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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.

Summary for Apil

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	LOESTRIN FE 1/20	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	017354-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-003	Aug 20, 2004		DISCN	Yes	No	7,572,779
Apil	ASACOL HD	mesalamine	TABLET, DELAYED RELEASE;ORAL	021830-001	May 29, 2008	AB	RX	Yes	Yes	8,580,302		Y
Apil	ASACOL	mesalamine	TABLET, DELAYED RELEASE;ORAL	019651-001	Jan 31, 1992		DISCN	No	No
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	FEMHRT	ethinyl estradiol; norethindrone acetate	TABLET;ORAL	021065-002	Oct 15, 1999	5,208,225
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-002	Apr 14, 2000	6,015,801
Apil	DIDRONEL	etidronate disodium	TABLET;ORAL	017831-002	Approved Prior to Jan 1, 1982	4,216,211
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-001	Mar 27, 1998	5,994,329
Apil	ATELVIA	risedronate sodium	TABLET, DELAYED RELEASE;ORAL	022560-001	Oct 8, 2010	5,622,721

Paragraph IV (Patent) Challenges for APIL drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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
	Chewable Tablets	0.4 mg/0.035 mg		2007-04-27
	Delayed-release Tablets	400 mg		2007-06-22

International Patents for Apil Drugs

Country	Document Number	Estimated Expiration
Canada	2481142
Hong Kong	1028187
Argentina	098686
United Kingdom	2336311
Uruguay	27802

Supplementary Protection Certificates for Apil Drugs

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
156	Luxembourg		PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
C/GB04/032	United Kingdom		PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
00191	Netherlands		PRODUCT NAME: DARIFENACINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROBROMIDE; REGISTRATION NO/DATE: EU1/04/294/001 - 012, 20041022
C0018	France		PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
2006002	Lithuania		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

Similar Applicant Names

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

• Apil