Apil Company Profile

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What is the competitive landscape for APIL

APIL has fifteen approved drugs.

There are four US patents protecting APIL drugs.

Summary for Apil

US Patents:	4
Tradenames:	16
Ingredients:	8
NDAs:	15

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	NORCO	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	040148-001	Feb 14, 1997		DISCN	No	No
Apil	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	040148-002	Feb 14, 1997		DISCN	No	No
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-002	Apr 14, 2000		DISCN	Yes	No
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-001	Aug 20, 2004		DISCN	Yes	No
Apil	SARAFEM	fluoxetine hydrochloride	TABLET;ORAL	021860-003	May 19, 2006		DISCN	Yes	No
Apil	MINASTRIN 24 FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	203667-001	May 8, 2013		DISCN	Yes	No

Expired US Patents for Apil

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	FEMCON FE	ethinyl estradiol; norethindrone	TABLET;ORAL	021490-001	Nov 14, 2003	6,667,050
Apil	DIDRONEL	etidronate disodium	TABLET;ORAL	017831-002	Approved Prior to Jan 1, 1982	3,524,844
Apil	DIDRONEL	etidronate disodium	TABLET;ORAL	017831-001	Approved Prior to Jan 1, 1982	4,137,309
Apil	LO MINASTRIN FE	ethinyl estradiol; norethindrone acetate	TABLET, CHEWABLE, TABLET;ORAL	204654-001	Jul 24, 2013	6,667,050
Apil	ATELVIA	risedronate sodium	TABLET, DELAYED RELEASE;ORAL	022560-001	Oct 8, 2010	8,246,989
Apil	DIDRONEL	etidronate disodium	TABLET;ORAL	017831-002	Approved Prior to Jan 1, 1982	4,216,211

Paragraph IV (Patent) Challenges for APIL drugs

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

International Patents for Apil Drugs

Country	Patent Number	Estimated Expiration
South Korea	20070111551
South Africa	200609446
China	1956706
Japan	4605221
Russian Federation	2006140888
China	101189015

Supplementary Protection Certificates for Apil Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1214076	SZ 49/2008	Austria		PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
0771217	CA 2006 00038	Denmark		PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
0398460	C300221	Netherlands		PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
0770388	2009/012	Ireland		PRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103
1453521	15C0050	France		PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 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

Similar Applicant Names

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

• Apil