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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Mallinckrodt
Johnson and Johnson
US Army
Medtronic
Citi
Dow
Teva
Merck

Generated: November 20, 2018

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FOSAMAX PLUS D Drug Profile

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When do Fosamax Plus D patents expire, and when can generic versions of Fosamax Plus D launch?

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.

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.

Drug patent expirations by year for FOSAMAX PLUS D
Generic Entry Opportunity Date for FOSAMAX PLUS D
Generic Entry Date for FOSAMAX PLUS D*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
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.

Pharmacology for FOSAMAX PLUS D

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 Y ➤ 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 021762-001 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 021762-002 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 021762-002 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
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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2007007 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
222 Luxembourg ➤ Sign Up 91222, EXPIRES: 20200824
1175904/01 Switzerland ➤ Sign Up FORMER OWNER: SCHERING CORPORATION, US
2007 00045 Denmark ➤ Sign Up PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, OG COLECALCIFEROL
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
00292 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Mallinckrodt
Johnson and Johnson
US Army
Medtronic
Citi
Dow
Teva
Merck

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