Last Updated: September 28, 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, Hetero Labs Ltd Iii, and Rubicon Research. and is included in ninety-two NDAs.

The generic ingredient in PROMETHAZINE HYDROCHLORIDE is codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride. 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:	45
NDAs:	92

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
>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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.