤ Sign Up
Apil	DIDRONEL	etidronate disodium	TABLET;ORAL	017831-001	Approved Prior to Jan 1, 1982	4,254,114	➤ Sign Up
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-004	Apr 16, 2007	6,165,513*PED	➤ Sign Up
Apil	TAYTULLA	ethinyl estradiol; norethindrone acetate	CAPSULE;ORAL	204426-001	Apr 19, 2013	5,552,394	➤ Sign Up
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-001	Mar 27, 1998	6,096,342*PED	➤ Sign Up
Apil	ENABLEX	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	021513-002	Dec 22, 2004	6,106,864	➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ 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

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Country	Patent Number	Estimated Expiration
Hungary	0201444	➤ Sign Up
Croatia	P20000035	➤ Sign Up
World Intellectual Property Organization (WIPO)	2005115331	➤ Sign Up
Argentina	039978	➤ Sign Up
China	1273141	➤ Sign Up
San Marino	AP200700047	➤ Sign Up
Peru	02562006	➤ Sign Up
Country	Patent Number	Estimated Expiration

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0398460	C300221	Netherlands	➤ Sign Up	PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
0584952	99C0004	Belgium	➤ Sign Up	PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306
0388054	05C0017	France	➤ Sign Up	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
0998292	CA 2006 00005	Denmark	➤ Sign Up	PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, COLECALCIFEROL
1175904	PA2007007	Lithuania	➤ Sign Up	PRODUCT NAME: ACIDUM ALENDRONICUM NATRIUM, COLECALCIFEROLUM; REGISTRATION NO/DATE: EU/1/05/310/001 2005 08 24 EU/1/05/310/002 2005 08 24 EU/1/05/310/003 2005 08 24 EU/1/05/310/004 2005 08 24 EU/1/05/310/00 20050824
0770388	2009/012	Ireland	➤ Sign Up	PRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103
0998292	PA2006002	Lithuania	➤ Sign Up	PRODUCT NAME: NATRIUM ALENDRONICUM/COLECACIFEROLUM; REGISTRATION NO/DATE: EU/1/05/310/001, EU/1/05/310/002, EU/1/05/310/003, EU/1/05/310/004, EU/1/05/310/005 20050824
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description

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