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Last Updated: June 6, 2020

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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 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 021633-003 Aug 20, 2004 DISCN Yes No 6,962,908   Start Trial Y   Start Trial
Apil FEMHRT ethinyl estradiol; norethindrone acetate TABLET;ORAL 021065-001 Jan 14, 2005 AB RX No No   Start Trial   Start Trial
Apil LO LOESTRIN FE ethinyl estradiol; norethindrone acetate TABLET;ORAL 022501-001 Oct 21, 2010 RX Yes Yes 7,704,984   Start Trial   Start Trial
Apil FEMTRACE estradiol acetate TABLET;ORAL 021633-002 Aug 20, 2004 DISCN Yes No 7,799,771   Start Trial Y   Start Trial
Apil FEMTRACE estradiol acetate TABLET;ORAL 021633-002 Aug 20, 2004 DISCN Yes No 7,572,779   Start Trial   Start Trial
Apil FEMCON FE ethinyl estradiol; norethindrone TABLET, CHEWABLE;ORAL 021490-001 Nov 14, 2003 DISCN Yes 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 020835-005 Apr 22, 2008 6,165,513*PED   Start Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002 6,015,801*PED   Start Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-001 Mar 27, 1998 5,994,329   Start Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002 6,165,513*PED   Start Trial
Apil FEMCON FE ethinyl estradiol; norethindrone TABLET, CHEWABLE;ORAL 021490-001 Nov 14, 2003 6,667,050   Start Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-002 Apr 14, 2000 6,165,513*PED   Start Trial
Apil DIDRONEL etidronate disodium TABLET;ORAL 017831-001 Approved Prior to Jan 1, 1982 3,683,080   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 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
➤ 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

Supplementary Protection Certificates for Apil Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
1380301 2009C/007 Belgium   Start Trial PRODUCT NAME: DROSPIRENONE-ETHINYLESTRADIOL; AUTHORISATION NUMBER AND DATE: BE321386 20080811
0402407 97C0005 Belgium   Start Trial PRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711
1453521 132016000025143 Italy   Start Trial PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
1214076 SZ 49/2008 Austria   Start Trial PRODUCT NAME: WIRKSTOFFKOMBINATION VON ETHINYLESTRADIOL UND DROSPIRENON
1453521 93156 Luxembourg   Start Trial PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
0850059 22/2005 Austria   Start Trial PRODUCT NAME: DARIFENACIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ HIEVON; REGISTRATION NO/DATE: EU/1/04/294/001- EU/1/04/294/012 20041022
>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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