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Last Updated: November 4, 2024

DICYCLOMINE HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for dicyclomine hydrochloride and what is the scope of freedom to operate?

Dicyclomine hydrochloride is the generic ingredient in four branded drugs marketed by Allergan, Annora Pharma, Aurobindo Pharma Usa, Corepharma, Lannett, Pioneer Pharms, Prinston Inc, Sun Pharm Industries, Twi Pharms, Watson Labs, West Ward, Abbvie, Am Regent, Dr Reddys, Fosun Pharma, Fresenius Kabi Usa, Hikma, Nexus, Praxgen Pharms, Renew Pharms, Slate Run Pharma, Aptalis Pharma Us, Alpharma Us Pharms, Endo Operations, Novitium Pharma, Bionpharma, Hikma Pharms, and Rubicon, and is included in forty NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for dicyclomine hydrochloride. Fifty-five suppliers are listed for this compound.

Summary for DICYCLOMINE HYDROCHLORIDE

US Patents:	0
Tradenames:	4
Applicants:	28
NDAs:	40
Drug Master File Entries:	4
Finished Product Suppliers / Packagers:	55
Raw Ingredient (Bulk) Api Vendors:	63
Patent Applications:	1,516
What excipients (inactive ingredients) are in DICYCLOMINE HYDROCHLORIDE?	DICYCLOMINE HYDROCHLORIDE excipients list
DailyMed Link:	DICYCLOMINE HYDROCHLORIDE at DailyMed

Pharmacology for DICYCLOMINE HYDROCHLORIDE

Drug Class	Anticholinergic
Mechanism of Action	Cholinergic Antagonists

Medical Subject Heading (MeSH) Categories for DICYCLOMINE HYDROCHLORIDE

Muscarinic Antagonists
Parasympatholytics

US Patents and Regulatory Information for DICYCLOMINE HYDROCHLORIDE

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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
Pioneer Pharms	DICYCLOMINE HYDROCHLORIDE	dicyclomine hydrochloride	TABLET;ORAL	088585-001	Aug 20, 1986		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE FREE)	dicyclomine hydrochloride	INJECTABLE;INJECTION	040465-001	Jun 30, 2003	AP	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs	DICYCLOMINE HYDROCHLORIDE	dicyclomine hydrochloride	TABLET;ORAL	084361-001	Feb 6, 1986		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

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