Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

AstraZeneca
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Last Updated: November 20, 2019

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Apil Company Profile

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Summary for Apil
International Patents:301
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 ACTONEL risedronate sodium TABLET;ORAL 020835-004 Apr 16, 2007 DISCN Yes No   Start Trial   Start Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-005 Apr 22, 2008 AB RX Yes Yes 7,718,634*PED   Start Trial Y   Start Trial
Apil FEMCON FE ethinyl estradiol; norethindrone TABLET, CHEWABLE;ORAL 021490-001 Nov 14, 2003 DISCN Yes No 6,667,050   Start Trial Y   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 020835-001 Mar 27, 1998 6,096,342*PED   Start Trial
Apil ESTROSTEP 21 ethinyl estradiol; norethindrone acetate TABLET;ORAL-21 020130-001 Oct 9, 1996 4,962,098   Start Trial
Apil LOESTRIN 24 FE ethinyl estradiol; norethindrone acetate TABLET;ORAL 021871-001 Feb 17, 2006 5,552,394   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 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
➤ Subscribe Chewable Tablets 0.4 mg/0.035 mg ➤ Subscribe 2007-04-27

Supplementary Protection Certificates for Apil Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0285237 95C0008 Belgium   Start Trial PRODUCT NAME: ESTRADIOL, HEMIHYDRATE; NAT. REGISTRATION NO/DATE: NL 19489 19941107; FIRST REGISTRATION: FR - NL 19489 19941107
1380301 CA 2009 00017 Denmark   Start Trial PRODUCT NAME: ETHINYLESTRADIOL (SOM BETADEXCLATHRAT) OG DROSPIRENON; NAT. REG. NO/DATE: 42417 (DK) 20080619; FIRST REG. NO/DATE: NL 33842 20070629
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
>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:

Dow
Harvard Business School
Colorcon
McKesson
Johnson and Johnson
AstraZeneca

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.