Apil Company Profile

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

APIL has nineteen approved drugs.

There are seven US patents protecting APIL drugs.

There are one hundred and sixty-one patent family members on APIL drugs in thirty-seven countries and forty-three supplementary protection certificates in fourteen countries.

Summary for Apil

International Patents:	161
US Patents:	7
Tradenames:	20
Ingredients:	9
NDAs:	19

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	DIDRONEL	etidronate disodium	TABLET;ORAL	017831-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Apil	ESTROSTEP 21	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-21	020130-001	Oct 9, 1996		DISCN	Yes	No
Apil	DIDRONEL	etidronate disodium	TABLET;ORAL	017831-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Apil	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ethinyl estradiol; norethindrone	TABLET, CHEWABLE;ORAL	022573-001	Dec 22, 2010	AB	RX	Yes	Yes
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-005	Apr 22, 2008	AB	RX	Yes	Yes	7,718,634*PED				Y
Apil	NORCO	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	040148-003	Sep 12, 2000		DISCN	No	No
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-002	Aug 20, 2004		DISCN	Yes	No	7,572,779

Expired US Patents for Apil

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
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	6,432,932*PED
Apil	NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE	ethinyl estradiol; norethindrone	TABLET, CHEWABLE;ORAL	022573-001	Dec 22, 2010	5,552,394
Apil	ENABLEX	darifenacin hydrobromide	TABLET, EXTENDED RELEASE;ORAL	021513-001	Dec 22, 2004	6,106,864
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-001	Mar 27, 1998	6,165,513*PED
Apil	FEMCON FE	ethinyl estradiol; norethindrone	TABLET;ORAL	021490-001	Nov 14, 2003	6,667,050
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-002	Apr 14, 2000	5,994,329

Paragraph IV (Patent) Challenges for APIL drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
	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
	Chewable Tablets	1 mg/0.02 mg and 75 mg		2014-04-23
	Delayed-release Capsules	400 mg		2014-06-17
	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
	Chewable Tablets	0.4 mg/0.035 mg		2007-04-27

International Patents for Apil Drugs

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	03055495
World Intellectual Property Organization (WIPO)	2006115871
Cyprus	1116233
Israel	164371
Norway	20100477
Brazil	PI0511530
Taiwan	I347188

Supplementary Protection Certificates for Apil Drugs

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0770388	PA2009004,C0770388	Lithuania		PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
1453521	132016000025143	Italy		PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
0770388	PA2009004	Lithuania		PRODUCT NAME: ESTRADIOLI VALERAS + DIENOGESTUM; NAT. REGISTRATION NO/DATE: LT/1/09/1512/001, 2009 04 06 LT/1/09/1512/002, 2009 04 06 LT/1/09/1512/003 20090406; FIRST REGISTRATION: BE 327792 20081103
2782584	132021000000197	Italy		PRODUCT NAME: ESTRADIOLO (17SS-ESTRADIOLO) IN PARTICOLARE NELLA FORMA EMIIDRATA, E PROGESTERONE COMPRENDENTI LE VARIE FORME DI ESTRADIOLO (17SS-ESTRADIOLO), QUALI LE FORME IDRATE E SOLVATATE, INCLUDENDO LA FORMA EMIIDRATA, ED I SUOI SALI.(BIJUVA); AUTHORISATION NUMBER(S) AND DATE(S): BE582231, 20210406;048335018 -048335020, 20210517
2782584	301153	Netherlands		PRODUCT NAME: COMPOSITION CONTAINING BOTH ESTRADIOL (17SS-ESTRADIOL), OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF (INCLUDING IN HEMIHYDRATE FORM), AND PROGESTERONE; NATIONAL REGISTRATION NO/DATE: RVG 125821 20210611; FIRST REGISTRATION: BE BE582231 20210406
0850059	22/2005	Austria		PRODUCT NAME: DARIFENACIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ HIEVON; REGISTRATION NO/DATE: EU/1/04/294/001- EU/1/04/294/012 20041022
1453521	122015000093	Germany		PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129

Similar Applicant Names

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

• Apil