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Serving 500+ biopharmaceutical companies globally:

Teva
US Department of Justice
Cantor Fitzgerald
Deloitte
AstraZeneca
Moodys
Colorcon
QuintilesIMS
Queensland Health
Healthtrust

Generated: July 21, 2017

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Risedronate sodium - Generic Drug Details

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What are the generic drug sources for risedronate sodium and what is the scope of risedronate sodium patent protection?

Risedronate sodium
is the generic ingredient in three branded drugs marketed by Teva Pharms Usa, Macleods Pharms Ltd, Apil, Aurobindo Pharma Ltd, Apotex Inc, Mylan Pharms Inc, and Sun Pharma Global, and is included in eleven NDAs. There are eleven patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Risedronate sodium has two hundred and fifty-eight patent family members in fifty-two countries.

There are nineteen drug master file entries for risedronate sodium. Twelve suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: risedronate sodium

Tradenames:3
Patents:11
Applicants:7
NDAs:11
Drug Master File Entries: see list19
Suppliers / Packagers: see list12
Bulk Api Vendors: see list125
Clinical Trials: see list2,431
Patent Applications: see list4,824
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:risedronate sodium at DailyMed

Pharmacology for Ingredient: risedronate sodium

Ingredient-typeDiphosphonates
Drug ClassBisphosphonate

Tentative approvals for RISEDRONATE SODIUM

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe30MGTABLET;ORAL
► Subscribe► Subscribe35MGTABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharma Global
RISEDRONATE SODIUM
risedronate sodium
TABLET;ORAL090886-003Nov 30, 2015ABRXNoNo► Subscribe► Subscribe
Teva Pharms Usa
RISEDRONATE SODIUM
risedronate sodium
TABLET, DELAYED RELEASE;ORAL203217-001May 18, 2015ABRXNoNo► Subscribe► Subscribe
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-005Apr 22, 2008ABRXYesYes7,192,938*PED► SubscribeY► Subscribe
Sun Pharma Global
RISEDRONATE SODIUM
risedronate sodium
TABLET;ORAL090886-004Jun 10, 2014ABRXNoNo► Subscribe► Subscribe
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-003May 25, 2002ABRXYesYes6,015,801*PED► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: risedronate sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil
ATELVIA
risedronate sodium
TABLET, DELAYED RELEASE;ORAL022560-001Oct 8, 20105,583,122*PED► Subscribe
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-003May 25, 20025,583,122*PED► Subscribe
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-003May 25, 20026,096,342*PED► Subscribe
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-005Apr 22, 20085,583,122*PED► Subscribe
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-002Apr 14, 20005,583,122*PED► Subscribe
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Non-Orange Book Patents for Generic Ingredient: risedronate sodium

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
6,544,967 Method for inhibiting bone resorption► Subscribe
6,569,460 Film-coated tablet for improved upper gastrointestinal tract safety► Subscribe
8,535,718Dosage forms of bisphosphonates► 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 Ingredient: risedronate sodium

Country Document Number Estimated Expiration
Denmark0998292► Subscribe
Slovakia171899► Subscribe
Cyprus1111259► Subscribe
South Korea20070111551► Subscribe
Australia2010200438► 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 Tradename: RISEDRONATE SODIUM

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
2007 00045Denmark► Subscribe
2006 00005Denmark► Subscribe
00292Netherlands► SubscribePRODUCT 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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Chinese Patent Office
Chubb
Teva
Mallinckrodt
Baxter
Merck
Argus Health
Fish and Richardson
Dow
Julphar

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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