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Last Updated: January 25, 2020

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Apil Company Profile

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Summary for Apil
International Patents:301
US Patents:19
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 FEMTRACE estradiol acetate TABLET;ORAL 021633-002 Aug 20, 2004 DISCN Yes No 7,799,771   Start Trial Y   Start Trial
Apil FEMCON FE ethinyl estradiol; norethindrone TABLET, CHEWABLE;ORAL 021490-001 Nov 14, 2003 DISCN Yes No 6,667,050   Start Trial Y   Start Trial
Apil ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830-001 May 29, 2008 AB RX Yes Yes 9,089,492   Start Trial Y   Start Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002 AB RX Yes Yes 5,994,329*PED   Start Trial   Start Trial
Apil DELZICOL mesalamine CAPSULE, DELAYED RELEASE;ORAL 204412-001 Feb 1, 2013 AB RX Yes Yes 6,649,180   Start Trial Y   Start Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002 AB RX Yes Yes 6,465,443*PED   Start Trial   Start Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002 AB RX Yes Yes 6,015,801*PED   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 DIDRONEL etidronate disodium TABLET;ORAL 017831-002 Approved Prior to Jan 1, 1982 4,137,309   Start Trial
Apil LO LOESTRIN FE ethinyl estradiol; norethindrone acetate TABLET;ORAL 022501-001 Oct 21, 2010 5,552,394   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
>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 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 Tablets 1 mg/0.02 mg and 75 mg ➤ Subscribe 2006-04-17
➤ 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
➤ Subscribe Tablets 150 mg ➤ Subscribe 2008-08-12
➤ Subscribe Delayed-release Capsules 400 mg ➤ Subscribe 2014-06-17

Supplementary Protection Certificates for Apil Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0771217 07C0001 France   Start Trial PRODUCT NAME: ETHINYLESTRADIOL BETADEX CLATHRATE; NAT. REGISTRATION NO/DATE: NL 32343 20060710; FIRST REGISTRATION: NL - RVG 31781 20050804
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
0398460 04C0022 France   Start Trial PRODUCT NAME: ESTRADIOL ANHYDRE DROSPIRENONE; REGISTRATION NO/DATE IN FRANCE: NL 28661 DU 20040316; REGISTRATION NO/DATE AT EEC: RVG 27505 DU 20021211
1175904 CA 2007 00045 Denmark   Start Trial PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, OG COLECALCIFEROL
0136011 C00136011/03 Switzerland   Start Trial PRODUCT NMAE: ESTRADIOL UND MEDROXYPROGESTERONACETAT; REGISTRATION NO/DATE: IKS 55288 20000417
1175904 C300292 Netherlands   Start Trial PRODUCT NAME: ALENDRONINE ZUUR, BIJ VOORKEUR MET MONONATRIUMZOUT IN HET BIJZONDER HET MONONATRIUM TRIHYDRAATZOUT, EN COLECALCIFEROL, WAARIN 70MG ALENDRONINEZUUR AANWEZIG IS, GEBASSERD OP HET GEWICHT VAN ALENDRONINE; REGISTRATION NO/DATE: EU/1/05/310/001-005 20050824
1175904 91364 Luxembourg   Start Trial 91364, EXPIRES: 20200826
>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:

McKinsey
Baxter
AstraZeneca
Mallinckrodt
Colorcon
Johnson and Johnson

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