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Apil Company Profile

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What is the competitive landscape for APIL, and when can generic versions of APIL drugs launch?

APIL has twenty-five approved drugs.

There are twenty US patents protecting APIL drugs.

There are three hundred and thirty-two patent family members on APIL drugs in fifty-three countries and forty-one supplementary protection certificates in eleven countries.

Summary for Apil

International Patents:	332
US Patents:	20
Tradenames:	26
Ingredients:	10
NDAs:	25

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	SARAFEM	fluoxetine hydrochloride	TABLET;ORAL	021860-003	May 19, 2006	AB1	RX	Yes	Yes
Apil	ESTROSTEP FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	020130-002	Oct 9, 1996	AB	RX	Yes	Yes
Apil	NORCO	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	040148-001	Feb 14, 1997	AA	RX	No	Yes
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-003	Aug 20, 2004		DISCN	Yes	No	6,962,908		Y
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-001	Aug 20, 2004		DISCN	Yes	No	7,799,771		Y
Apil	SARAFEM	fluoxetine hydrochloride	TABLET;ORAL	021860-002	May 19, 2006	AB1	RX	Yes	No

Expired US Patents for Apil

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	ENABLEX	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	021513-002	Dec 22, 2004	5,096,890
Apil	ASACOL HD	mesalamine	TABLET, DELAYED RELEASE;ORAL	021830-001	May 29, 2008	5,541,170
Apil	ATELVIA	risedronate sodium	TABLET, DELAYED RELEASE;ORAL	022560-001	Oct 8, 2010	5,622,721
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-001	Mar 27, 1998	6,015,801
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-003	May 25, 2002	6,096,342*PED
Apil	ENABLEX	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	021513-001	Dec 22, 2004	5,096,890

Paragraph IV (Patent) Challenges for APIL drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	Chewable Tablets	0.4 mg/0.035 mg		2007-04-27
	Delayed-release Tablets	400 mg		2007-06-22
	Delayed-release Tablets	35 mg		2011-07-19
	Tablets	5 mg, 30 mg and 35 mg		2004-04-23
	Tablets	150 mg		2008-08-12
	Delayed-release Capsules	400 mg		2014-06-17
	Chewable Tablets	1 mg/0.02 mg and 75 mg		2014-04-23
	Delayed-release Tablets	800 mg		2011-07-13
	Extended-release Tablets	7.5 mg and 15 mg		2008-12-22
	Tablets	75 mg		2007-09-10
	Tablets	1 mg/0.02 mg and 75 mg		2006-04-17

International Patents for Apil Drugs

Country	Document Number	Estimated Expiration
Israel	179090
World Intellectual Property Organization (WIPO)	9904773
Japan	2013166773
Poland	337813
Spain	2269014
New Zealand	508507

Supplementary Protection Certificates for Apil Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0814	Netherlands		PRODUCT NAME: LEVONORGESTREL EN ETHINYLESTRADIOL; NATIONAL REGISTRATION NO/DATE: RVG 117453 20151211; FIRST REGISTRATION: SK 17/0017/15-S 20150211
C0005	Belgium		PRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711
09/012	Ireland		PRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103
2007 00045	Denmark		PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, OG COLECALCIFEROL
C0001	France		PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
1214076/01	Switzerland		PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008

Similar Applicant Names

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

• Apil