➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

McKinsey
Mallinckrodt
McKesson
Express Scripts
Medtronic
Boehringer Ingelheim

Last Updated: October 17, 2021

DrugPatentWatch Database Preview

Risedronate sodium - Generic Drug Details

➤ Get the DrugPatentWatch Daily Briefing

« Back to Dashboard

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

Risedronate sodium is the generic ingredient in three branded drugs marketed by Apil, Impax Labs Inc, Sun Pharm, Teva Pharms Usa, Zydus Pharms, Apotex Inc, Aurobindo Pharma Ltd, Hangzhou Binjiang, Macleods Pharms Ltd, Mylan, and Orchid Hlthcare, and is included in sixteen NDAs. There are five patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Risedronate sodium has one hundred and forty-nine patent family members in thirty-six countries.

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

Drug Prices for risedronate sodium

See drug prices for risedronate sodium

Recent Clinical Trials for risedronate sodium

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Sheffield Children's NHS Foundation TrustPhase 2
TakedaN/A
Chugai PharmaceuticalPhase 3

See all risedronate sodium clinical trials

Pharmacology for risedronate sodium
Drug ClassBisphosphonate
Medical Subject Heading (MeSH) Categories for risedronate sodium
Paragraph IV (Patent) Challenges for RISEDRONATE SODIUM
Tradename Dosage Ingredient NDA Submissiondate
ATELVIA TABLET, DELAYED RELEASE;ORAL risedronate sodium 022560 2011-06-09
ACTONEL TABLET;ORAL risedronate sodium 020835 2008-08-12
ACTONEL TABLET;ORAL risedronate sodium 020835 2007-09-10
ACTONEL TABLET;ORAL risedronate sodium 020835 2007-09-07
ACTONEL TABLET;ORAL risedronate sodium 020835 2004-04-23

US Patents and Regulatory Information for risedronate sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-005 Apr 22, 2008 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Apil ATELVIA risedronate sodium TABLET, DELAYED RELEASE;ORAL 022560-001 Oct 8, 2010 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Aurobindo Pharma Ltd RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 200296-003 Nov 30, 2015 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Apil ATELVIA risedronate sodium TABLET, DELAYED RELEASE;ORAL 022560-001 Oct 8, 2010 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Macleods Pharms Ltd RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 203533-003 Nov 29, 2016 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Macleods Pharms Ltd RISEDRONATE SODIUM risedronate sodium TABLET;ORAL 203533-002 Dec 9, 2015 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for risedronate sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-001 Mar 27, 1998 ⤷  Try it Free ⤷  Try it Free
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002 ⤷  Try it Free ⤷  Try it Free
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-001 Mar 27, 1998 ⤷  Try it Free ⤷  Try it Free
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-001 Mar 27, 1998 ⤷  Try it Free ⤷  Try it Free
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-001 Mar 27, 1998 ⤷  Try it Free ⤷  Try it Free
Apil ATELVIA risedronate sodium TABLET, DELAYED RELEASE;ORAL 022560-001 Oct 8, 2010 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKinsey
Mallinckrodt
McKesson
Express Scripts
Medtronic
Boehringer Ingelheim

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 verification 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.