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Generated: May 26, 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

Drug Master File Entries: see list19
Suppliers / Packagers: see list12
Bulk Api Vendors: see list125
Clinical Trials: see list953
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

Drug ClassBisphosphonate

Tentative approvals for RISEDRONATE SODIUM

Applicant Application No. Strength Dosage Form
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Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Pharms Inc
risedronate sodium
TABLET;ORAL200477-001Nov 30, 2015ABRXNoNo► Subscribe► Subscribe
risedronate sodium
TABLET;ORAL020835-005Apr 22, 2008ABRXYesYes7,192,938*PED► SubscribeY► Subscribe
Apotex Inc
risedronate sodium
TABLET;ORAL090877-003Jun 10, 2014ABRXNoNo► Subscribe► Subscribe
Teva Pharms Usa
risedronate sodium
TABLET;ORAL077132-002Oct 5, 2007ABRXNoNo► Subscribe► Subscribe
risedronate sodium
TABLET, DELAYED RELEASE;ORAL022560-001Oct 8, 2010ABRXYesYes7,645,460► SubscribeY ► Subscribe
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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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