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, Jubilant Cadista, Mylan, Rising, Sun Pharm, Teva Pharms, Watson Labs, Organon, and Organon Llc, and is included in nineteen 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 suppliers are listed for this compound.
Summary for ALENDRONATE SODIUM
International Patents: | 20 |
US Patents: | 1 |
Tradenames: | 4 |
Applicants: | 18 |
NDAs: | 19 |
Drug Master File Entries: | 18 |
Finished Product Suppliers / Packagers: | 20 |
Raw Ingredient (Bulk) Api Vendors: | 57 |
Clinical Trials: | 38 |
Patent Applications: | 193 |
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 |
---|---|
Aristotle University Of Thessaloniki | Phase 4 |
424 General Military Hospital | Phase 4 |
Shanghai JMT-Bio Inc. | 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
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Impax Labs Inc | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 075710-001 | Feb 6, 2008 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Chartwell Rx | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 079049-002 | Aug 4, 2008 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Aurobindo Pharma | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 090124-002 | Aug 4, 2008 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 |
---|---|---|---|---|---|---|---|
Organon | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-002 | Sep 29, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-005 | Oct 20, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
Organon | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-002 | Sep 29, 1995 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ALENDRONATE SODIUM
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Russian Federation | 2013109765 | СТАБИЛЬНЫЕ СОСТАВЫ ШИПУЧЕГО БИСФОСФОНАТА СО СВОЙСТВАМИ БЫСТРОЙ СОЛЮБИЛИЗАЦИИ | ⤷ Try a Trial |
South Korea | 20140075638 | STABLE EFFERVESCENT BISPHOSPHONATE FORMULATIONS WITH RAPID SOLUBILIZATION CHARACTERISTICS | ⤷ Try a Trial |
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) | ⤷ Try a Trial |
>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 | ⤷ Try a 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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