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Last Updated: December 11, 2019

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 two 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. Thirteen 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 022560
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 0430-0979-03 4 TABLET, DELAYED RELEASE in 1 DOSE PACK (0430-0979-03)
ATELVIA risedronate sodium TABLET, DELAYED RELEASE;ORAL 022560 NDA Greenstone LLC 59762-0407 59762-0407-4 1 BLISTER PACK in 1 CARTON (59762-0407-4) > 4 TABLET, DELAYED RELEASE in 1 BLISTER PACK
Paragraph IV (Patent) Challenges for 022560
Tradename Dosage Ingredient NDA Submissiondate
ATELVIA TABLET, DELAYED RELEASE;ORAL risedronate sodium 022560 2011-06-09

Profile for product number 001

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

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