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Generated: April 24, 2019

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FOSAMAX PLUS D Drug Profile

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When do Fosamax Plus D patents expire, and what generic alternatives are available?

Fosamax Plus D is a drug marketed by Merck and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has ninety-one patent family members in forty countries.

The generic ingredient in FOSAMAX PLUS D is alendronate sodium; cholecalciferol. There are twenty-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the alendronate sodium; cholecalciferol profile page.

US Patents and Regulatory Information for FOSAMAX PLUS D

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-001 Apr 7, 2005 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Merck FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-002 Apr 26, 2007 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ 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 FOSAMAX PLUS D

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Merck FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-002 Apr 26, 2007 ➤ Sign Up ➤ Sign Up
Merck FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-002 Apr 26, 2007 ➤ Sign Up ➤ Sign Up
Merck FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-001 Apr 7, 2005 ➤ Sign Up ➤ Sign Up
Merck FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-001 Apr 7, 2005 ➤ Sign Up ➤ Sign Up
Merck FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-001 Apr 7, 2005 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for FOSAMAX PLUS D
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 70 mg/2800 IU and 70 mg/5600 IU ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for FOSAMAX PLUS D

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1175904 2007C/048 Belgium ➤ Sign Up PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826
1175904 C01175904/01 Switzerland ➤ Sign Up FORMER OWNER: SCHERING CORPORATION, US
1175904 C300292 Netherlands ➤ Sign Up 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
0998292 CA 2006 00005 Denmark ➤ Sign Up PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, COLECALCIFEROL
1175904 PA2007007 Lithuania ➤ Sign Up 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
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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