IBANDRONATE SODIUM - Generic Drug Details

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

Ibandronate sodium is the generic ingredient in two branded drugs marketed by Roche, Accord Hlthcare, Apotex, Avet Lifesciences, Eugia Pharma, Mylan Labs Ltd, Nang Kuang Pharm Co, Sagent Pharms Inc, Sun Pharm, Hoffmann La Roche, Apotex Inc, Aurobindo Pharma, Dr Reddys Labs Ltd, Macleods Pharms Ltd, Norvium Bioscience, Orbion Pharms, Sun Pharm Industries, and Watson Labs Teva, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for IBANDRONATE SODIUM

US Patents:	0
Tradenames:	2
Applicants:	18
NDAs:	18
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	237
Clinical Trials:	8
Patent Applications:	101
Drug Prices:	Drug price trends for IBANDRONATE SODIUM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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
National Cancer Institute (NCI)
Southwest Oncology Group
Dr. Reddy's Laboratories Limited	Phase 1

See all IBANDRONATE SODIUM clinical trials

Generic filers with tentative approvals for IBANDRONATE SODIUM

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	2.5MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	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	Strength	NDA	ANDAs Submitted	Submissiondate
BONIVA	Injection	ibandronate sodium	1 mg/mL, 3 mL Vial	021858	1	2007-08-31
BONIVA	Tablets	ibandronate sodium	2.5 mg	021455	1	2007-05-16

US Patents and Regulatory Information for IBANDRONATE 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
Sun Pharm	IBANDRONATE SODIUM	ibandronate sodium	INJECTABLE;INTRAVENOUS	090853-001	Feb 14, 2014		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Eugia Pharma	IBANDRONATE SODIUM	ibandronate sodium	INJECTABLE;INTRAVENOUS	205332-001	Aug 19, 2015	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Roche	BONIVA	ibandronate sodium	INJECTABLE;INTRAVENOUS	021858-001	Jan 6, 2006		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 IBANDRONATE SODIUM

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hoffmann La Roche	BONIVA	ibandronate sodium	TABLET;ORAL	021455-002	Mar 24, 2005	⤷ Sign Up	⤷ Sign Up
Roche	BONIVA	ibandronate sodium	INJECTABLE;INTRAVENOUS	021858-001	Jan 6, 2006	⤷ Sign Up	⤷ Sign Up
Hoffmann La Roche	BONIVA	ibandronate sodium	TABLET;ORAL	021455-001	May 16, 2003	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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