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Last Updated: March 28, 2024

FOSAMAX Drug Patent Profile


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Drug patent expirations by year for FOSAMAX
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Drug Sales Revenue Trends for FOSAMAX

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Recent Clinical Trials for FOSAMAX

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SponsorPhase
Aristotle University Of ThessalonikiPhase 4
424 General Military HospitalPhase 4
Yonsei UniversityPhase 4

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Pharmacology for FOSAMAX
Drug ClassBisphosphonate
Paragraph IV (Patent) Challenges for FOSAMAX
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
FOSAMAX Oral Solution alendronate sodium 70 mg/75 mL 021575 1 2007-09-07

US Patents and Regulatory Information for FOSAMAX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck FOSAMAX alendronate sodium SOLUTION;ORAL 021575-001 Sep 17, 2003 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Organon Llc FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-001 Apr 7, 2005 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Organon FOSAMAX alendronate sodium TABLET;ORAL 020560-004 Oct 20, 2000 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Organon Llc FOSAMAX PLUS D alendronate sodium; cholecalciferol TABLET;ORAL 021762-002 Apr 26, 2007 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Organon FOSAMAX alendronate sodium TABLET;ORAL 020560-003 Apr 25, 1997 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for FOSAMAX

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Organon FOSAMAX alendronate sodium TABLET;ORAL 020560-001 Sep 29, 1995 ⤷  Try a Trial ⤷  Try a Trial
Organon FOSAMAX alendronate sodium TABLET;ORAL 020560-001 Sep 29, 1995 ⤷  Try a Trial ⤷  Try a Trial
Organon FOSAMAX alendronate sodium TABLET;ORAL 020560-005 Oct 20, 2000 ⤷  Try a Trial ⤷  Try a Trial
Organon FOSAMAX alendronate sodium TABLET;ORAL 020560-002 Sep 29, 1995 ⤷  Try a Trial ⤷  Try a Trial
Organon FOSAMAX alendronate sodium TABLET;ORAL 020560-004 Oct 20, 2000 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for FOSAMAX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1175904 CA 2007 00045 Denmark ⤷  Try a Trial PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, OG COLECALCIFEROL
0998292 91222 Luxembourg ⤷  Try a Trial 91222, EXPIRES: 20200824
0998292 PA2006002 Lithuania ⤷  Try a 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
1175904 PA2007007 Lithuania ⤷  Try a 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
1175904 C01175904/01 Switzerland ⤷  Try a Trial FORMER OWNER: SCHERING CORPORATION, US
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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