Last Updated: August 2, 2026

PROMETHAZINE HYDROCHLORIDE Drug Patent Profile

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Which patents cover Promethazine Hydrochloride, and when can generic versions of Promethazine Hydrochloride launch?

Promethazine Hydrochloride is a drug marketed by Abbott, Am Regent, Bedford Labs, Epic Pharma Llc, Hikma, Hospira, Marsam Pharms Llc, Mylan Institutional, Sandoz, Teva Pharms Usa, Watson Labs, Wockhardt Bio Ag, Xgen Pharms, Able, Annora Pharma, Cosette Pharms Nc, Padagis Israel, Sun Pharma Canada, Watson Labs Inc, Amneal Pharms, Chartwell Rx, Kv Pharm, Pharm Assoc, Quagen, Strides Pharma, Whiteworth Town Plsn, Amneal Pharms Ny, Aurobindo Pharma Usa, Chartwell Molecular, Impax Labs, Ivax Sub Teva Pharms, Kvk Tech, Prinston Inc, Pvt Form, Rising, Sun Pharm Inds Inc, Sun Pharm Industries, Tablicaps, Teva, Zydus Pharms Usa, Actavis Mid Atlantic, Pharmobedient, Ani Pharms, and Hetero Labs Ltd Iii. and is included in ninety-one NDAs.

The generic ingredient in PROMETHAZINE HYDROCHLORIDE is codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride. There are nineteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride profile page.

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Summary for PROMETHAZINE HYDROCHLORIDE

US Patents:	0
Applicants:	44
NDAs:	91

US Patents and Regulatory Information for PROMETHAZINE 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
Ivax Sub Teva Pharms	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	TABLET;ORAL	083603-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Tablicaps	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	TABLET;ORAL	084027-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Amneal Pharms	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	SYRUP;ORAL	040882-001	Dec 30, 2009		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Annora Pharma	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	SUPPOSITORY;RECTAL	216446-002	Nov 2, 2022	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Rising	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	TABLET;ORAL	085146-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Zydus Pharms Usa	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	TABLET;ORAL	040596-003	Nov 18, 2005	AB	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>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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