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Serving leading biopharmaceutical companies globally:

Moodys
Farmers Insurance
AstraZeneca
US Department of Justice
Julphar
Citi
Covington
Novartis
Daiichi Sankyo
McKinsey

Generated: December 14, 2017

DrugPatentWatch Database Preview

Apil Company Profile

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What is the competitive landscape for APIL, and when can generic versions of APIL drugs launch?

APIL has twenty-six approved drugs.

There are twenty-one US patents protecting APIL drugs.

There are three hundred and seventy-six patent family members on APIL drugs in fifty-four countries and forty-six supplementary protection certificates in eleven countries.

Summary for Apil

International Patents:376
US Patents:21
Tradenames:27
Ingredients:10
NDAs:26
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
ApilASACOL HDmesalamineTABLET, DELAYED RELEASE;ORAL021830-001May 29, 2008ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
ApilENABLEXdarifenacin hydrobromideTABLET, EXTENDED RELEASE;ORAL021513-001Dec 22, 2004ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
ApilENABLEXdarifenacin hydrobromideTABLET, EXTENDED RELEASE;ORAL021513-002Dec 22, 2004ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
ApilFEMTRACEestradiol acetateTABLET;ORAL021633-001Aug 20, 2004DISCNYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
ApilSARAFEMfluoxetine hydrochlorideTABLET;ORAL021860-002May 19, 2006AB1RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
ApilASACOL HDmesalamineTABLET, DELAYED RELEASE;ORAL021830-001May 29, 2008ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
ApilFEMTRACEestradiol acetateTABLET;ORAL021633-001Aug 20, 2004DISCNYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
ApilACTONELrisedronate sodiumTABLET;ORAL020835-001Mar 27, 1998ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
ApilFEMTRACEestradiol acetateTABLET;ORAL021633-001Aug 20, 2004DISCNYesNo► Subscribe► Subscribe► Subscribe► Subscribe
ApilLOESTRIN 24 FEethinyl estradiol; norethindrone acetateTABLET;ORAL021871-001Feb 17, 2006ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Patents for Apil

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
ApilATELVIArisedronate sodiumTABLET, DELAYED RELEASE;ORAL022560-001Oct 8, 2010► Subscribe► Subscribe
ApilESTROSTEP FEethinyl estradiol; norethindrone acetateTABLET;ORAL-28020130-002Oct 9, 1996► Subscribe► Subscribe
ApilDIDRONELetidronate disodiumTABLET;ORAL017831-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
ApilACTONELrisedronate sodiumTABLET;ORAL020835-004Apr 16, 2007► Subscribe► Subscribe
ApilESTROSTEP 21ethinyl estradiol; norethindrone acetateTABLET;ORAL-21020130-001Oct 9, 1996► Subscribe► Subscribe
ApilACTONELrisedronate sodiumTABLET;ORAL020835-003May 25, 2002► Subscribe► Subscribe
ApilASACOL HDmesalamineTABLET, DELAYED RELEASE;ORAL021830-001May 29, 2008► Subscribe► Subscribe
ApilDELZICOLmesalamineCAPSULE, DELAYED RELEASE;ORAL204412-001Feb 1, 2013► Subscribe► Subscribe
ApilDIDRONELetidronate disodiumTABLET;ORAL017831-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
ApilENABLEXdarifenacin hydrobromideTABLET, EXTENDED RELEASE;ORAL021513-001Dec 22, 2004► Subscribe► Subscribe
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Paragraph IV activity for APIL drugs

Drugname Dosage Strength Tradename Submissiondate
mesalamineDelayed-release Capsules400 mgDELZICOL6/17/2014
norethindrone acetate and ethinyl estradiol and ferrous fumarateChewable Tablets1 mg/0.02 mg and 75 mgMINASTRIN 24 FE4/23/2014
risedronate sodiumDelayed-release Tablets35 mgATELVIA7/19/2011
mesalamineDelayed-release Tablets800 mgASACOL HD7/13/2011
darifenacin hydrobromideExtended-release Tablets7.5 mg and 15 mgENABLEX12/22/2008
risedronate sodiumTablets150 mgACTONEL8/12/2008
risedronate sodiumTablets75 mgACTONEL9/10/2007
mesalamineDelayed-release Tablets400 mgASACOL6/22/2007
norethindrone and ethinyl estradiol and ferrous fumarateChewable Tablets0.4 mg/0.035 mgFEMCON FE4/27/2007
norethindrone acetate/ ethinyl estradiol and ferrous fumarateTablets1 mg/0.02 mg and 75 mgLOESTRIN 24 FE4/17/2006
risedronate sodiumTablets5 mg, 30 mg and 35 mgACTONEL4/23/2004

Non-Orange Book 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
8,535,718Dosage forms of bisphosphonates► Subscribe
6,569,460 Film-coated tablet for improved upper gastrointestinal tract safety► Subscribe
8,409,614Low dosage forms of risedronate or its salts► Subscribe
6,225,294 Method for inhibiting bone resorption► Subscribe
6,544,967 Method for inhibiting bone resorption► Subscribe
8,409,615Low dosage forms of risedronate or its salts► Subscribe
6,333,316 Method for inhibiting bone resorption► Subscribe
7,410,957Method of treatment using bisphosphonic acid► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Apil Drugs

Country Document Number Estimated Expiration
Bulgaria104093► Subscribe
World Intellectual Property Organization (WIPO)2006115871► Subscribe
Malaysia140080► Subscribe
South Africa9607745► Subscribe
Spain2188782► Subscribe
Norway20065969► Subscribe
Australia4049400► Subscribe
Spain2349584► Subscribe
Slovenia1173153► Subscribe
Mexico9802026► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Apil Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2005Austria► SubscribePRODUCT NAME: DARIFENACIN ODER EIN PHARMAZEUTISCH ANNEHEMBARES SALZ HIEVON; REGISTRATION NO/DATE: EU/1/04/294/001 - EU/1/04/294/012 20041022
00221Netherlands► SubscribePRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
C0002Belgium► SubscribePRODUCT NAME: ESTRADIOL; NAT. REGISTRATION NO/DATE: NL 18978 19960731; FIRST REGISTRATION: SE - 11783 19930305
2009Austria► SubscribePRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103
00191Netherlands► SubscribePRODUCT 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
C/GB09/026United Kingdom► SubscribePRODUCT NAME: ESTRADIOL AND COMBINATIONS OF ESTRADIOL AND DIENOGEST, PREFERABLY ESTRADIOL VALERATE AND COMBINATIONS OF ESTRADIOL VALERATE AND DIENOGEST; REGISTERED: BE BE 327792 20081103; UK PL 00010/0576-0001 20081208
2006002Lithuania► SubscribePRODUCT 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
09/012Ireland► SubscribePRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103
/2015Austria► SubscribePRODUCT NAME: ETHINYLESTRADIOL UND EINE KOMBINATION VON LEVONORGESTREL UND ETHINYLESTRADIOL; NAT. REGISTRATION NO/DATE: 136021 20150224; FIRST REGISTRATION: SK 17/0017/15-S 20150211
C0003Belgium► SubscribePRODUCT NAME: ESTRADIOL AND NORETHISTERONE; FIRST REGISTRATION NO/DATE: 403 IS 106 F3 19980928; FIRST REGISTRATION: SE 14007 19980306
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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Serving leading biopharmaceutical companies globally:

Moodys
Merck
Healthtrust
AstraZeneca
Covington
Daiichi Sankyo
Cipla
Julphar
Queensland Health
Cantor Fitzgerald

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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