Alendronate sodium - Generic Drug Details

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What are the generic drug 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, 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

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
University of California, Davis	Phase 2
National Heart, Lung, and Blood Institute (NHLBI)	Phase 2
Doris Duke Charitable Foundation	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

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Glossary

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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	090124-002	Aug 4, 2008	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	ALENDRONATE SODIUM	alendronate sodium	TABLET;ORAL	078638-001	Aug 4, 2008		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Jubilant Cadista	ALENDRONATE SODIUM	alendronate sodium	TABLET;ORAL	090557-004	Feb 18, 2010		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms	ALENDRONATE SODIUM	alendronate sodium	TABLET;ORAL	076184-001	Feb 6, 2008		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Aurobindo Pharma	ALENDRONATE SODIUM	alendronate sodium	TABLET;ORAL	090124-001	Aug 4, 2008	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rising	ALENDRONATE SODIUM	alendronate sodium	TABLET;ORAL	076584-004	Aug 4, 2008		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	ALENDRONATE SODIUM	alendronate sodium	TABLET;ORAL	078638-002	Aug 4, 2008		DISCN	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

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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
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-005	Oct 20, 2000	⤷ Sign Up	⤷ Sign Up
Organon	FOSAMAX	alendronate sodium	TABLET;ORAL	020560-005	Oct 20, 2000	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for alendronate sodium

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Country	Patent Number	Title	Estimated Expiration
China	103140220	Stable effervescent bisphosphonate formulations with rapid solubilization characteristics	⤷ 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
Portugal	2648702		⤷ Sign Up
Turkey	201903835		⤷ Sign Up
Brazil	112013010476	formulações efervescentes estáveis de bisfosfonato com características de solubilização rápida	⤷ Sign Up
Russian Federation	2608724	СТАБИЛЬНЫЕ СОСТАВЫ ШИПУЧЕГО БИСФОСФОНАТА СО СВОЙСТВАМИ БЫСТРОЙ СОЛЮБИЛИЗАЦИИ (STABLE FORMULATIONS OF EFFERVESCENT BISPHOSPHONATE WITH PROPERTIES OF FAST SOLUBILIZATION)	⤷ Sign Up
South Korea	20180115254	신속한 용해 특성을 구비한 안정한 발포성 비스포스포네이트 제형 (STABLE EFFERVESCENT BISPHOSPHONATE FORMULATIONS WITH RAPID SOLUBILIZATION CHARACTERISTICS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for alendronate sodium

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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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