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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
Cipla
Daiichi Sankyo
McKinsey
Mallinckrodt
UBS
Cerilliant
Queensland Health
US Army

Generated: April 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022560

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NDA 022560 describes ATELVIA, which is a drug marketed by Apil and is included in one NDA. It is available from three suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ATELVIA profile page.

The generic ingredient in ATELVIA is risedronate sodium. There are nineteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the risedronate sodium profile page.
Summary for 022560
Tradename:ATELVIA
Applicant:Apil
Ingredient:risedronate sodium
Patents:3
Therapeutic Class:Metabolic Bone Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 022560
Ingredient-typeDiphosphonates
Medical Subject Heading (MeSH) Categories for 022560
Suppliers and Packaging for NDA: 022560
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ATELVIA risedronate sodium TABLET, DELAYED RELEASE;ORAL 022560 NDA Allergan, Inc. 0430-0979 N 0430-0979-03
ATELVIA risedronate sodium TABLET, DELAYED RELEASE;ORAL 022560 NDA Actavis Pharma, Inc. 0591-3876 N 0591-3876-04

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength35MG
Approval Date:Oct 8, 2010TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jan 9, 2028Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
Patent:➤ Try a Free TrialPatent Expiration:Jan 9, 2028Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
Patent:➤ Try a Free TrialPatent Expiration:Jan 16, 2026Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 022560

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil ATELVIA risedronate sodium TABLET, DELAYED RELEASE;ORAL 022560-001 Oct 8, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Apil ATELVIA risedronate sodium TABLET, DELAYED RELEASE;ORAL 022560-001 Oct 8, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
US Army
Merck
Federal Trade Commission
Farmers Insurance
QuintilesIMS
Accenture
Teva
Julphar

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