Is there a generic for Clonidine hydrochloride?

Yes. The FDA Orange Book lists 54 approved generic (ANDA) applications for Clonidine hydrochloride, referencing the brand JAVADIN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Clonidine hydrochloride?

JAVADIN (NDA 220256, AZURITY) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Clonidine hydrochloride?

The Orange Book lists 5 patents against Clonidine hydrochloride products, with the earliest listed expiry in 2029. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Clonidine hydrochloride are approved?

Clonidine hydrochloride is approved in the following dosage forms: injectable, solution, suspension, extended release, tablet, tablet, extended release.

FDA Orange Book · active-ingredient family

Clonidine hydrochloride

Clonidine hydrochloride: 5 brands, 54 generics; first approved Jul 08, 1986; generic available.

Generic availableHas discontinued products

Generic status & protection

Generic available: 54 ANDA applications approved.

Earliest patent expiry Mar 29, 2029

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Mar 29, 2029

in 2 yr 8 mo

Brand (NDA) products

Originator applications

JAVADINRLDRS
AZURITYNDA 2202562025
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.02MG/ML SOLUTION ORAL Rx —
ONYDA XRRLDRS
TRIS PHARMA INCNDA 2176452024
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG/ML SUSPENSION, EXTENDED RELEASE ORAL Rx —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.02MG/ML	SOLUTION	ORAL	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG/ML	SUSPENSION, EXTENDED RELEASE	ORAL	Rx	—

JENLOGARLD

CONCORDIA PHARMS INCNDA 02233120094 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	—
0.2MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	—
0.1MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	—
0.2MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	—

DURACLONRLD
MYLAN INSTITUTIONALNDA 02061519962 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/10ML (0.1MG/ML) INJECTABLE INJECTION Rx AP
5MG/10ML (0.5MG/ML) INJECTABLE INJECTION Discontinued —
CATAPRESRLD
BOEHRINGER INGELHEIMNDA 017407—3 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET ORAL Discontinued —
0.2MG TABLET ORAL Discontinued —
0.3MG TABLET ORAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/10ML (0.1MG/ML)	INJECTABLE	INJECTION	Rx	AP
5MG/10ML (0.5MG/ML)	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG	TABLET	ORAL	Discontinued	—
0.2MG	TABLET	ORAL	Discontinued	—
0.3MG	TABLET	ORAL	Discontinued	—

Generic (ANDA) products (54)

Abbreviated applications

CLONIDINE HYDROCHLORIDERS
TP ANDA HOLDINGSANDA 07092320264 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.3MG TABLET ORAL Rx AB
0.2MG TABLET ORAL Rx AB
0.1MG TABLET ORAL Rx AB
0.05MG TABLET ORAL Rx —
CLONIDINE HYDROCHLORIDE
NOVAST LABSANDA 2096752019
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET, EXTENDED RELEASE ORAL Rx AB1
CLONIDINE HYDROCHLORIDE
SOMERSET THERAPS LLCANDA 2114332018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET, EXTENDED RELEASE ORAL Rx AB1
CLONIDINE HYDROCHLORIDE
RUBICON RESEARCHANDA 2106802018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET, EXTENDED RELEASE ORAL Discontinued —
CLONIDINE HYDROCHLORIDE
JUBILANT GENERICSANDA 2103382018
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET, EXTENDED RELEASE ORAL Rx AB1
CLONIDINE HYDROCHLORIDERS
AJANTA PHARMA LTDANDA 2096862017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET, EXTENDED RELEASE ORAL Rx AB1
CLONIDINE HYDROCHLORIDE
AMNEAL PHARMS NYANDA 2100522017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET, EXTENDED RELEASE ORAL Discontinued —
CLONIDINE HYDROCHLORIDE
XIAMEN LP PHARM COANDA 2097572017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET, EXTENDED RELEASE ORAL Rx AB1
CLONIDINE HYDROCHLORIDE
CHARTWELL RXANDA 2092852017
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET, EXTENDED RELEASE ORAL Rx AB1
CLONIDINE HYDROCHLORIDE
ACTAVIS ELIZABETHANDA 20279220152 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET, EXTENDED RELEASE ORAL Discontinued —
0.2MG TABLET, EXTENDED RELEASE ORAL Discontinued —
CLONIDINE HYDROCHLORIDE
ACTAVIS ELIZABETHANDA 20332020152 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET, EXTENDED RELEASE ORAL Rx AB1
0.2MG TABLET, EXTENDED RELEASE ORAL Discontinued —
CLONIDINE HYDROCHLORIDE
SUN PHARM INDS INCANDA 09032920143 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET ORAL Discontinued —
0.2MG TABLET ORAL Discontinued —
0.3MG TABLET ORAL Discontinued —
CLONIDINE HYDROCHLORIDE
PH HEALTHANDA 20298320142 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET, EXTENDED RELEASE ORAL Discontinued —
0.2MG TABLET, EXTENDED RELEASE ORAL Discontinued —
CLONIDINE HYDROCHLORIDE
ZYDUS PHARMSANDA 20260120142 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/10ML (0.1MG/ML) INJECTABLE INJECTION Rx AP
5MG/10ML (0.5MG/ML) INJECTABLE INJECTION Rx AP
CLONIDINE HYDROCHLORIDE
XGEN PHARMSANDA 20316720132 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/10ML (0.1MG/ML) INJECTABLE INJECTION Rx AP
5MG/10ML (0.5MG/ML) INJECTABLE INJECTION Rx AP
CLONIDINE HYDROCHLORIDE
PH HEALTHANDA 20298420132 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET, EXTENDED RELEASE ORAL Discontinued —
0.2MG TABLET, EXTENDED RELEASE ORAL Discontinued —
CLONIDINE HYDROCHLORIDE
YUNG SHIN PHARMANDA 20229720133 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET ORAL Rx AB
0.2MG TABLET ORAL Rx AB
0.3MG TABLET ORAL Rx AB
CLONIDINE HYDROCHLORIDE
ALEMBIC PHARMS LTDANDA 09136820113 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET ORAL Rx AB
0.2MG TABLET ORAL Rx AB
0.3MG TABLET ORAL Rx AB
CLONIDINE HYDROCHLORIDE
FRESENIUS KABI USAANDA 20067320112 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/10ML (0.1MG/ML) INJECTABLE INJECTION Rx AP
5MG/10ML (0.5MG/ML) INJECTABLE INJECTION Rx AP
CLONIDINE HYDROCHLORIDE
HIKMA FARMACEUTICAANDA 20030020112 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/10ML (0.1MG/ML) INJECTABLE INJECTION Rx AP
5MG/10ML (0.5MG/ML) INJECTABLE INJECTION Rx AP
CLONIDINE HYDROCHLORIDE
AM REGENTANDA 09110420092 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
1MG/10ML (0.1MG/ML) INJECTABLE INJECTION Discontinued —
5MG/10ML (0.5MG/ML) INJECTABLE INJECTION Discontinued —
CLONIDINE HYDROCHLORIDE
IMPAX LABSANDA 07809920093 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET ORAL Rx AB
0.2MG TABLET ORAL Rx AB
0.3MG TABLET ORAL Rx AB
CLONIDINE HYDROCHLORIDE
UNICHEMANDA 07889520093 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET ORAL Rx AB
0.2MG TABLET ORAL Rx AB
0.3MG TABLET ORAL Rx AB
CLONIDINE HYDROCHLORIDE
PRINSTON INCANDA 07790120073 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET ORAL Rx AB
0.2MG TABLET ORAL Rx AB
0.3MG TABLET ORAL Rx AB
CLONIDINE HYDROCHLORIDE
AUROBINDO PHARMA LTDANDA 07088619883 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.2MG TABLET ORAL Rx AB
0.1MG TABLET ORAL Rx AB
0.3MG TABLET ORAL Rx AB
CLONIDINE HYDROCHLORIDE
WARNER CHILCOTTANDA 0721381988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET ORAL Discontinued —
CLONIDINE HYDROCHLORIDE
WARNER CHILCOTTANDA 0721391988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.2MG TABLET ORAL Discontinued —
CLONIDINE HYDROCHLORIDE
WARNER CHILCOTTANDA 0721401988
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.3MG TABLET ORAL Discontinued —
CLONIDINE HYDROCHLORIDE
CHARTWELL MOLECULESANDA 07178519883 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.3MG TABLET ORAL Rx AB
0.1MG TABLET ORAL Rx AB
0.2MG TABLET ORAL Rx AB
CLONIDINE HYDROCHLORIDE
RISINGANDA 07031719873 strengths
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.3MG TABLET ORAL Discontinued —
0.1MG TABLET ORAL Discontinued —
0.2MG TABLET ORAL Discontinued —
CLONIDINE HYDROCHLORIDE
WATSON LABSANDA 0703951987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET ORAL Discontinued —
CLONIDINE HYDROCHLORIDE
WATSON LABSANDA 0703961987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.2MG TABLET ORAL Discontinued —
CLONIDINE HYDROCHLORIDE
WATSON LABSANDA 0703971987
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.3MG TABLET ORAL Discontinued —
CLONIDINE HYDROCHLORIDE
ACTAVIS ELIZABETHANDA 0709741986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET ORAL Rx AB
CLONIDINE HYDROCHLORIDE
ACTAVIS ELIZABETHANDA 0709751986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.2MG TABLET ORAL Rx AB
CLONIDINE HYDROCHLORIDE
ACTAVIS ELIZABETHANDA 0709761986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.3MG TABLET ORAL Rx AB
CLONIDINE HYDROCHLORIDE
INTERPHARMANDA 0712521986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET ORAL Discontinued —
CLONIDINE HYDROCHLORIDE
INTERPHARMANDA 0712531986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.2MG TABLET ORAL Discontinued —
CLONIDINE HYDROCHLORIDE
INTERPHARMANDA 0712541986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.3MG TABLET ORAL Discontinued —
CLONIDINE HYDROCHLORIDE
DURAMED PHARMS BARRANDA 0711031986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET ORAL Discontinued —
CLONIDINE HYDROCHLORIDE
DURAMED PHARMS BARRANDA 0711021986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.2MG TABLET ORAL Discontinued —
CLONIDINE HYDROCHLORIDE
DURAMED PHARMS BARRANDA 0711011986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.3MG TABLET ORAL Discontinued —
CLONIDINE HYDROCHLORIDE
AM THERAPANDA 0708811986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET ORAL Discontinued —
CLONIDINE HYDROCHLORIDE
AM THERAPANDA 0708821986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.2MG TABLET ORAL Discontinued —
CLONIDINE HYDROCHLORIDE
AM THERAPANDA 0708831986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.3MG TABLET ORAL Discontinued —
CLONIDINE HYDROCHLORIDE
PAR PHARMANDA 0704611986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET ORAL Discontinued —
CLONIDINE HYDROCHLORIDE
PAR PHARMANDA 0704601986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.2MG TABLET ORAL Discontinued —
CLONIDINE HYDROCHLORIDE
PAR PHARMANDA 0704591986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.3MG TABLET ORAL Discontinued —
CLONIDINE HYDROCHLORIDE
TEVAANDA 0707471986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET ORAL Discontinued —
CLONIDINE HYDROCHLORIDE
TEVAANDA 0707021986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.2MG TABLET ORAL Discontinued —
CLONIDINE HYDROCHLORIDE
TEVAANDA 0706591986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.3MG TABLET ORAL Discontinued —
CLONIDINE HYDROCHLORIDE
WATSON LABSANDA 0709651986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.1MG TABLET ORAL Discontinued —
CLONIDINE HYDROCHLORIDE
WATSON LABSANDA 0709641986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.2MG TABLET ORAL Discontinued —
CLONIDINE HYDROCHLORIDE
WATSON LABSANDA 0709631986
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
0.3MG TABLET ORAL Discontinued —

