Serving 500+ biopharmaceutical companies globally:
Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing
Serving 500+ biopharmaceutical companies globally:
Generated: August 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.| Tradenames: | 4 |
| Patents: | 5 |
| Applicants: | 16 |
| NDAs: | 18 |
| Drug Master File Entries: see list | 25 |
| Suppliers / Packagers: see list | 30 |
| Bulk Api Vendors: see list | 127 |
| Clinical Trials: see list | 2,493 |
| Patent Applications: see list | 7,614 |
| 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 |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sun Pharma Global | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 090022-003 | Sep 10, 2008 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Dr Reddys Labs Ltd | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 079049-004 | Aug 4, 2008 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
West-ward Pharms Int | ALENDRONATE SODIUM | alendronate sodium | SOLUTION;ORAL | 090520-001 | Feb 25, 2013 | RX | No | Yes | ► Subscribe | ► Subscribe | ► Subscribe | ||||||||||||||||||
Jubilant Cadista | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 090557-001 | Feb 18, 2010 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
Apotex | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 077982-002 | Aug 4, 2008 | AB | RX | No | No | ► Subscribe | ► Subscribe | ► Subscribe | |||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
Export unavailable in trial.
Subscribe for complete access.
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Merck And Co Inc | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-002 | Sep 29, 1995 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Merck And Co Inc | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-003 | Apr 25, 1997 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Merck And Co Inc | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-005 | Oct 20, 2000 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Merck And Co Inc | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-005 | Oct 20, 2000 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
Merck And Co Inc | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-002 | Sep 29, 1995 | ► Subscribe | ► Subscribe | ||||||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
Export unavailable in trial.
Subscribe for complete access.
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 6,544,967 | 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 | |||||||||||||||||||||||||||
| 6,465,443 | Method for inhibiting bone resorption | ► Subscribe | |||||||||||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
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.
Export unavailable in trial.
Subscribe for complete access.
| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Australia | 741818 | ► Subscribe | |||||||||||||||||||||||||||
| Portugal | 1175904 | ► Subscribe | |||||||||||||||||||||||||||
| Chile | 2004000690 | ► Subscribe | |||||||||||||||||||||||||||
| Netherlands | 300223 | ► Subscribe | |||||||||||||||||||||||||||
| South Korea | 20030097610 | ► Subscribe | |||||||||||||||||||||||||||
| This preview shows a limited data set Subscribe for full access, or try a Trial | |||||||||||||||||||||||||||||
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.
Export unavailable in trial.
Subscribe for complete access.
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | ||||||||||||||||||||||||||
| 2007 00045 | Denmark | ► Subscribe | |||||||||||||||||||||||||||
| 2006 00005 | Denmark | ► Subscribe | |||||||||||||||||||||||||||
| 222 | Luxembourg | ► Subscribe | 91222, EXPIRES: 20200824 | ||||||||||||||||||||||||||
| 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 | |||||||||||||||||||||||||||||
Export unavailable in trial.
Subscribe for complete access.
Serving 500+ 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.
Follow DrugPatentWatch:
Join the 22,321 others who get our Drug Patent Expiration Alerts:
