Apil Company Profile

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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-one supplementary protection certificates in fourteen 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	DIDRONEL	etidronate disodium	TABLET;ORAL	017831-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No		⤷ Sign Up				⤷ Sign Up
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-001	Aug 20, 2004		DISCN	Yes	No	7,572,779	⤷ Sign Up				⤷ Sign Up
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-002	Aug 20, 2004		DISCN	Yes	No	7,572,779	⤷ Sign Up				⤷ Sign Up
Apil	DIDRONEL	etidronate disodium	TABLET;ORAL	017831-002	Approved Prior to Jan 1, 1982		DISCN	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	020835-001	Mar 27, 1998	5,994,329	⤷ Sign Up
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-002	Apr 14, 2000	6,165,513*PED	⤷ Sign Up
Apil	ATELVIA	risedronate sodium	TABLET, DELAYED RELEASE;ORAL	022560-001	Oct 8, 2010	5,583,122*PED	⤷ Sign Up
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-001	Mar 27, 1998	6,096,342*PED	⤷ Sign Up
>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	35 mg	➤ Subscribe	2011-07-19
➤ 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	Tablets	5 mg, 30 mg and 35 mg	➤ Subscribe	2004-04-23
➤ Subscribe	Tablets	150 mg	➤ Subscribe	2008-08-12

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1453521	122015000093	Germany	⤷ Sign Up	PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
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
0770388	09C0018	France	⤷ Sign Up	PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
2782584	2021C/558	Belgium	⤷ Sign Up	PRODUCT NAME: COMPOSITION CONTENANT A LA FOIS DE L'ESTRADIOL (17--ESTRADIOL), EVENTUELLEMENT SOUS FORME D'UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI (Y COMPRIS SOUS FORME HEMIHYDRATEE), ET DE LA PROGESTERONE; AUTHORISATION NUMBER AND DATE: BE582231 20210406
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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