Risedronate sodium - Generic Drug Details

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What are the generic drug sources for risedronate sodium and what is the scope of freedom to operate?

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

Risedronate sodium has eighty-four patent family members in thirty-three countries.

There are seventeen drug master file entries for risedronate sodium. Thirteen suppliers are listed for this compound.

Summary for risedronate sodium

International Patents:	84
US Patents:	3
Tradenames:	3
Applicants:	12
NDAs:	16
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	87
Clinical Trials:	16
Patent Applications:	3,588
Drug Prices:	Drug price trends for risedronate sodium
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for risedronate sodium
What excipients (inactive ingredients) are in risedronate sodium?	risedronate sodium excipients list
DailyMed Link:	risedronate sodium at DailyMed

See drug prices for risedronate sodium

Recent Clinical Trials for risedronate sodium

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

Sponsor	Phase
Sheffield Children's NHS Foundation Trust	Phase 2
Takeda
Chugai Pharmaceutical	Phase 3

See all risedronate sodium clinical trials

Pharmacology for risedronate sodium

Drug Class	Bisphosphonate

Medical Subject Heading (MeSH) Categories for risedronate sodium

Bone Density Conservation Agents
Calcium Channel Blockers

Paragraph IV (Patent) Challenges for RISEDRONATE SODIUM

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ATELVIA	Delayed-release Tablets	risedronate sodium	35 mg	022560	1	2011-06-09
ACTONEL	Tablets	risedronate sodium	150 mg	020835	1	2008-08-12
ACTONEL	Tablets	risedronate sodium	75 mg	020835	1	2007-09-07
ACTONEL	Tablets	risedronate sodium	5 mg, 30 mg and 35 mg	020835	1	2004-04-23

US Patents and Regulatory Information for risedronate sodium

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Glossary

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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
Aurobindo Pharma	RISEDRONATE SODIUM	risedronate sodium	TABLET;ORAL	206768-001	Oct 21, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Usa	RISEDRONATE SODIUM	risedronate sodium	TABLET;ORAL	079215-001	Jun 13, 2014	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Impax Labs Inc	RISEDRONATE SODIUM	risedronate sodium	TABLET, DELAYED RELEASE;ORAL	205066-001	Jun 29, 2018		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	RISEDRONATE SODIUM	risedronate sodium	TABLET;ORAL	200477-002	Nov 30, 2015		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apotex	RISEDRONATE SODIUM	risedronate sodium	TABLET;ORAL	090877-002	Jun 10, 2014	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-004	Apr 16, 2007		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-002	Apr 14, 2000	⤷ Sign Up	⤷ Sign Up
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-003	May 25, 2002	⤷ Sign Up	⤷ Sign Up
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-001	Mar 27, 1998	⤷ Sign Up	⤷ Sign Up
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-005	Apr 22, 2008	⤷ Sign Up	⤷ Sign Up
Apil	ACTONEL	risedronate sodium	TABLET;ORAL	020835-001	Mar 27, 1998	⤷ Sign Up	⤷ Sign Up
Apil	ATELVIA	risedronate sodium	TABLET, DELAYED RELEASE;ORAL	022560-001	Oct 8, 2010	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for risedronate sodium

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Country	Patent Number	Title	Estimated Expiration
Taiwan	200607514		⤷ Sign Up
Poland	2283825		⤷ Sign Up
South Africa	200609446	Enteric solid oral dosage form of bisphosphonate containing a chelating agent	⤷ Sign Up
Poland	1753395		⤷ Sign Up
China	101166519	Dosage forms of risedronate	⤷ Sign Up
Israel	268462	Dosage forms of risedronate	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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