You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: April 20, 2024

Alendronate sodium - Generic Drug Details

✉ Email this page to a colleague

« Back to Dashboard

What are the generic sources for alendronate sodium and what is the scope of patent protection?

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

See drug prices for alendronate sodium

Drug Sales Revenue Trends for alendronate sodium

See drug sales revenues for alendronate sodium

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

See all alendronate sodium clinical trials

Pharmacology for alendronate sodium

Drug Class	Bisphosphonate

Medical Subject Heading (MeSH) Categories for alendronate sodium

Bone Density Conservation Agents

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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or 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
Impax Labs Inc	ALENDRONATE SODIUM	alendronate sodium	TABLET;ORAL	075710-004	Feb 6, 2008		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Cipla	ALENDRONATE SODIUM	alendronate sodium	TABLET;ORAL	076768-005	Aug 4, 2008	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan	ALENDRONATE SODIUM	alendronate sodium	TABLET;ORAL	078638-001	Aug 4, 2008		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Chartwell Rx	ALENDRONATE SODIUM	alendronate sodium	TABLET;ORAL	079049-004	Aug 4, 2008		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Watson Labs	ALENDRONATE SODIUM	alendronate sodium	TABLET;ORAL	076984-003	Aug 4, 2008	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Rising	ALENDRONATE SODIUM	alendronate sodium	TABLET;ORAL	076584-004	Aug 4, 2008		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Chartwell Rx	ALENDRONATE SODIUM	alendronate sodium	TABLET;ORAL	079049-001	Aug 4, 2008		DISCN	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

Subscribe to access the full database, or Try a Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-005	Oct 20, 2000	⤷ Try a Trial	⤷ Try a Trial
Merck	FOSAMAX	alendronate sodium	SOLUTION;ORAL	021575-001	Sep 17, 2003	⤷ Try a Trial	⤷ Try a Trial
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-005	Oct 20, 2000	⤷ Try a Trial	⤷ Try a Trial
Merck	FOSAMAX	alendronate sodium	SOLUTION;ORAL	021575-001	Sep 17, 2003	⤷ Try a Trial	⤷ Try a Trial
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-001	Sep 29, 1995	⤷ Try a Trial	⤷ Try a Trial
Merck	FOSAMAX	alendronate sodium	SOLUTION;ORAL	021575-001	Sep 17, 2003	⤷ Try a Trial	⤷ Try a Trial
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-001	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

Subscribe to access the full database, or Try a Trial
Country	Patent Number	Title	Estimated Expiration
South Africa	201302093	STABLE EFFERVESCENT BISPHOSPHONATE FORMULATIONS WITH RAPID SOLUBILIZATION CHARACTERISTICS	⤷ Try a Trial
South Korea	20170104664	신속한 용해 특성을 구비한 안정한 발포성 비스포스포네이트 제형 (STABLE EFFERVESCENT BISPHOSPHONATE FORMULATIONS WITH RAPID SOLUBILIZATION CHARACTERISTICS)	⤷ Try a Trial
Malaysia	166971	STABLE EFFERVESCENT BISPHOSPHONATE FORMULATIONS WITH RAPID SOLUBILIZATION CHARACTERISTICS	⤷ Try a Trial
Spain	2716525		⤷ Try a Trial
Portugal	2648702		⤷ Try a Trial
Israel	224367	תכשירי ביספוספונט יציבים תוססים עם תכונות מסיסות מהירה (Stable effervescent bisphosphonate formulations with rapid solubilization characteristics)	⤷ Try a Trial
Russian Federation	2013109765	СТАБИЛЬНЫЕ СОСТАВЫ ШИПУЧЕГО БИСФОСФОНАТА СО СВОЙСТВАМИ БЫСТРОЙ СОЛЮБИЛИЗАЦИИ	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for alendronate sodium

Subscribe to access the full database, or Try a Trial
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

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.