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Generated: October 21, 2018

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ACTONEL WITH CALCIUM (COPACKAGED) Drug Profile

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When do Actonel With Calcium (copackaged) patents expire, and what generic alternatives are available?

Actonel With Calcium (copackaged) is a drug marketed by Warner Chilcott and is included in one NDA. There are five patents protecting this drug.

The generic ingredient in ACTONEL WITH CALCIUM (COPACKAGED) 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.

Drug patent expirations by year for ACTONEL WITH CALCIUM (COPACKAGED)
Generic Entry Opportunity Date for ACTONEL WITH CALCIUM (COPACKAGED)
Generic Entry Date for ACTONEL WITH CALCIUM (COPACKAGED)*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for ACTONEL WITH CALCIUM (COPACKAGED)

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Warner Chilcott ACTONEL WITH CALCIUM (COPACKAGED) calcium carbonate; risedronate sodium TABLET, TABLET;ORAL 021823-001 Aug 12, 2005 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Warner Chilcott ACTONEL WITH CALCIUM (COPACKAGED) calcium carbonate; risedronate sodium TABLET, TABLET;ORAL 021823-001 Aug 12, 2005 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Warner Chilcott ACTONEL WITH CALCIUM (COPACKAGED) calcium carbonate; risedronate sodium TABLET, TABLET;ORAL 021823-001 Aug 12, 2005 DISCN Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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 WITH CALCIUM (COPACKAGED)

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Warner Chilcott ACTONEL WITH CALCIUM (COPACKAGED) calcium carbonate; risedronate sodium TABLET, TABLET;ORAL 021823-001 Aug 12, 2005 ➤ Sign Up ➤ Sign Up
Warner Chilcott ACTONEL WITH CALCIUM (COPACKAGED) calcium carbonate; risedronate sodium TABLET, TABLET;ORAL 021823-001 Aug 12, 2005 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for ACTONEL WITH CALCIUM (COPACKAGED)

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2006002 Lithuania ➤ Sign Up 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 ➤ Sign Up PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, COLECALCIFEROL
/2008 Austria ➤ Sign Up PRODUCT NAME: FOSAMPRENAVIR ALS FOSAMPRENAVIR-CALCIUM; REGISTRATION NO/DATE: EU/1/04/282/001 - EU/1/04/282/002 (MITTEILUNG VOM 14.07.2004) 20040713
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
McKesson
Cipla
Farmers Insurance
Daiichi Sankyo
Federal Trade Commission
Harvard Business School
UBS
McKinsey

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