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Alendronate sodium - Generic Drug Details
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What are the generic sources for alendronate sodium and what is the scope of patent protection?
Alendronate sodium
is the generic ingredient in four branded drugs marketed by Hikma, Merck, Ascend Theraps Us, Apotex, Aurobindo Pharma, Cipla, Hangzhou Binjiang, Impax Labs Inc, Jubilant Cadista, Mylan, Neopharma, Sun Pharm, Teva Pharms, Upsher Smith Labs, Watson Labs, and Merck And Co Inc, and is included in eighteen NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Alendronate sodium has eleven patent family members in seven countries.
There are twenty-five drug master file entries for alendronate sodium. Twenty-one suppliers are listed for this compound.
Summary for alendronate sodium
International Patents: | 11 |
US Patents: | 2 |
Tradenames: | 4 |
Applicants: | 16 |
NDAs: | 18 |
Drug Master File Entries: | 25 |
Suppliers / Packagers: | 21 |
Bulk Api Vendors: | 41 |
Clinical Trials: | 27 |
Patent Applications: | 23 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for alendronate sodium |
Drug Sales Revenues: | Drug sales revenues for alendronate sodium |
What excipients (inactive ingredients) are in alendronate sodium? | alendronate sodium excipients list |
DailyMed Link: | alendronate sodium at DailyMed |
Recent Clinical Trials for alendronate sodium
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Peking Union Medical College Hospital | Phase 4 |
CSPC Ouyi Pharmaceutical Co., Ltd. | Phase 4 |
University of Baghdad | Phase 1/Phase 2 |
Pharmacology for alendronate sodium
Drug Class | Bisphosphonate |
Medical Subject Heading (MeSH) Categories for alendronate sodium
Paragraph IV (Patent) Challenges for ALENDRONATE SODIUM
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
FOSAMAX | SOLUTION;ORAL | alendronate sodium | 021575 | 2007-09-07 |
FOSAMAX | TABLET;ORAL | alendronate sodium | 020560 |
US Patents and Regulatory Information for alendronate sodium
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Neopharma | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 079049-001 | Aug 4, 2008 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Mylan | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 078638-001 | Aug 4, 2008 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Jubilant Cadista | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 090557-004 | Feb 18, 2010 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Aurobindo Pharma | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 090124-003 | Aug 4, 2008 | AB | RX | No | No | Start Trial | Start Trial | Start 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 alendronate sodium
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Merck And Co Inc | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-004 | Oct 20, 2000 | Start Trial | Start Trial |
Merck And Co Inc | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-002 | Sep 29, 1995 | Start Trial | Start Trial |
Merck And Co Inc | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-001 | Sep 29, 1995 | Start Trial | Start Trial |
Merck And Co Inc | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-001 | Sep 29, 1995 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for alendronate sodium
Country | Patent Number | Estimated Expiration |
---|---|---|
Canada | 2495886 | Start Trial |
Denmark | 1490024 | Start Trial |
Spain | 2448501 | Start Trial |
European Patent Office | 1490024 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for alendronate sodium
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1175904 | 2007C/048 | Belgium | Start Trial | PRODUCT NAME: ALENDRONATE DE SODIUM/COLECALCIFEROL; AUTHORISATION NUMBER AND DATE: EU/1/05/310/001 20050826 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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