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Ibandronate sodium - Generic Drug Details

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

Ibandronate sodium is the generic ingredient in two branded drugs marketed by Roche, Accord Hlthcare, Apotex, Aurobindo Pharma Ltd, Emcure Pharms Ltd, Mylan Labs Ltd, Nang Kuang Pharm Co, Sagent Pharms Inc, Sun Pharm, Hoffmann La Roche, Apotex Inc, Dr Reddys Labs Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Orchid Hlthcare, Sun Pharm Industries, and Watson Labs Teva, and is included in eighteen NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ibandronate sodium has seventy-one patent family members in thirty-two countries.

There are sixteen drug master file entries for ibandronate sodium. Eleven suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for ibandronate sodium

International Patents:	71
US Patents:	3
Tradenames:	2
Applicants:	17
NDAs:	18
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	11
Raw Ingredient (Bulk) Api Vendors:	143
Clinical Trials:	4
Patent Applications:	69
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for ibandronate sodium
What excipients (inactive ingredients) are in ibandronate sodium?	ibandronate sodium excipients list
DailyMed Link:	ibandronate sodium at DailyMed

See drug prices for ibandronate sodium

Recent Clinical Trials for ibandronate sodium

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

Sponsor	Phase
Dr. Reddy's Laboratories Limited	Phase 1
National Cancer Institute (NCI)	Phase 3
Southwest Oncology Group	Phase 3

See all ibandronate sodium clinical trials

Generic filers with tentative approvals for IBANDRONATE SODIUM

Applicant	Application No.	Strength	Dosage Form
		2.5MG	TABLET; ORAL
		1MG	INJECTABLE; INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for ibandronate sodium

Drug Class

Bisphosphonate

Paragraph IV (Patent) Challenges for IBANDRONATE SODIUM

Tradename	Dosage	Ingredient	NDA	Submissiondate
BONIVA	INJECTABLE;INTRAVENOUS	ibandronate sodium	021858	2007-08-31
BONIVA	TABLET;ORAL	ibandronate sodium	021455	2007-05-16

US Patents and Regulatory Information for ibandronate sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma Ltd	IBANDRONATE SODIUM	ibandronate sodium	TABLET;ORAL	204502-001	Mar 11, 2016	AB	RX	No	No
Hoffmann La Roche	BONIVA	ibandronate sodium	TABLET;ORAL	021455-002	Mar 24, 2005	AB	RX	Yes	Yes
Nang Kuang Pharm Co	IBANDRONATE SODIUM	ibandronate sodium	INJECTABLE;INTRAVENOUS	204329-001	Jun 16, 2021	AP	RX	No	No

Expired US Patents for ibandronate sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hoffmann La Roche	BONIVA	ibandronate sodium	TABLET;ORAL	021455-001	May 16, 2003
Roche	BONIVA	ibandronate sodium	INJECTABLE;INTRAVENOUS	021858-001	Jan 6, 2006
Hoffmann La Roche	BONIVA	ibandronate sodium	TABLET;ORAL	021455-001	May 16, 2003

International Patents for ibandronate sodium

Country	Patent Number	Estimated Expiration
China	100551377
South Korea	20060058151
Japan	2005522526