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Serving leading biopharmaceutical companies globally:

Baxter
Federal Trade Commission
Harvard Business School
US Department of Justice
Deloitte
Dow
Novartis
Cipla
Medtronic
Moodys

Generated: February 18, 2018

DrugPatentWatch Database Preview

Apil Company Profile

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Summary for Apil
International Patents:332
US Patents:20
Tradenames:27
Ingredients:10
NDAs:26

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 NORCO acetaminophen; hydrocodone bitartrate TABLET;ORAL 040148-004 Jul 7, 2014 AA RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Apil LOESTRIN FE 1/20 ethinyl estradiol; norethindrone acetate TABLET;ORAL-28 017354-001 Approved Prior to Jan 1, 1982 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial
Apil NOR-QD norethindrone TABLET;ORAL-28 017060-001 Approved Prior to Jan 1, 1982 AB1 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-005 Apr 22, 2008 AB RX Yes Yes 7,192,938*PED ➤ Try a Free Trial Y ➤ Try a Free Trial
Apil ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513-001 Dec 22, 2004 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002 AB RX Yes Yes 6,165,513*PED ➤ Try a Free Trial Y ➤ Try a Free Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002 AB RX Yes Yes 6,015,801*PED ➤ Try a Free Trial Y ➤ Try a Free Trial
Apil FEMHRT ethinyl estradiol; norethindrone acetate TABLET;ORAL 021065-001 Jan 14, 2005 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial
Apil SARAFEM fluoxetine hydrochloride TABLET;ORAL 021860-001 May 19, 2006 AB1 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial
Apil DELZICOL mesalamine CAPSULE, DELAYED RELEASE;ORAL 204412-001 Feb 1, 2013 RX Yes Yes 6,649,180 ➤ Try a Free Trial Y ➤ Try a Free Trial
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 020835-005 Apr 22, 2008 5,583,122*PED ➤ Try a Free Trial
Apil FEMRING estradiol acetate INSERT, EXTENDED RELEASE;VAGINAL 021367-001 Mar 20, 2003 5,855,906 ➤ Try a Free Trial
Apil ENABLEX darifenacin hydrobromide TABLET, EXTENDED RELEASE;ORAL 021513-002 Dec 22, 2004 5,096,890 ➤ Try a Free Trial
Apil ATELVIA risedronate sodium TABLET, DELAYED RELEASE;ORAL 022560-001 Oct 8, 2010 5,622,721 ➤ Try a Free Trial
Apil ASACOL HD mesalamine TABLET, DELAYED RELEASE;ORAL 021830-001 May 29, 2008 5,541,170 ➤ Try a Free Trial
Apil ASACOL mesalamine TABLET, DELAYED RELEASE;ORAL 019651-001 Jan 31, 1992 5,541,171 ➤ Try a Free Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-001 Mar 27, 1998 5,583,122*PED ➤ Try a Free Trial
Apil ASACOL mesalamine TABLET, DELAYED RELEASE;ORAL 019651-001 Jan 31, 1992 5,541,170 ➤ Try a Free Trial
Apil DIDRONEL etidronate disodium TABLET;ORAL 017831-002 Approved Prior to Jan 1, 1982 3,683,080 ➤ Try a Free Trial
Apil DELZICOL mesalamine CAPSULE, DELAYED RELEASE;ORAL 204412-001 Feb 1, 2013 5,541,170 ➤ Try a Free Trial
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 6/17/2014
➤ Subscribe Chewable Tablets 1 mg/0.02 mg and 75 mg ➤ Subscribe 4/23/2014
➤ Subscribe Delayed-release Tablets 35 mg ➤ Subscribe 7/19/2011
➤ Subscribe Delayed-release Tablets 800 mg ➤ Subscribe 7/13/2011
➤ Subscribe Extended-release Tablets 7.5 mg and 15 mg ➤ Subscribe 12/22/2008
➤ Subscribe Tablets 150 mg ➤ Subscribe 8/12/2008
➤ Subscribe Tablets 75 mg ➤ Subscribe 9/10/2007
➤ Subscribe Delayed-release Tablets 400 mg ➤ Subscribe 6/22/2007
➤ Subscribe Chewable Tablets 0.4 mg/0.035 mg ➤ Subscribe 4/27/2007
➤ Subscribe Tablets 1 mg/0.02 mg and 75 mg ➤ Subscribe 4/17/2006
➤ Subscribe Tablets 5 mg, 30 mg and 35 mg ➤ Subscribe 4/23/2004

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
8,409,615 Low dosage forms of risedronate or its salts ➤ Try a Free Trial
8,535,718 Dosage forms of bisphosphonates ➤ Try a Free Trial
6,225,294 Method for inhibiting bone resorption ➤ Try a Free Trial
6,333,316 Method for inhibiting bone resorption ➤ Try a Free Trial
7,410,957 Method of treatment using bisphosphonic acid ➤ Try a Free Trial
6,544,967 Method for inhibiting bone resorption ➤ Try a Free Trial
8,409,614 Low dosage forms of risedronate or its salts ➤ Try a Free Trial
6,569,460 Film-coated tablet for improved upper gastrointestinal tract safety ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for Apil Drugs

Supplementary Protection Certificates for Apil Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2009004,C0770388 Lithuania ➤ Try a Free Trial 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
2006002,C0998292 Lithuania ➤ Try a Free Trial 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
C0008 Belgium ➤ Try a Free Trial PRODUCT NAME: ESTRADIOL, HEMIHYDRATE; NAT. REGISTRATION NO/DATE: NL 19489 19941107; FIRST REGISTRATION: FR - NL 19489 19941107
00292 Netherlands ➤ Try a Free 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
C0018 France ➤ Try a Free Trial PRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
0136011/03 Switzerland ➤ Try a Free Trial PRODUCT NMAE: ESTRADIOL UND MEDROXYPROGESTERONACETAT; REGISTRATION NO/DATE: IKS 55288 20000417
1214076/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
00191 Netherlands ➤ Try a Free Trial PRODUCT NAME: DARIFENACINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROBROMIDE; REGISTRATION NO/DATE: EU1/04/294/001 - 012, 20041022
2015000093 Germany ➤ Try a Free Trial PRODUCT NAME: LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 87675.00.00 20150720; FIRST REGISTRATION: SLOWAKEI 17/0017/15-S 20150129
2006 00038 Denmark ➤ Try a Free Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETA-CYCLODEXTRIN-CLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 38687 20060627; FIRST REG. NO/DATE: EU RVG 31781 20050804
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.

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Deloitte
Colorcon
Johnson and Johnson
Dow
Medtronic
Mallinckrodt
Queensland Health
Federal Trade Commission

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.

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