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
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 | ||||
>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 | 020560-005 | Oct 20, 2000 | ⤷ 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 |
>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 |
---|---|---|---|
New Zealand | 289231 | PHARMACEUTICAL COMPOSITIONS COMPRISING ALENDRONATE, BUFFER AND A COMPLEXING AGENT | ⤷ Try a Trial |
Slovakia | 111697 | USING ALENDRONATE FOR LESSENING THE RISK OF VERTEBRAL FRACTURES | ⤷ Try a Trial |
Finland | 964593 | ⤷ 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 |
---|---|---|---|---|
0998292 | CA 2006 00005 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, COLECALCIFEROL |
1175904 | CA 2007 00045 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, OG COLECALCIFEROL |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |