ACAMPROSATE CALCIUM - Generic Drug Details

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What are the generic sources for acamprosate calcium and what is the scope of freedom to operate?

Acamprosate calcium is the generic ingredient in two branded drugs marketed by Barr Labs Div Teva, Glenmark Pharms Ltd, Mylan, Zydus Pharms, and Forest Labs, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

There are six drug master file entries for acamprosate calcium. Six suppliers are listed for this compound.

Summary for ACAMPROSATE CALCIUM

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	5
Drug Master File Entries:	6
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	81
Clinical Trials:	7
Patent Applications:	983
What excipients (inactive ingredients) are in ACAMPROSATE CALCIUM?	ACAMPROSATE CALCIUM excipients list
DailyMed Link:	ACAMPROSATE CALCIUM at DailyMed

Recent Clinical Trials for ACAMPROSATE CALCIUM

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Technische Universität Dresden	Phase 3
Dayanand Medical College and Hospital	Phase 4
Synchroneuron Inc.	Phase 2

See all ACAMPROSATE CALCIUM clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ACAMPROSATE CALCIUM

N07BB	Drugs used in alcohol dependence
N07B	DRUGS USED IN ADDICTIVE DISORDERS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

US Patents and Regulatory Information for ACAMPROSATE CALCIUM

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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
Zydus Pharms	ACAMPROSATE CALCIUM	acamprosate calcium	TABLET, DELAYED RELEASE;ORAL	205995-001	May 26, 2017	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Glenmark Pharms Ltd	ACAMPROSATE CALCIUM	acamprosate calcium	TABLET, DELAYED RELEASE;ORAL	202229-001	Jul 16, 2013		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan	ACAMPROSATE CALCIUM	acamprosate calcium	TABLET, DELAYED RELEASE;ORAL	200142-001	Mar 11, 2014	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

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