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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Harvard Business School
Mallinckrodt
Healthtrust
Citi
Baxter
McKesson
Chinese Patent Office
AstraZeneca
US Army

Generated: December 14, 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 Apil, Teva Pharms Usa, Apotex Inc, Aurobindo Pharma Ltd, Macleods Pharms Ltd, 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-three 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.

Pharmacology for risedronate sodium

Ingredient-typeDiphosphonates
Drug ClassBisphosphonate

Medical Subject Heading (MeSH) Categories for risedronate sodium

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 Patent Submitted Product Substance Delist Req. Exclusivity Expiration
ApilACTONELrisedronate sodiumTABLET;ORAL020835-004Apr 16, 2007DISCNYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Apotex IncRISEDRONATE SODIUMrisedronate sodiumTABLET;ORAL090877-002Jun 10, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Apotex IncRISEDRONATE SODIUMrisedronate sodiumTABLET;ORAL090877-003Jun 10, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Sun Pharma GlobalRISEDRONATE SODIUMrisedronate sodiumTABLET;ORAL090886-005Jun 10, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
ApilACTONELrisedronate sodiumTABLET;ORAL020835-005Apr 22, 2008ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Sun Pharma GlobalRISEDRONATE SODIUMrisedronate sodiumTABLET;ORAL090886-004Jun 10, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Aurobindo Pharma LtdRISEDRONATE SODIUMrisedronate sodiumTABLET;ORAL200296-002Nov 30, 2015ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Teva Pharms UsaRISEDRONATE SODIUMrisedronate sodiumTABLET;ORAL077132-001Oct 5, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
ApilATELVIArisedronate sodiumTABLET, DELAYED RELEASE;ORAL022560-001Oct 8, 2010ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Teva Pharms UsaRISEDRONATE SODIUMrisedronate sodiumTABLET, DELAYED RELEASE;ORAL203217-001May 18, 2015ABRXNoNo► Subscribe► 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
ApilACTONELrisedronate sodiumTABLET;ORAL020835-002Apr 14, 2000► Subscribe► Subscribe
ApilACTONELrisedronate sodiumTABLET;ORAL020835-004Apr 16, 2007► Subscribe► Subscribe
ApilACTONELrisedronate sodiumTABLET;ORAL020835-003May 25, 2002► Subscribe► Subscribe
ApilATELVIArisedronate sodiumTABLET, DELAYED RELEASE;ORAL022560-001Oct 8, 2010► Subscribe► Subscribe
ApilACTONELrisedronate sodiumTABLET;ORAL020835-005Apr 22, 2008► Subscribe► Subscribe
ApilACTONELrisedronate sodiumTABLET;ORAL020835-002Apr 14, 2000► Subscribe► Subscribe
ApilACTONELrisedronate sodiumTABLET;ORAL020835-001Mar 27, 1998► Subscribe► Subscribe
ApilACTONELrisedronate sodiumTABLET;ORAL020835-001Mar 27, 1998► Subscribe► Subscribe
ApilACTONELrisedronate sodiumTABLET;ORAL020835-003May 25, 2002► Subscribe► Subscribe
ApilACTONELrisedronate sodiumTABLET;ORAL020835-004Apr 16, 2007► 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
6,225,294 Method for inhibiting bone resorption► Subscribe
8,409,614Low 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
7,410,957Method of treatment using bisphosphonic acid► Subscribe
8,535,718Dosage forms of bisphosphonates► Subscribe
8,409,615Low dosage forms of risedronate or its salts► 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 Ingredient: risedronate sodium

Country Document Number Estimated Expiration
Australia2003229770► Subscribe
Argentina061845► Subscribe
Bulgaria104093► Subscribe
Peru82999► Subscribe
Japan2009132709► Subscribe
Russian Federation2008103617► Subscribe
MexicoPA04009586► Subscribe
European Patent Office1753395► Subscribe
European Patent Office2851105► Subscribe
New Zealand501807► 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
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
1175904/01Switzerland► SubscribeFORMER OWNER: SCHERING CORPORATION, US
364Luxembourg► Subscribe91364, EXPIRES: 20200826
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
2007 00045Denmark► 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
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
2006 00005Denmark► Subscribe
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Serving leading biopharmaceutical companies globally:

US Department of Justice
Julphar
Moodys
Argus Health
Colorcon
Boehringer Ingelheim
Johnson and Johnson
Merck
Federal Trade Commission
US Army

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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