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Etidronate disodium - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for etidronate disodium?

Etidronate disodium is the generic ingredient in two branded drugs marketed by Mylan, Apil, and Mgi Pharma Inc, and is included in three NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for etidronate disodium. Two suppliers are listed for this compound.

Summary for Generic Name: etidronate disodium

Tradenames:2
Patents:1
Applicants:3
NDAs:3
Drug Master File Entries: see list4
Suppliers / Packagers: see list2
Bulk Api Vendors: see list25
Clinical Trials: see list53
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:etidronate disodium at DailyMed

Pharmacology for Ingredient: etidronate disodium

Ingredient-typeDiphosphonates
Drug ClassBisphosphonate
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan
ETIDRONATE DISODIUM
etidronate disodium
TABLET;ORAL075800-002Jan 24, 2003RXNoNo► Subscribe► Subscribe
Mgi Pharma Inc
DIDRONEL
etidronate disodium
INJECTABLE;INJECTION019545-001Apr 20, 1987DISCNNoNo► Subscribe► Subscribe
Mylan
ETIDRONATE DISODIUM
etidronate disodium
TABLET;ORAL075800-001Jan 24, 2003RXNoNo► Subscribe► Subscribe
Apil
DIDRONEL
etidronate disodium
TABLET;ORAL017831-001Approved Prior to Jan 1, 1982RXYesNo► Subscribe► Subscribe
Apil
DIDRONEL
etidronate disodium
TABLET;ORAL017831-002Approved Prior to Jan 1, 1982RXYesYes► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: etidronate disodium

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mgi Pharma Inc
DIDRONEL
etidronate disodium
INJECTABLE;INJECTION019545-001Apr 20, 19874,216,211► Subscribe
Apil
DIDRONEL
etidronate disodium
TABLET;ORAL017831-001Approved Prior to Jan 1, 19823,683,080► Subscribe
Mgi Pharma Inc
DIDRONEL
etidronate disodium
INJECTABLE;INJECTION019545-001Apr 20, 19873,683,080► Subscribe
Mgi Pharma Inc
DIDRONEL
etidronate disodium
INJECTABLE;INJECTION019545-001Apr 20, 19874,254,114► Subscribe
Apil
DIDRONEL
etidronate disodium
TABLET;ORAL017831-002Approved Prior to Jan 1, 19823,683,080► 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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