Last Updated: September 24, 2026

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

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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	ACTONEL	risedronate sodium	TABLET;ORAL	020835-004	Apr 16, 2007		DISCN	Yes	No		⤷ Start Trial				⤷ Start Trial
Apil	ESTROSTEP 21	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-21	020130-001	Oct 9, 1996		DISCN	Yes	No		⤷ Start Trial				⤷ Start Trial
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-001	Mar 27, 1998		DISCN	Yes	No		⤷ Start Trial				⤷ Start Trial
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-002	Aug 20, 2004		DISCN	Yes	No		⤷ Start Trial				⤷ Start Trial
Apil	FEMCON FE	ethinyl estradiol; norethindrone	TABLET;ORAL	021490-001	Nov 14, 2003		DISCN	Yes	No		⤷ Start Trial				⤷ Start Trial
Apil	LO MINASTRIN FE	ethinyl estradiol; norethindrone acetate	TABLET, CHEWABLE, TABLET;ORAL	204654-001	Jul 24, 2013		DISCN	Yes	No	7,704,984	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for Apil

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	ESTROSTEP 21	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-21	020130-001	Oct 9, 1996	5,010,070	⤷ Start Trial
Apil	ESTROSTEP FE	ethinyl estradiol; norethindrone acetate	TABLET;ORAL-28	020130-002	Oct 9, 1996	4,962,098	⤷ Start Trial
Apil	FEMTRACE	estradiol acetate	TABLET;ORAL	021633-002	Aug 20, 2004	6,962,908	⤷ Start Trial
Apil	DIDRONEL	etidronate disodium	TABLET;ORAL	017831-002	Approved Prior to Jan 1, 1982	3,524,844	⤷ Start Trial
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-002	Apr 14, 2000	6,015,801	⤷ Start Trial
Apil	TAYTULLA	ethinyl estradiol; norethindrone acetate	CAPSULE;ORAL	204426-001	Apr 19, 2013	5,552,394	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

Paragraph IV (Patent) Challenges for APIL drugs

Drugname	Dosage	Strength	Tradename	Submissiondate
➤ 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
➤ Subscribe	Chewable Tablets	1 mg/0.02 mg and 75 mg	➤ Subscribe	2014-04-23

International Patents for Apil Drugs

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Country	Patent Number	Estimated Expiration
Poland	2283825	⤷ Start Trial
Hong Kong	1161130	⤷ Start Trial
World Intellectual Property Organization (WIPO)	2010014766	⤷ Start Trial
Brazil	PI0511530	⤷ Start Trial
Morocco	28657	⤷ Start Trial
South Korea	20070111551	⤷ Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for Apil Drugs

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2782584	122021000080	Germany	⤷ Start Trial	PRODUCT NAME: ZUSAMMENSETZUNG, DIE SOWOHL ESTRADIOL (17SS-ESTRADIOL), GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, HYDRATS ODER SOLVATS DAVON (EINSCHLIESSLICH IN FORM EINES HEMIHYDRATS), ALS AUCH PROGESTERON ENTHAELT; AUTHORISATION NO/DATE: 2205034.00.00 20210924; BE582231 20210406
1214076	C01214076/01	Switzerland	⤷ Start Trial	PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
1453521	C201630040	Spain	⤷ Start Trial	PRODUCT NAME: ETINILESTRADIOL Y MEZCLA DE LEVONORGESTREL Y ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: 80340; DATE OF AUTHORISATION: 20160122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150211
1453521	C 2015 029	Romania	⤷ Start Trial	PRODUCT NAME: LEVONORGESTREL SI ETINILESTRADIOL; NATIONAL AUTHORISATION NUMBER: RO 7793/2015/001; DATE OF NATIONAL AUTHORISATION: 20150612; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): SK. 17/0017/15-S; DATE OF FIRST AUTHORISATION IN EEA: 20150129
2782584	301153	Netherlands	⤷ Start Trial	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
0334429	97C0002	Belgium	⤷ Start Trial	PRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Similar Applicant Names

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

Apil

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