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Last Updated: November 21, 2024

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, Xgen Pharms, Able, Annora Pharma, Cosette, Padagis Israel, Taro, Watson Labs Inc, Amneal Pharms, Chartwell Rx, Kv Pharm, Nostrum Labs Inc, Pharm Assoc, Quagen, Tris Pharma Inc, Whiteworth Town Plsn, Amneal Pharms Ny, Aurobindo Pharma Usa, Chartwell Molecular, Impax Labs, Invatech, Ivax Sub Teva Pharms, Kvk Tech, Prinston Inc, Pvt Form, Strides Pharma, Sun Pharm Inds Inc, Sun Pharm Industries, Tablicaps, Teva, Zydus Pharms Usa, Actavis Mid Atlantic, Wockhardt Bio Ag, and Ani Pharms. and is included in ninety NDAs.

The generic ingredient in PROMETHAZINE HYDROCHLORIDE is codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride. There are nineteen drug master file entries for this compound. Two suppliers are 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:	90
Finished Product Suppliers / Packagers:	47
Raw Ingredient (Bulk) Api Vendors:	94
Clinical Trials:	58
Patent Applications:	2,455
DailyMed Link:	PROMETHAZINE HYDROCHLORIDE at DailyMed

Drug patent expirations by year for PROMETHAZINE HYDROCHLORIDE

Recent Clinical Trials for PROMETHAZINE HYDROCHLORIDE

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Sponsor	Phase
National Trauma Center	N/A
Oman Medical Speciality Board	Phase 3
Tanta University	N/A

See all PROMETHAZINE HYDROCHLORIDE clinical trials

Pharmacology for PROMETHAZINE HYDROCHLORIDE

Drug Class	Phenothiazine

Medical Subject Heading (MeSH) Categories for PROMETHAZINE HYDROCHLORIDE

Anti-Allergic Agents
Antipruritics
Histamine H1 Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for PROMETHAZINE HYDROCHLORIDE

D04AA	Antihistamines for topical use
D04A	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D04	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D	Dermatologicals

R06AD	Phenothiazine derivatives
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

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
Invatech	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	TABLET;ORAL	085146-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Tablicaps	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	TABLET;ORAL	084027-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amneal Pharms	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	SYRUP;ORAL	040882-001	Dec 30, 2009		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Annora Pharma	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	SUPPOSITORY;RECTAL	216446-002	Nov 2, 2022	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Quagen	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	TABLET;ORAL	040673-002	Mar 5, 2008	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms Usa	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	TABLET;ORAL	040596-003	Nov 18, 2005	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Taro	PROMETHAZINE HYDROCHLORIDE	promethazine hydrochloride	SYRUP;ORAL	040718-001	Apr 4, 2007	AA	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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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. 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.