FOSAMAX PLUS D Drug Patent 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 Organon Llc and is included in one NDA.
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.
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Summary for FOSAMAX PLUS D
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 4 |
Clinical Trials: | 63 |
Drug Prices: | Drug price information for FOSAMAX PLUS D |
What excipients (inactive ingredients) are in FOSAMAX PLUS D? | FOSAMAX PLUS D excipients list |
DailyMed Link: | FOSAMAX PLUS D at DailyMed |
Recent Clinical Trials for FOSAMAX PLUS D
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Heart, Lung, and Blood Institute (NHLBI) | Phase 2 |
Doris Duke Charitable Foundation | Phase 2 |
University of California, Davis | Phase 2 |
Pharmacology for FOSAMAX PLUS D
Drug Class | Bisphosphonate Vitamin D |
Paragraph IV (Patent) Challenges for FOSAMAX PLUS D
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
FOSAMAX PLUS D | Tablets | alendronate sodium; cholecalciferol | 70 mg/2800 IU and 70 mg/5600 IU | 021762 | 1 | 2007-11-20 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Organon Llc | FOSAMAX PLUS D | alendronate sodium; cholecalciferol | TABLET;ORAL | 021762-001 | Apr 7, 2005 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Organon Llc | 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 |
Expired US Patents for FOSAMAX PLUS D
International Patents for FOSAMAX PLUS D
See the table below for patents covering FOSAMAX PLUS D around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Slovakia | 282100 | ⤷ Sign Up | |
Portugal | 1175904 | ⤷ Sign Up | |
Yugoslavia | 1800 | ⤷ Sign Up | |
South Africa | 9308979 | ⤷ Sign Up | |
Norway | 952184 | ⤷ Sign Up | |
Australia | 6406900 | ⤷ Sign Up | |
Hong Kong | 1024166 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for FOSAMAX PLUS D
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0998292 | PA2006002,C0998292 | 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 |
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 |
1175904 | CA 2007 00045 | Denmark | ⤷ Sign Up | PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, OG COLECALCIFEROL |
0998292 | PA2006002 | 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 |
1175904 | 2007C/048 | Belgium | ⤷ Sign Up | PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826 |
0998292 | 91222 | Luxembourg | ⤷ Sign Up | 91222, EXPIRES: 20200824 |
0998292 | CA 2006 00005 | Denmark | ⤷ Sign Up | PRODUCT NAME: ALENDRONSYRE, NATRIUMTRIHYDRAT, COLECALCIFEROL |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |