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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Julphar
Baxter
Covington
US Department of Justice
Moodys
Fish and Richardson
Harvard Business School
Cerilliant

Generated: August 14, 2018

DrugPatentWatch Database Preview

Apil Company Profile

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Summary for Apil
International Patents:332
US Patents:20
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 LOESTRIN 21 1/20 ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 017876-001 Approved Prior to Jan 1, 1982 AB RX No No ➤ Sign Up ➤ Sign Up
Apil FEMTRACE estradiol acetate TABLET;ORAL 021633-003 Aug 20, 2004 DISCN Yes No 7,572,779 ➤ Sign Up ➤ Sign Up
Apil SARAFEM fluoxetine hydrochloride TABLET;ORAL 021860-001 May 19, 2006 AB1 RX Yes No ➤ Sign Up ➤ Sign Up
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002 AB RX Yes Yes 6,015,801*PED ➤ Sign Up Y ➤ 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 DIDRONEL etidronate disodium TABLET;ORAL 017831-001 Approved Prior to Jan 1, 1982 4,137,309 ➤ Sign Up
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-002 Apr 14, 2000 5,583,122*PED ➤ Sign Up
Apil MINASTRIN 24 FE ethinyl estradiol; norethindrone acetate TABLET, CHEWABLE;ORAL 203667-001 May 8, 2013 5,552,394 ➤ Sign Up
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-001 Mar 27, 1998 6,015,801 ➤ 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 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
➤ 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

Non-Orange Book US Patents for Apil

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,409,614 Low dosage forms of risedronate or its salts ➤ Sign Up
6,225,294 Method for inhibiting bone resorption ➤ Sign Up
7,410,957 Method of treatment using bisphosphonic acid ➤ Sign Up
6,569,460 Film-coated tablet for improved upper gastrointestinal tract safety ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for Apil Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
156 Luxembourg ➤ Sign Up PRODUCT NAME: LEVONORGESTREL ET ETHINYLESTRADIOL; FIRST REGISTRATION DATE: 20150211
364 Luxembourg ➤ Sign Up 91364, EXPIRES: 20200826
00C/027 Belgium ➤ Sign Up PRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
/2005 Austria ➤ Sign Up PRODUCT NAME: DARIFENACIN ODER EIN PHARMAZEUTISCH ANNEHEMBARES SALZ HIEVON; REGISTRATION NO/DATE: EU/1/04/294/001 - EU/1/04/294/012 20041022
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:

Argus Health
Colorcon
AstraZeneca
Teva
Mallinckrodt
QuintilesIMS
Medtronic
US Army
Farmers Insurance

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 verifification 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.