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Serving leading biopharmaceutical companies globally:

Novartis
Cipla
Queensland Health
US Army
QuintilesIMS
US Department of Justice
Fish and Richardson
Baxter
McKinsey
Johnson and Johnson

Generated: October 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-seven patent family members on APIL drugs in fifty-four countries and forty-five supplementary protection certificates in eleven countries.

Summary for Applicant: Apil

International Patents:377
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 Product Substance Delist Req. Exclusivity Expiration
Apil
LOESTRIN 21 1.5/30
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21017875-001Approved Prior to Jan 1, 1982ABRXNoNo► Subscribe► Subscribe► Subscribe
Apil
ASACOL
mesalamine
TABLET, DELAYED RELEASE;ORAL019651-001Jan 31, 1992DISCNNoNo► Subscribe► Subscribe► Subscribe
Apil
FEMCON FE
ethinyl estradiol; norethindrone
TABLET, CHEWABLE;ORAL021490-001Nov 14, 2003ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Apil
ESTROSTEP FE
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-28020130-002Oct 9, 1996ABRXYesYes► Subscribe► Subscribe► Subscribe
Apil
ASACOL HD
mesalamine
TABLET, DELAYED RELEASE;ORAL021830-001May 29, 2008ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Apil
FEMHRT
ethinyl estradiol; norethindrone acetate
TABLET;ORAL021065-001Jan 14, 2005ABRXNoNo► Subscribe► Subscribe► Subscribe
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-005Apr 22, 2008ABRXYesYes► Subscribe► SubscribeY► Subscribe
Apil
FEMTRACE
estradiol acetate
TABLET;ORAL021633-001Aug 20, 2004DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Apil
NORCO
acetaminophen; hydrocodone bitartrate
TABLET;ORAL040148-001Feb 14, 1997AARXNoYes► Subscribe► Subscribe► Subscribe
Apil
LOESTRIN 21 1/20
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21017876-001Approved Prior to Jan 1, 1982ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Patents for Apil

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil
FEMRING
estradiol acetate
INSERT, EXTENDED RELEASE;VAGINAL021367-001Mar 20, 2003► Subscribe► Subscribe
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-002Apr 14, 2000► Subscribe► Subscribe
Apil
ENABLEX
darifenacin hydrobromide
TABLET, EXTENDED RELEASE;ORAL021513-001Dec 22, 2004► Subscribe► Subscribe
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-001Mar 27, 1998► Subscribe► Subscribe
Apil
ESTROSTEP FE
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-28020130-002Oct 9, 1996► Subscribe► Subscribe
Apil
ESTROSTEP 21
ethinyl estradiol; norethindrone acetate
TABLET;ORAL-21020130-001Oct 9, 1996► Subscribe► Subscribe
Apil
FEMRING
estradiol acetate
INSERT, EXTENDED RELEASE;VAGINAL021367-002Mar 20, 2003► Subscribe► Subscribe
Apil
DIDRONEL
etidronate disodium
TABLET;ORAL017831-001Approved Prior to Jan 1, 1982► Subscribe► Subscribe
Apil
LO LOESTRIN FE
ethinyl estradiol; norethindrone acetate
TABLET;ORAL022501-001Oct 21, 2010► Subscribe► Subscribe
Apil
TAYTULLA
ethinyl estradiol; norethindrone acetate
CAPSULE;ORAL204426-001Apr 19, 2013► 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
8,535,718Dosage forms of bisphosphonates► Subscribe
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
6,544,967 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
6,569,460 Film-coated tablet for improved upper gastrointestinal tract safety► 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
BrazilPI0009373► Subscribe
Germany122005000024► Subscribe
Hong Kong1080409► Subscribe
Australia6406900► Subscribe
New Zealand316924► Subscribe
World Intellectual Property Organization (WIPO)9856360► Subscribe
Slovakia171899► Subscribe
South Korea20090106663► Subscribe
Russian Federation2193880► Subscribe
Turkey200102861► 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
C0005Belgium► SubscribePRODUCT NAME: ESTRADIOL HEMIHYDRAAT; NAT. REGISTRATION NO/DATE: 298 IS 190 F 15 19960806; FIRST REGISTRATION: GB PL/0053/0241 19950711
C0017France► SubscribePRODUCT 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
0850059/01Switzerland► SubscribeFORMER OWNER: NOVARTIS AG, CH
2009004Lithuania► SubscribePRODUCT 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
C/GB04/032United Kingdom► SubscribePRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310
C0018France► SubscribePRODUCT NAME: ESTRADIOL VALERATE; DIENOGEST; NAT. REGISTRATION NO/DATE: NL35170 20081210; FIRST REGISTRATION: BE327792 20081103
00221Netherlands► SubscribePRODUCT NAME: DROSPIRENON EN ETHINYLESTRADIOL; REGISTRATION NO/DATE: RVG 23827 20000307
/2004Austria► SubscribePRODUCT NAME: DROSPIRENON IN KOMBINATION MIT ESTRADIOL; NAT. REGISTRATION NO/DATE: 1-25178, 1-25179 20031127; FIRST REGISTRATION: NL RVG 27505 20021211
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
1175904/01Switzerland► SubscribeFORMER OWNER: SCHERING CORPORATION, US
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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 leading biopharmaceutical companies globally:

Accenture
Chubb
Covington
Express Scripts
Argus Health
Dow
Healthtrust
Medtronic
Citi
Baxter

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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