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Generated: August 18, 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.

Summary for Applicant: Apil

Patents:21
Tradenames:27
Ingredients:10
NDAs:26
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;ORAL020835-004Apr 16, 2007DISCNYesNo► Subscribe► SubscribeY► Subscribe
Apil
LOESTRIN 21 1.5/30
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21017875-001Approved Prior to Jan 1, 1982ABRXNoNo► Subscribe► Subscribe► Subscribe
Apil
DELZICOL
mesalamine
CAPSULE, DELAYED RELEASE;ORAL204412-001Feb 1, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Apil
SARAFEM
fluoxetine hydrochloride
TABLET;ORAL021860-002May 19, 2006AB1RXYesNo► Subscribe► Subscribe► Subscribe
Apil
NORCO
acetaminophen; hydrocodone bitartrate
TABLET;ORAL040099-001Jun 25, 1997AARXNoYes► Subscribe► Subscribe► Subscribe
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Expired Patents for Apil

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil
DIDRONEL
etidronate disodium
TABLET;ORAL017831-002Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Apil
ENABLEX
darifenacin hydrobromide
TABLET, EXTENDED RELEASE;ORAL021513-002Dec 22, 2004► Subscribe► Subscribe
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-003May 25, 2002► Subscribe► Subscribe
Apil
ASACOL
mesalamine
TABLET, DELAYED RELEASE;ORAL019651-001Jan 31, 1992► Subscribe► Subscribe
Apil
DIDRONEL
etidronate disodium
TABLET;ORAL017831-002Approved Prior to Jan 1, 1982► Subscribe► Subscribe
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Paragraph IV activity for APIL drugs

Drugname Dosage Strength Tradename Submissiondate
mesalamine
Delayed-release Capsules400 mg
DELZICOL
6/17/2014
norethindrone acetate and ethinyl estradiol and ferrous fumarate
Chewable Tablets1 mg/0.02 mg and 75 mg
MINASTRIN 24 FE
4/23/2014
risedronate sodium
Delayed-release Tablets35 mg
ATELVIA
7/19/2011
mesalamine
Delayed-release Tablets800 mg
ASACOL HD
7/13/2011
darifenacin hydrobromide
Extended-release Tablets7.5 mg and 15 mg
ENABLEX
12/22/2008
risedronate sodium
Tablets150 mg
ACTONEL
8/12/2008
risedronate sodium
Tablets75 mg
ACTONEL
9/10/2007
mesalamine
Delayed-release Tablets400 mg
ASACOL
6/22/2007
norethindrone and ethinyl estradiol and ferrous fumarate
Chewable Tablets0.4 mg/0.035 mg
FEMCON FE
4/27/2007
norethindrone acetate/ ethinyl estradiol and ferrous fumarate
Tablets1 mg/0.02 mg and 75 mg
LOESTRIN 24 FE
4/17/2006
risedronate sodium
Tablets5 mg, 30 mg and 35 mg
ACTONEL
4/23/2004

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
8,409,614Low dosage forms of risedronate or its salts► Subscribe
6,225,294 Method for inhibiting bone resorption► Subscribe
7,410,957Method of treatment using bisphosphonic acid► Subscribe
6,569,460 Film-coated tablet for improved upper gastrointestinal tract safety► Subscribe
6,544,967 Method for inhibiting bone resorption► 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
Australia7446098► Subscribe
South Korea101070205► Subscribe
Netherlands300223► Subscribe
Germany122007000063► Subscribe
United Kingdom2336311► 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
1214076/01Switzerland► SubscribePRODUCT NAME: DROSPIRENONE + ETHINYLESTRADIOL; REGISTRATION NUMBER/DATE: SWISSMEDIC 57946 13.06.2008
00C/027Belgium► SubscribePRODUCT NAME: ETHINYLESTRADIOLUM / NORETHISTERONI ACETAS; NAT. REGISTRATION NO/DATE: 19 IS 106 F3 20000911; FIRST REGISTRATION: NL RVG 23909 19991124
C/GB05/022United Kingdom► SubscribePRODUCT NAME: DARIFENACIN HYDROBROMIDE; REGISTERED: UK EU/1/04/294/001 20041022; UK EU/1/04/294/002 20041022; UK EU/1/04/294/003 20041022; UK EU/1/04/294/004 20041022; UK EU/1/04/294/005 20041022; UK EU/1/04/294/006 20041022; UK EU/1/04/294/007 20041022; UK EU/1/04/294/008 20041022; UK EU/1/04/294/009 20041022; UK EU/1/04/294/010 20041022; UK EU/1/04/294/011 20041022; UK EU/1/04/294/012 20041022
1175904/01Switzerland► SubscribeFORMER OWNER: SCHERING CORPORATION, US
2005 00020Denmark► Subscribe
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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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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Argus Health
QuintilesIMS
Accenture
Novartis
Daiichi Sankyo
Medtronic
Mallinckrodt
Deloitte
US Army
Fish and Richardson

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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