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Baxter
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Citi
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Colorcon
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Generated: May 22, 2019

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Apil Company Profile

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Summary for Apil
International Patents:300
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 ATELVIA risedronate sodium TABLET, DELAYED RELEASE;ORAL 022560-001 Oct 8, 2010 AB RX Yes Yes 7,645,459 ➤ Sign Up Y ➤ Sign Up
Apil ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830-001 May 29, 2008 AB RX Yes Yes 6,893,662 ➤ Sign Up Y ➤ Sign Up
Apil FEMCON FE ethinyl estradiol; norethindrone TABLET, CHEWABLE;ORAL 021490-001 Nov 14, 2003 AB RX Yes Yes 6,667,050 ➤ Sign Up Y ➤ Sign Up
Apil ATELVIA risedronate sodium TABLET, DELAYED RELEASE;ORAL 022560-001 Oct 8, 2010 AB RX Yes Yes 8,246,989 ➤ Sign Up Y ➤ Sign Up
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-001 Mar 27, 1998 AB RX Yes No ➤ Sign Up ➤ Sign Up
Apil FEMTRACE estradiol acetate TABLET;ORAL 021633-001 Aug 20, 2004 DISCN Yes No 7,799,771 ➤ Sign Up Y ➤ Sign Up
Apil ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513-001 Dec 22, 2004 AB RX Yes No ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for Apil

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-002 Apr 14, 2000 6,015,801 ➤ Sign Up
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002 6,432,932*PED ➤ Sign Up
Apil DIDRONEL etidronate disodium TABLET;ORAL 017831-001 Approved Prior to Jan 1, 1982 4,254,114 ➤ Sign Up
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-004 Apr 16, 2007 6,165,513*PED ➤ Sign Up
Apil TAYTULLA ethinyl estradiol; norethindrone acetate CAPSULE;ORAL 204426-001 Apr 19, 2013 5,552,394 ➤ Sign Up
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-001 Mar 27, 1998 6,096,342*PED ➤ Sign Up
Apil ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513-002 Dec 22, 2004 6,106,864 ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for APIL drugs
Drugname Dosage Strength Tradename Submissiondate
➤ 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
➤ 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

Supplementary Protection Certificates for Apil Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0398460 C300221 Netherlands ➤ Sign Up PRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
0584952 99C0004 Belgium ➤ Sign Up PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306
0388054 05C0017 France ➤ Sign Up 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
0998292 CA 2006 00005 Denmark ➤ Sign Up PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, COLECALCIFEROL
1175904 PA2007007 Lithuania ➤ Sign Up PRODUCT NAME: ACIDUM ALENDRONICUM NATRIUM, COLECALCIFEROLUM; REGISTRATION NO/DATE: EU/1/05/310/001 2005 08 24 EU/1/05/310/002 2005 08 24 EU/1/05/310/003 2005 08 24 EU/1/05/310/004 2005 08 24 EU/1/05/310/00 20050824
0770388 2009/012 Ireland ➤ Sign Up PRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103
0998292 PA2006002 Lithuania ➤ Sign Up 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
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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

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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Julphar
Moodys
Accenture
AstraZeneca
McKinsey

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