ALENDRONATE SODIUM - Generic Drug Details
✉ Email this page to a colleague
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 |
---|---|
University of California, Davis | Phase 2 |
National Heart, Lung, and Blood Institute (NHLBI) | Phase 2 |
Doris Duke Charitable Foundation | 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Aurobindo Pharma | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 090124-003 | Aug 4, 2008 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Rising | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 076584-002 | Aug 4, 2008 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Ipca Labs Ltd | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 206387-004 | Jun 4, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Rising | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 076584-003 | Aug 4, 2008 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Hangzhou Binjiang | ALENDRONATE SODIUM | alendronate sodium | TABLET;ORAL | 090258-004 | Sep 24, 2009 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>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 | 020560-005 | 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 | 020560-005 | Oct 20, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Organon | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-003 | Apr 25, 1997 | ⤷ Sign Up | ⤷ Sign Up |
Organon | FOSAMAX | alendronate sodium | TABLET;ORAL | 020560-003 | Apr 25, 1997 | ⤷ 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 |
---|---|---|---|
Spain | 2716525 | ⤷ Sign Up | |
Malaysia | 166971 | STABLE EFFERVESCENT BISPHOSPHONATE FORMULATIONS WITH RAPID SOLUBILIZATION CHARACTERISTICS | ⤷ Sign Up |
Poland | 2648702 | ⤷ Sign Up | |
South Korea | 20180115254 | 신속한 용해 특성을 구비한 안정한 발포성 비스포스포네이트 제형 (STABLE EFFERVESCENT BISPHOSPHONATE FORMULATIONS WITH RAPID SOLUBILIZATION CHARACTERISTICS) | ⤷ Sign Up |
South Korea | 102011505 | ⤷ 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 |
Make Better Decisions: Try a trial or see plans & pricing
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 verification 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.