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Generated: October 17, 2017
What are the generic sources for alendronate sodium and what is the scope of alendronate sodium freedom to operate?
Alendronate sodium is the generic ingredient in four branded drugs marketed by Impax Labs Inc, West-ward Pharms Int, Sun Pharma Global, Aurobindo Pharma, Mylan, Mission Pharma, Dr Reddys Labs Ltd, Jubilant Cadista, Austarpharma Llc, Merck And Co Inc, Cipla Ltd, Upsher-smith Labs, Merck, Apotex, Teva Pharms, and Watson Labs, and is included in eighteen NDAs. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.| US Patents: | 5 |
| Tradenames: | 4 |
| Applicants: | 16 |
| NDAs: | 18 |
| Drug Master File Entries: see list | 25 |
| Suppliers / Packagers: see list | 31 |
| Bulk Api Vendors: see list | 127 |
| Clinical Trials: see list | 2,515 |
| Patent Applications: see list | 7,568 |
| Therapeutic Class: | Metabolic Bone Disease Agents |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see low prices |
| DailyMed Link: | alendronate sodium at DailyMed |
| Ingredient-type | Diphosphonates |
| Drug Class | Bisphosphonate |
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For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.
The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.
| Patent No. | Title | Estimated Patent Expiration | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,465,443 | Method for inhibiting bone resorption | ► Subscribe | |||||||||||||
| 8,449,906 | Effervescent compositions comprising phosphonates and methods related thereto | ► Subscribe | |||||||||||||
| 6,333,316 | Method for inhibiting bone resorption | ► Subscribe | |||||||||||||
| 6,432,932 | Method for inhibiting bone resorption | ► Subscribe | |||||||||||||
| 6,544,967 | Method for inhibiting bone resorption | ► Subscribe | |||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.
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| Country | Document Number | Estimated Expiration | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Australia | 741818 | ► Subscribe | |||||||||||||
| Denmark | 0998292 | ► Subscribe | |||||||||||||
| Canada | 2349744 | ► Subscribe | |||||||||||||
| United Kingdom | 9717590 | ► Subscribe | |||||||||||||
| New Zealand | 501807 | ► Subscribe | |||||||||||||
| Japan | 3479780 | ► Subscribe | |||||||||||||
| Iceland | 7231 | ► Subscribe | |||||||||||||
| Bulgaria | 66282 | ► Subscribe | |||||||||||||
| Yugoslavia | 1800 | ► Subscribe | |||||||||||||
| Serbia | 49979 | ► Subscribe | |||||||||||||
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws,
it is advisable to have patent counsel verify freedom to operate.
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| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 222 | Luxembourg | ► Subscribe | 91222, EXPIRES: 20200824 | ||||||||||||
| 2006002 | Lithuania | ► Subscribe | 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 | ||||||||||||
| 364 | Luxembourg | ► Subscribe | 91364, EXPIRES: 20200826 | ||||||||||||
| 2007 00045 | Denmark | ► Subscribe | |||||||||||||
| 1175904/01 | Switzerland | ► Subscribe | FORMER OWNER: SCHERING CORPORATION, US | ||||||||||||
| 2006 00005 | Denmark | ► Subscribe | |||||||||||||
| 2007007 | Lithuania | ► Subscribe | 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 | ||||||||||||
| 00292 | Netherlands | ► Subscribe | 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 | ||||||||||||
| 2006002,C0998292 | Lithuania | ► Subscribe | 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 | ||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||
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Serving leading biopharmaceutical companies globally:
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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