November 2024 - Cytochrome P450 1A2 Inhibitors drug patent information, international generic entry, market access

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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
Rubicon	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	TABLET;ORAL	078578-002	Feb 26, 2021	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Gland Pharma Ltd	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	INJECTABLE;INJECTION	077161-001	Apr 20, 2005	AP	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys Labs Sa	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	TABLET;ORAL	075389-001	Jan 25, 2001	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fresenius Kabi Usa	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	INJECTABLE;INJECTION	075761-001	Oct 15, 2002	AP	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rubicon	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	TABLET;ORAL	078578-001	Nov 6, 2008	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms Usa Inc	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	TABLET;ORAL	079029-002	Jan 6, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dr Reddys Labs Sa	AMIODARONE HYDROCHLORIDE	amiodarone hydrochloride	TABLET;ORAL	075389-003	Dec 28, 2017	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