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Generated: October 21, 2017

DrugPatentWatch Database Preview

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 ten 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 seventy-five patent family members in fifty-two countries and nine supplementary protection certificates in five 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

US Patents:10
Tradenames:3
Applicants:7
NDAs:11
Drug Master File Entries: see list19
Suppliers / Packagers: see list12
Bulk Api Vendors: see list125
Clinical Trials: see list2,482
Patent Applications: see list5,122
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
u► Subscribe30MGTABLET;ORAL
u► Subscribe35MGTABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva Pharms Usa
RISEDRONATE SODIUM
risedronate sodium
TABLET;ORAL077132-001Oct 5, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms Usa
RISEDRONATE SODIUM
risedronate sodium
TABLET, DELAYED RELEASE;ORAL203217-001May 18, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Apotex Inc
RISEDRONATE SODIUM
risedronate sodium
TABLET;ORAL090877-002Jun 10, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-005Apr 22, 2008ABRXYesYes► Subscribe► SubscribeY► Subscribe
Aurobindo Pharma Ltd
RISEDRONATE SODIUM
risedronate sodium
TABLET;ORAL200296-003Nov 30, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Aurobindo Pharma Ltd
RISEDRONATE SODIUM
risedronate sodium
TABLET;ORAL200296-001Nov 30, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
RISEDRONATE SODIUM
risedronate sodium
TABLET;ORAL200477-003Nov 30, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Macleods Pharms Ltd
RISEDRONATE SODIUM
risedronate sodium
TABLET;ORAL203533-001Dec 9, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-005Apr 22, 2008ABRXYesYes► Subscribe► SubscribeY► Subscribe
Mylan Pharms Inc
RISEDRONATE SODIUM
risedronate sodium
TABLET;ORAL200477-001Nov 30, 2015ABRXNoNo► Subscribe► Subscribe► 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
ACTONEL
risedronate sodium
TABLET;ORAL020835-003May 25, 2002► Subscribe► Subscribe
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-005Apr 22, 2008► Subscribe► Subscribe
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-004Apr 16, 2007► Subscribe► Subscribe
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-002Apr 14, 2000► Subscribe► Subscribe
Apil
ATELVIA
risedronate sodium
TABLET, DELAYED RELEASE;ORAL022560-001Oct 8, 2010► Subscribe► Subscribe
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-001Mar 27, 1998► Subscribe► Subscribe
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-004Apr 16, 2007► Subscribe► Subscribe
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-001Mar 27, 1998► Subscribe► Subscribe
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-003May 25, 2002► Subscribe► Subscribe
Apil
ACTONEL
risedronate sodium
TABLET;ORAL020835-002Apr 14, 2000► Subscribe► 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
6,544,967 Method for inhibiting bone resorption► 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
7,410,957Method of treatment using bisphosphonic acid► Subscribe
8,535,718Dosage forms of bisphosphonates► Subscribe
6,225,294 Method for inhibiting bone resorption► Subscribe
6,333,316 Method for inhibiting bone resorption► Subscribe
8,409,615Low dosage forms of risedronate or its salts► 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
Portugal1753395► Subscribe
Cyprus1108105► Subscribe
China1602880► Subscribe
China1166365► Subscribe
Russian Federation2359678► Subscribe
Hungary0004625► Subscribe
New Zealand556278► Subscribe
Australia2007211965► Subscribe
Bulgaria66282► Subscribe
South Korea20110018465► 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
222Luxembourg► Subscribe91222, EXPIRES: 20200824
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
2007 00045Denmark► Subscribe
364Luxembourg► Subscribe91364, EXPIRES: 20200826
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
1175904/01Switzerland► SubscribeFORMER OWNER: SCHERING CORPORATION, US
2007007Lithuania► SubscribePRODUCT NAME: ACIDUM ALENDRONICUM NATRIUM, COLECALCIFEROLUM; REGISTRATION NO/DATE: EU/1/05/310/001 2005 08 24 EU/1/05/310/002 2005 08 24 EU/1/05/310/003 2005 08 24 EU/1/05/310/004 2005 08 24 EU/1/05/310/00 20050824
2006002,C0998292Lithuania► 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
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Medtronic
QuintilesIMS
Baxter
Queensland Health
US Army
Cantor Fitzgerald
UBS
Chinese Patent Office
Novartis

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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