Fosamax Drug Patent Profile
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When do Fosamax patents expire, and when can generic versions of Fosamax launch?
Fosamax is a drug marketed by Merck, Organon, and Organon Llc. and is included in three NDAs.
The generic ingredient in FOSAMAX 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.
Summary for Fosamax
US Patents: | 0 |
Applicants: | 3 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 171 |
Clinical Trials: | 62 |
Patent Applications: | 3,619 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for Fosamax |
Drug Sales Revenues: | Drug sales revenues for Fosamax |
What excipients (inactive ingredients) are in Fosamax? | Fosamax excipients list |
DailyMed Link: | Fosamax at DailyMed |
Recent Clinical Trials for Fosamax
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Aristotle University Of Thessaloniki | Phase 4 |
424 General Military Hospital | Phase 4 |
Yonsei University | Phase 4 |
Pharmacology for Fosamax
Drug Class | Bisphosphonate |
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
Expired US Patents for Fosamax
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Organon | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-003 | Apr 25, 1997 | ⤷ Try a Trial | ⤷ Try a Trial |
Merck | FOSAMAX | alendronate sodium | SOLUTION;ORAL | 021575-001 | Sep 17, 2003 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-004 | 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 | 020560-002 | 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 |
Organon | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-001 | Sep 29, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for Fosamax
See the table below for patents covering Fosamax around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Algeria | 1991 | Procédé pour diminuer le risque de fractures vertébrales et non vertébrales. | ⤷ Try a Trial |
New Zealand | 303022 | Treatment of osteoporotic diseases with alendronate | ⤷ Try a Trial |
European Patent Office | 0998292 | PROCEDE D'INHIBITION DE RESORPTION OSSEUSE (METHOD FOR INHIBITING BONE RESORPTION) | ⤷ Try a Trial |
Spain | 2150979 | ⤷ Try a Trial | |
United Kingdom | 9717850 | ⤷ Try a Trial | |
China | 1079672 | ⤷ Try a Trial | |
Luxembourg | 91364 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for Fosamax
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1175904 | C01175904/01 | Switzerland | ⤷ Try a Trial | FORMER OWNER: SCHERING CORPORATION, US |
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 |
0998292 | CA 2006 00005 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, COLECALCIFEROL |
0998292 | 91222 | Luxembourg | ⤷ Try a Trial | 91222, EXPIRES: 20200824 |
1175904 | 2007C/048 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826 |
1175904 | 91364 | Luxembourg | ⤷ Try a Trial | 91364, EXPIRES: 20200826 |
1175904 | CA 2007 00045 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, OG COLECALCIFEROL |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |