.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022560

« Back to Dashboard
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. Eleven suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the risedronate sodium profile page.

Summary for NDA: 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

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 Warner Chilcott (US), LLC 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 Actavis Pharma, Inc. 0591-3876 0591-3876-04 4 TABLET, DELAYED RELEASE in 1 DOSE PACK (0591-3876-04)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength35MG
Approval Date:Oct 8, 2010TE:ABRLD:Yes
Patent:8,246,989Patent Expiration:Jan 16, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:7,645,459Patent Expiration:Jan 9, 2028Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
Patent:7,645,460Patent Expiration:Jan 9, 2028Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN

Expired Orange Book Patents for NDA: 022560

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil
ATELVIA
risedronate sodium
TABLET, DELAYED RELEASE;ORAL022560-001Oct 8, 20105,583,122*PED► subscribe
Apil
ATELVIA
risedronate sodium
TABLET, DELAYED RELEASE;ORAL022560-001Oct 8, 20105,622,721► subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.



Complete Access Available with Subscription
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

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.

`abc