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Last Updated: September 25, 2020

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CLONIDINE Drug Profile

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When do Clonidine patents expire, and when can generic versions of Clonidine launch?

Clonidine is a drug marketed by Actavis Labs Ut Inc, Aveva, Mayne Pharma, Mylan Technologies, Tris Pharma Inc, Am Regent, Fresenius Kabi Usa, Hikma Farmaceutica, Xgen Pharms, Zydus Pharms, Actavis Elizabeth, Ajanta Pharma Ltd, Amneal Pharms Ny, Anchen Pharms, Jubilant Generics, Lupin Ltd, Mayne Pharma Inc, Novast Labs, Upsher Smith Labs, Xiamen Lp Pharm Co, Alembic Pharms Ltd, Am Therap, Aurobindo Pharma Ltd, Chartwell Molecules, Duramed Pharms Barr, Frontida Biopharm, Impax Labs, Interpharm, Mylan, Par Pharm, Prinston Inc, Sun Pharm Inds Inc, Teva, Unichem, Warner Chilcott, Watson Labs, and Yung Shin Pharm. and is included in sixty-three NDAs. There are two patents protecting this drug.

This drug has twenty-one patent family members in fourteen countries.

The generic ingredient in CLONIDINE is chlorthalidone; clonidine hydrochloride. There are twenty-one drug master file entries for this compound. Additional details are available on the chlorthalidone; clonidine hydrochloride profile page.

US ANDA Litigation and Generic Entry Outlook for Clonidine

Annual sales in 2018 were $206mm indicating the motivation for generic entry (peak sales were $379mm in 2015).

Indicators of Generic Entry

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Drug patent expirations by year for CLONIDINE
Drug Prices for CLONIDINE

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Drug Sales Revenue Trends for CLONIDINE

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Recent Clinical Trials for CLONIDINE

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SponsorPhase
Toronto General HospitalPhase 3
Sinai Health SystemPhase 3
University Health Network, TorontoPhase 3

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Pharmacology for CLONIDINE
Medical Subject Heading (MeSH) Categories for CLONIDINE
Paragraph IV (Patent) Challenges for CLONIDINE
Tradename Dosage Ingredient NDA Submissiondate
CATAPRES-TTS-2 FILM, EXTENDED RELEASE;TRANSDERMAL clonidine 018891
CATAPRES-TTS-3 FILM, EXTENDED RELEASE;TRANSDERMAL clonidine 018891
CATAPRES-TTS-1 FILM, EXTENDED RELEASE;TRANSDERMAL clonidine 018891

US Patents and Regulatory Information for CLONIDINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET;ORAL 070317-003 Jun 9, 1987 AB RX No No   Start Trial   Start Trial   Start Trial
Par Pharm CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE chlorthalidone; clonidine hydrochloride TABLET;ORAL 071179-001 Dec 16, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Novast Labs CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209675-001 Mar 5, 2019 AB1 RX No No   Start Trial   Start Trial   Start Trial
Ajanta Pharma Ltd CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET, EXTENDED RELEASE;ORAL 209686-001 Nov 20, 2017 AB1 RX No No   Start Trial   Start Trial   Start Trial
Unichem CLONIDINE HYDROCHLORIDE clonidine hydrochloride TABLET;ORAL 078895-001 Aug 26, 2009 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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