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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Moodys
AstraZeneca
Johnson and Johnson
Federal Trade Commission
Citi
QuintilesIMS
Mallinckrodt
Chubb
Accenture

Generated: February 20, 2018

DrugPatentWatch Database Preview

ACTONEL Drug Profile

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When do Actonel patents expire, and what generic alternatives are available?

Actonel is a drug marketed by Apil and Warner Chilcott and is included in two NDAs. There are seven patents protecting this drug and four Paragraph IV challenges.

This drug has one hundred and ninety-eight patent family members in forty-nine countries.

The generic ingredient in ACTONEL is calcium carbonate; risedronate sodium. There are two hundred and seventy-two drug master file entries for this compound. Additional details are available on the calcium carbonate; risedronate sodium profile page.
Drug patent expirations by year for ACTONEL
Pharmacology for ACTONEL
Ingredient-typeDiphosphonates
Drug ClassBisphosphonate

US Patents and Regulatory Information for ACTONEL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-002 Apr 14, 2000 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Warner Chilcott ACTONEL WITH CALCIUM (COPACKAGED) calcium carbonate; risedronate sodium TABLET, TABLET;ORAL 021823-001 Aug 12, 2005 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-004 Apr 16, 2007 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Warner Chilcott ACTONEL WITH CALCIUM (COPACKAGED) calcium carbonate; risedronate sodium TABLET, TABLET;ORAL 021823-001 Aug 12, 2005 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Warner Chilcott ACTONEL WITH CALCIUM (COPACKAGED) calcium carbonate; risedronate sodium TABLET, TABLET;ORAL 021823-001 Aug 12, 2005 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-001 Mar 27, 1998 AB RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for ACTONEL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-002 Apr 14, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-001 Mar 27, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-003 May 25, 2002 ➤ Try a Free Trial ➤ Try a Free Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-004 Apr 16, 2007 ➤ Try a Free Trial ➤ Try a Free Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-002 Apr 14, 2000 ➤ Try a Free Trial ➤ Try a Free Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-004 Apr 16, 2007 ➤ Try a Free Trial ➤ Try a Free Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-005 Apr 22, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Apil ACTONEL risedronate sodium TABLET;ORAL 020835-001 Mar 27, 1998 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for ACTONEL
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 150 mg ➤ Subscribe 8/12/2008
➤ Subscribe Tablets 35 mg; 500 mg ➤ Subscribe 12/18/2007
➤ Subscribe Tablets 75 mg ➤ Subscribe 9/10/2007
➤ Subscribe Tablets 5 mg, 30 mg and 35 mg ➤ Subscribe 4/23/2004

Non-Orange Book US Patents for ACTONEL

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,410,957 Method of treatment using bisphosphonic acid ➤ Try a Free Trial
6,225,294 Method for inhibiting bone resorption ➤ Try a Free Trial
6,569,460 Film-coated tablet for improved upper gastrointestinal tract safety ➤ Try a Free Trial
6,333,316 Method for inhibiting bone resorption ➤ Try a Free Trial
6,544,967 Method for inhibiting bone resorption ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for ACTONEL

Supplementary Protection Certificates for ACTONEL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
364 Luxembourg ➤ Try a Free Trial 91364, EXPIRES: 20200826
2007 00045 Denmark ➤ Try a Free Trial PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, OG COLECALCIFEROL
2007007 Lithuania ➤ Try a Free Trial PRODUCT NAME: ACIDUM ALENDRONICUM NATRIUM, COLECALCIFEROLUM; REGISTRATION NO/DATE: EU/1/05/310/001 2005 08 24 EU/1/05/310/002 2005 08 24 EU/1/05/310/003 2005 08 24 EU/1/05/310/004 2005 08 24 EU/1/05/310/00 20050824
2006002 Lithuania ➤ Try a Free Trial PRODUCT NAME: NATRIUM ALENDRONICUM/COLECACIFEROLUM; REGISTRATION NO/DATE: EU/1/05/310/001, EU/1/05/310/002, EU/1/05/310/003, EU/1/05/310/004, EU/1/05/310/005 20050824
00292 Netherlands ➤ Try a Free Trial PRODUCT NAME: ALENDRONINE ZUUR, BIJ VOORKEUR MET MONONATRIUMZOUT IN HET BIJZONDER HET MONONATRIUM TRIHYDRAATZOUT, EN COLECALCIFEROL, WAARIN 70MG ALENDRONINEZUUR AANWEZIG IS, GEBASSERD OP HET GEWICHT VAN ALENDRONINE; REGISTRATION NO/DATE: EU/1/05/310/001-005 20050824
2006002,C0998292 Lithuania ➤ Try a Free Trial PRODUCT NAME: NATRIUM ALENDRONICUM/COLECACIFEROLUM; REGISTRATION NO/DATE: EU/1/05/310/001, EU/1/05/310/002, EU/1/05/310/003, EU/1/05/310/004, EU/1/05/310/005 20050824
2006 00005 Denmark ➤ Try a Free Trial PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, COLECALCIFEROL
222 Luxembourg ➤ Try a Free Trial 91222, EXPIRES: 20200824
1175904/01 Switzerland ➤ Try a Free Trial FORMER OWNER: SCHERING CORPORATION, US
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Queensland Health
Cerilliant
Healthtrust
Johnson and Johnson
Federal Trade Commission
Farmers Insurance
McKinsey
Cantor Fitzgerald

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