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Generated: November 14, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020835

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NDA 020835 describes ACTONEL, which is a drug marketed by Apil and Warner Chilcott and is included in two NDAs. It is available from four suppliers. There are seven patents protecting this drug and four Paragraph IV challenges. Additional details are available on the ACTONEL profile page.

The generic ingredient in ACTONEL is calcium carbonate; risedronate sodium. There are two hundred and seventy-eight drug master file entries for this compound. Additional details are available on the calcium carbonate; risedronate sodium profile page.
Summary for 020835
Tradename:ACTONEL
Applicant:Apil
Ingredient:risedronate sodium
Patents:7
Formulation / Manufacturing:see details
Pharmacology for NDA: 020835
Ingredient-typeDiphosphonates
Medical Subject Heading (MeSH) Categories for 020835
Suppliers and Packaging for NDA: 020835
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACTONEL risedronate sodium TABLET;ORAL 020835 NDA Warner Chilcott Pharmaceuticals Inc. 0149-0470 0149-0470-01 12 BOTTLE in 1 CASE (0149-0470-01) > 30 TABLET, FILM COATED in 1 BOTTLE
ACTONEL risedronate sodium TABLET;ORAL 020835 NDA Warner Chilcott Pharmaceuticals Inc. 0149-0471 0149-0471-01 12 BOTTLE in 1 CASE (0149-0471-01) > 30 TABLET, FILM COATED in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength30MG
Approval Date:Mar 27, 1998TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Dec 10, 2018Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Apr 14, 2000TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Dec 10, 2018Product Flag?Substance Flag?Delist Request?Y

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength35MG
Approval Date:May 25, 2002TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Jan 17, 2019Product Flag?Substance Flag?Delist Request?Y

Expired US Patents for NDA 020835

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-001 Mar 27, 1998 ➤ Sign Up ➤ Sign Up
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-004 Apr 16, 2007 ➤ Sign Up ➤ Sign Up
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-002 Apr 14, 2000 ➤ Sign Up ➤ Sign Up
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-002 Apr 14, 2000 ➤ Sign Up ➤ Sign Up
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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