Dicyclomine hydrochloride - Generic Drug Details

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What are the generic sources for dicyclomine hydrochloride and what is the scope of patent protection?

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-four 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:	54
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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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
Watson Labs	DICYCLOMINE HYDROCHLORIDE	dicyclomine hydrochloride	CAPSULE;ORAL	085082-001	Jun 19, 1986	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rubicon	DICYCLOMINE HYDROCHLORIDE	dicyclomine hydrochloride	TABLET;ORAL	216736-001	Dec 14, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novitium Pharma	DICYCLOMINE HYDROCHLORIDE	dicyclomine hydrochloride	SYRUP;ORAL	214721-001	Apr 23, 2021	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	DICYCLOMINE HYDROCHLORIDE	dicyclomine hydrochloride	SYRUP;ORAL	212286-001	May 22, 2020	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Endo Operations	DICYCLOMINE HYDROCHLORIDE	dicyclomine hydrochloride	SYRUP;ORAL	040169-001	Mar 24, 2005	AA	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fosun Pharma	DICYCLOMINE HYDROCHLORIDE	dicyclomine hydrochloride	INJECTABLE;INJECTION	210979-001	Jul 2, 2018	AP	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fresenius Kabi Usa	DICYCLOMINE HYDROCHLORIDE	dicyclomine hydrochloride	INJECTABLE;INJECTION	210257-001	Jan 25, 2019	AP	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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