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Baxter
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Boehringer Ingelheim
Harvard Business School

Last Updated: March 23, 2023

Apil Company Profile


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Summary for Apil
International Patents:161
US Patents:7
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 DIDRONEL etidronate disodium TABLET;ORAL 017831-002 Approved Prior to Jan 1, 1982 DISCN Yes No See Plans and Pricing See Plans and Pricing
Apil ESTROSTEP 21 ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 020130-001 Oct 9, 1996 DISCN Yes No See Plans and Pricing See Plans and Pricing
Apil DIDRONEL etidronate disodium TABLET;ORAL 017831-001 Approved Prior to Jan 1, 1982 DISCN Yes No See Plans and Pricing See Plans and Pricing
Apil NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ethinyl estradiol; norethindrone TABLET, CHEWABLE;ORAL 022573-001 Dec 22, 2010 AB RX Yes Yes See Plans and Pricing See Plans and Pricing
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-005 Apr 22, 2008 AB RX Yes Yes 7,718,634*PED See Plans and Pricing Y See Plans and Pricing
Apil NORCO acetaminophen; hydrocodone bitartrate TABLET;ORAL 040148-003 Sep 12, 2000 DISCN No No See Plans and Pricing See Plans and Pricing
Apil FEMTRACE estradiol acetate TABLET;ORAL 021633-002 Aug 20, 2004 DISCN Yes No 7,572,779 See Plans and Pricing See Plans and Pricing
>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 020835-001 Mar 27, 1998 6,015,801 See Plans and Pricing
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002 6,432,932*PED See Plans and Pricing
Apil NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ethinyl estradiol; norethindrone TABLET, CHEWABLE;ORAL 022573-001 Dec 22, 2010 5,552,394 See Plans and Pricing
Apil ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513-001 Dec 22, 2004 6,106,864 See Plans and Pricing
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-001 Mar 27, 1998 6,165,513*PED See Plans and Pricing
Apil FEMCON FE ethinyl estradiol; norethindrone TABLET;ORAL 021490-001 Nov 14, 2003 6,667,050 See Plans and Pricing
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-002 Apr 14, 2000 5,994,329 See Plans and Pricing
>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 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 Chewable Tablets 1 mg/0.02 mg and 75 mg ➤ Subscribe 2014-04-23
➤ Subscribe Delayed-release Capsules 400 mg ➤ Subscribe 2014-06-17
➤ 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

International Patents for Apil Drugs

Country Patent Number Estimated Expiration
World Intellectual Property Organization (WIPO) 03055495 See Plans and Pricing
World Intellectual Property Organization (WIPO) 2006115871 See Plans and Pricing
Cyprus 1116233 See Plans and Pricing
Israel 164371 See Plans and Pricing
Norway 20100477 See Plans and Pricing
Brazil PI0511530 See Plans and Pricing
Taiwan I347188 See Plans and Pricing
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for Apil Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0770388 PA2009004,C0770388 Lithuania See Plans and Pricing 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
1453521 132016000025143 Italy See Plans and Pricing PRODUCT NAME: LEVONORGESTREL ED ETINILESTRADIOLO(SEASONIQUE); AUTHORISATION NUMBER(S) AND DATE(S): 17/0017/15-S, 20150211;042139016, 20150414
0770388 PA2009004 Lithuania See Plans and Pricing 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
2782584 132021000000197 Italy See Plans and Pricing PRODUCT NAME: ESTRADIOLO (17SS-ESTRADIOLO) IN PARTICOLARE NELLA FORMA EMIIDRATA, E PROGESTERONE COMPRENDENTI LE VARIE FORME DI ESTRADIOLO (17SS-ESTRADIOLO), QUALI LE FORME IDRATE E SOLVATATE, INCLUDENDO LA FORMA EMIIDRATA, ED I SUOI SALI.(BIJUVA); AUTHORISATION NUMBER(S) AND DATE(S): BE582231, 20210406;048335018 -048335020, 20210517
2782584 301153 Netherlands See Plans and Pricing 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
0850059 22/2005 Austria See Plans and Pricing PRODUCT NAME: DARIFENACIN ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ HIEVON; REGISTRATION NO/DATE: EU/1/04/294/001- EU/1/04/294/012 20041022
1453521 122015000093 Germany See Plans and Pricing PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
>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

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.