Assyro AI

FDA Orange Book · active-ingredient family

Clonidine hydrochloride

Clonidine hydrochloride is approved as 5 brand and 54 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:JAVADIN · NDA 220256

5

Brand (NDA)

54

Generics (ANDA)

5

Listed patents

0

Exclusivity periods

Brand (NDA) products · injectable, solution, suspension, extended release, tablet, tablet, extended release

ProductApplicantApplicationTEApproved
JAVADINRLDAZURITYNDA 220256—Oct 23, 2025
ONYDA XRRLDTRIS PHARMA INCNDA 217645—May 24, 2024
JENLOGARLD×4CONCORDIA PHARMS INCNDA 022331—Sep 30, 2009
DURACLONRLD×2MYLAN INSTITUTIONALNDA 020615APOct 02, 1996
CATAPRESRLD×3BOEHRINGER INGELHEIMNDA 017407—Approved Prior to Jan 1, 1982

Generic (ANDA) products (54)

ProductApplicantApplicationTEApproved
CLONIDINE HYDROCHLORIDE×4TP ANDA HOLDINGSANDA 070923—Apr 06, 2026
CLONIDINE HYDROCHLORIDENOVAST LABSANDA 209675AB1Mar 05, 2019
CLONIDINE HYDROCHLORIDESOMERSET THERAPS LLCANDA 211433AB1Oct 12, 2018
CLONIDINE HYDROCHLORIDERUBICON RESEARCHANDA 210680—Apr 30, 2018
CLONIDINE HYDROCHLORIDEJUBILANT GENERICSANDA 210338AB1Jan 29, 2018
CLONIDINE HYDROCHLORIDEAJANTA PHARMA LTDANDA 209686AB1Nov 20, 2017
CLONIDINE HYDROCHLORIDEAMNEAL PHARMS NYANDA 210052—Nov 20, 2017
CLONIDINE HYDROCHLORIDEXIAMEN LP PHARM COANDA 209757AB1Nov 20, 2017
CLONIDINE HYDROCHLORIDECHARTWELL RXANDA 209285AB1Oct 23, 2017
CLONIDINE HYDROCHLORIDE×2ACTAVIS ELIZABETHANDA 202792—May 15, 2015
CLONIDINE HYDROCHLORIDE×2ACTAVIS ELIZABETHANDA 203320AB1May 15, 2015
CLONIDINE HYDROCHLORIDE×3SUN PHARM INDS INCANDA 090329—Jul 03, 2014
CLONIDINE HYDROCHLORIDE×2PH HEALTHANDA 202983—Apr 02, 2014
CLONIDINE HYDROCHLORIDE×2ZYDUS PHARMSANDA 202601APFeb 20, 2014
CLONIDINE HYDROCHLORIDE×2XGEN PHARMSANDA 203167APOct 29, 2013
CLONIDINE HYDROCHLORIDE×2PH HEALTHANDA 202984—Sep 30, 2013
CLONIDINE HYDROCHLORIDE×3YUNG SHIN PHARMANDA 202297ABJun 13, 2013
CLONIDINE HYDROCHLORIDE×3ALEMBIC PHARMS LTDANDA 091368ABDec 06, 2011
CLONIDINE HYDROCHLORIDE×2FRESENIUS KABI USAANDA 200673APJul 08, 2011
CLONIDINE HYDROCHLORIDE×2HIKMA FARMACEUTICAANDA 200300APJan 26, 2011
CLONIDINE HYDROCHLORIDE×2AM REGENTANDA 091104—Oct 08, 2009
CLONIDINE HYDROCHLORIDE×3IMPAX LABSANDA 078099ABAug 27, 2009
CLONIDINE HYDROCHLORIDE×3UNICHEMANDA 078895ABAug 26, 2009
CLONIDINE HYDROCHLORIDE×3PRINSTON INCANDA 077901ABMar 09, 2007
CLONIDINE HYDROCHLORIDE×3AUROBINDO PHARMA LTDANDA 070886ABAug 31, 1988
CLONIDINE HYDROCHLORIDEWARNER CHILCOTTANDA 072138—Jun 13, 1988
CLONIDINE HYDROCHLORIDEWARNER CHILCOTTANDA 072139—Jun 13, 1988
CLONIDINE HYDROCHLORIDEWARNER CHILCOTTANDA 072140—Jun 13, 1988
CLONIDINE HYDROCHLORIDE×3CHARTWELL MOLECULESANDA 071785ABApr 05, 1988
CLONIDINE HYDROCHLORIDE×3RISINGANDA 070317—Jul 09, 1987
CLONIDINE HYDROCHLORIDEWATSON LABSANDA 070395—Mar 23, 1987
CLONIDINE HYDROCHLORIDEWATSON LABSANDA 070396—Mar 23, 1987
CLONIDINE HYDROCHLORIDEWATSON LABSANDA 070397—Mar 23, 1987
CLONIDINE HYDROCHLORIDEACTAVIS ELIZABETHANDA 070974ABDec 16, 1986
CLONIDINE HYDROCHLORIDEACTAVIS ELIZABETHANDA 070975ABDec 16, 1986
CLONIDINE HYDROCHLORIDEACTAVIS ELIZABETHANDA 070976ABDec 16, 1986
CLONIDINE HYDROCHLORIDEINTERPHARMANDA 071252—Oct 01, 1986
CLONIDINE HYDROCHLORIDEINTERPHARMANDA 071253—Oct 01, 1986
CLONIDINE HYDROCHLORIDEINTERPHARMANDA 071254—Oct 01, 1986
CLONIDINE HYDROCHLORIDEDURAMED PHARMS BARRANDA 071103—Aug 14, 1986
CLONIDINE HYDROCHLORIDEDURAMED PHARMS BARRANDA 071102—Aug 14, 1986
CLONIDINE HYDROCHLORIDEDURAMED PHARMS BARRANDA 071101—Aug 14, 1986
CLONIDINE HYDROCHLORIDEAM THERAPANDA 070881—Jul 08, 1986
CLONIDINE HYDROCHLORIDEAM THERAPANDA 070882—Jul 08, 1986
CLONIDINE HYDROCHLORIDEAM THERAPANDA 070883—Jul 08, 1986
CLONIDINE HYDROCHLORIDEPAR PHARMANDA 070461—Jul 08, 1986
CLONIDINE HYDROCHLORIDEPAR PHARMANDA 070460—Jul 08, 1986
CLONIDINE HYDROCHLORIDEPAR PHARMANDA 070459—Jul 08, 1986
CLONIDINE HYDROCHLORIDETEVAANDA 070747—Jul 08, 1986
CLONIDINE HYDROCHLORIDETEVAANDA 070702—Jul 08, 1986
CLONIDINE HYDROCHLORIDETEVAANDA 070659—Jul 08, 1986
CLONIDINE HYDROCHLORIDEWATSON LABSANDA 070965—Jul 08, 1986
CLONIDINE HYDROCHLORIDEWATSON LABSANDA 070964—Jul 08, 1986
CLONIDINE HYDROCHLORIDEWATSON LABSANDA 070963—Jul 08, 1986

Listed patents (5)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8062667Mar 29, 2029in 2 yr 10 mo
Product
11918689Jul 28, 2041in 15 yr 4 mo
ProductU-3944
12576032Jul 28, 2041in 15 yr 4 mo
U-2357
12233049Jul 15, 2042in 16 yr 4 mo
Product
12440474Jul 15, 2042in 16 yr 4 mo
Product

Clonidine hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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