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Last Updated: January 28, 2021

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Apil Company Profile

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Summary for Apil
International Patents:214
US Patents:14
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 ACTONEL risedronate sodium TABLET;ORAL 020835-004 Apr 16, 2007 DISCN Yes No   Start Trial   Start Trial
Apil MINASTRIN 24 FE ethinyl estradiol; norethindrone acetate TABLET, CHEWABLE;ORAL 203667-001 May 8, 2013 AB RX Yes Yes   Start Trial   Start Trial
Apil FEMTRACE estradiol acetate TABLET;ORAL 021633-002 Aug 20, 2004 DISCN Yes No 6,962,908   Start Trial Y   Start Trial
Apil FEMTRACE estradiol acetate TABLET;ORAL 021633-003 Aug 20, 2004 DISCN Yes No 7,799,771   Start Trial Y   Start Trial
Apil SARAFEM fluoxetine hydrochloride TABLET;ORAL 021860-003 May 19, 2006 AB1 RX Yes Yes   Start Trial   Start Trial
Apil HYDROCODONE BITARTRATE AND ACETAMINOPHEN acetaminophen; hydrocodone bitartrate TABLET;ORAL 040148-002 Feb 14, 1997 DISCN No No   Start Trial   Start Trial
Apil NORCO acetaminophen; hydrocodone bitartrate TABLET;ORAL 040148-005 Jul 7, 2014 AA RX No No   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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002 5,583,122*PED   Start Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-002 Apr 14, 2000 6,165,513*PED   Start Trial
Apil ATELVIA risedronate sodium TABLET, DELAYED RELEASE;ORAL 022560-001 Oct 8, 2010 5,622,721   Start Trial
Apil NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ethinyl estradiol; norethindrone TABLET, CHEWABLE;ORAL 022573-001 Dec 22, 2010 6,667,050   Start Trial
Apil ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830-001 May 29, 2008 5,541,171   Start Trial
Apil DIDRONEL etidronate disodium TABLET;ORAL 017831-002 Approved Prior to Jan 1, 1982 3,683,080   Start Trial
Apil ESTROSTEP FE ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 020130-002 Oct 9, 1996 4,962,098   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 Tablets 150 mg ➤ Subscribe 2008-08-12
➤ Subscribe Delayed-release Capsules 400 mg ➤ Subscribe 2014-06-17
➤ Subscribe Chewable Tablets 1 mg/0.02 mg and 75 mg ➤ Subscribe 2014-04-23
➤ Subscribe Delayed-release Tablets 800 mg ➤ Subscribe 2011-07-13
➤ Subscribe Extended-release Tablets 7.5 mg and 15 mg ➤ Subscribe 2008-12-22
➤ 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 Delayed-release Tablets 35 mg ➤ Subscribe 2011-07-19
➤ Subscribe Tablets 5 mg, 30 mg and 35 mg ➤ Subscribe 2004-04-23

Supplementary Protection Certificates for Apil Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0770388 PA2009004,C0770388 Lithuania   Start Trial 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
0388054 05C0017 France   Start Trial PRODUCT NAME: DARIFENACINE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI CI; REGISTRATION NO/DATE IN FRANCE: EU/1/04/294/001 DU 20041022; REGISTRATION NO/DATE AT EEC: EU/01/04/294/001-012 DU 20041022
1453521 93156 Luxembourg   Start Trial PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
1380301 2009C/007 Belgium   Start Trial PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
1453521 15C0050 France   Start Trial PRODUCT NAME: ETHINYLESTRADIOL ET MELANGE DE LEVONORGESTREL ET ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: NL 42237 20150320; FIRST REGISTRATION: SK - 17/0017/15-S 20150129
0136011 99C0003 Belgium   Start Trial PRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306
0398460 12/2004 Austria   Start Trial PRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
>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.

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Serving leading biopharmaceutical companies globally:

Harvard Business School
McKesson
Mallinckrodt
Express Scripts
AstraZeneca
Baxter

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