ALENDRONATE SODIUM - Generic Drug Details
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What are the generic drug sources for alendronate sodium and what is the scope of freedom to operate?
Alendronate sodium
is the generic ingredient in four branded drugs marketed by Hikma, Novitium Pharma, Merck, Radius, Apotex, Aurobindo Pharma, Chartwell Rx, Cipla, Hangzhou Binjiang, Impax Labs Inc, Ipca Labs Ltd, Jubilant Cadista, Mylan, Rising, Sun Pharm, Teva Pharms, Watson Labs, Organon, and Organon Llc, and is included in twenty NDAs. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Alendronate sodium has twenty patent family members in sixteen countries.
There are eighteen drug master file entries for alendronate sodium. Twenty-two suppliers are listed for this compound.
Summary for ALENDRONATE SODIUM
International Patents: | 20 |
US Patents: | 1 |
Tradenames: | 4 |
Applicants: | 19 |
NDAs: | 20 |
Drug Master File Entries: | 18 |
Finished Product Suppliers / Packagers: | 22 |
Raw Ingredient (Bulk) Api Vendors: | 57 |
Clinical Trials: | 39 |
Patent Applications: | 167 |
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 |
---|---|
National Heart, Lung, and Blood Institute (NHLBI) | Phase 2 |
Doris Duke Charitable Foundation | Phase 2 |
University of California, Davis | 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 | 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 ALENDRONATE SODIUM
Expired US Patents for ALENDRONATE SODIUM
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Organon | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-004 | Oct 20, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Merck | FOSAMAX | alendronate sodium | SOLUTION;ORAL | 021575-001 | Sep 17, 2003 | ⤷ Sign Up | ⤷ Sign Up |
Organon | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-004 | Oct 20, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Organon | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-004 | Oct 20, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Organon | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-002 | Sep 29, 1995 | ⤷ Sign Up | ⤷ Sign Up |
Organon | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-002 | Sep 29, 1995 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ALENDRONATE SODIUM
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 20140075638 | STABLE EFFERVESCENT BISPHOSPHONATE FORMULATIONS WITH RAPID SOLUBILIZATION CHARACTERISTICS | ⤷ Sign Up |
South Korea | 20180115254 | 신속한 용해 특성을 구비한 안정한 발포성 비스포스포네이트 제형 (STABLE EFFERVESCENT BISPHOSPHONATE FORMULATIONS WITH RAPID SOLUBILIZATION CHARACTERISTICS) | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2012078528 | ⤷ Sign Up | |
Spain | 2716525 | ⤷ Sign Up | |
South Korea | 102011505 | ⤷ Sign Up | |
European Patent Office | 2648702 | FORMULATIONS EFFERVESCENTES STABLES À BASE DE BISPHOSPHONATE PRÉSENTANT DES CARACTÉRISTIQUES DE SOLUBILISATION RAPIDE (STABLE EFFERVESCENT BISPHOSPHONATE FORMULATIONS WITH RAPID SOLUBILIZATION CHARACTERISTICS) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ALENDRONATE SODIUM
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1175904 | 2007C/048 | Belgium | ⤷ Sign Up | 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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