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.3MG	TABLET	ORAL	Rx	AB
0.2MG	TABLET	ORAL	Rx	AB
0.1MG	TABLET	ORAL	Rx	AB
0.05MG	TABLET	ORAL	Rx	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB1

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB1

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB1

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB1

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB1

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB1

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG	TABLET, EXTENDED RELEASE	ORAL	Rx	AB1
0.2MG	TABLET, EXTENDED RELEASE	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG	TABLET	ORAL	Discontinued	—
0.2MG	TABLET	ORAL	Discontinued	—
0.3MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/10ML (0.1MG/ML)	INJECTABLE	INJECTION	Rx	AP
5MG/10ML (0.5MG/ML)	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/10ML (0.1MG/ML)	INJECTABLE	INJECTION	Rx	AP
5MG/10ML (0.5MG/ML)	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG	TABLET	ORAL	Rx	AB
0.2MG	TABLET	ORAL	Rx	AB
0.3MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG	TABLET	ORAL	Rx	AB
0.2MG	TABLET	ORAL	Rx	AB
0.3MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/10ML (0.1MG/ML)	INJECTABLE	INJECTION	Rx	AP
5MG/10ML (0.5MG/ML)	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/10ML (0.1MG/ML)	INJECTABLE	INJECTION	Rx	AP
5MG/10ML (0.5MG/ML)	INJECTABLE	INJECTION	Rx	AP

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
1MG/10ML (0.1MG/ML)	INJECTABLE	INJECTION	Discontinued	—
5MG/10ML (0.5MG/ML)	INJECTABLE	INJECTION	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG	TABLET	ORAL	Rx	AB
0.2MG	TABLET	ORAL	Rx	AB
0.3MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG	TABLET	ORAL	Rx	AB
0.2MG	TABLET	ORAL	Rx	AB
0.3MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG	TABLET	ORAL	Rx	AB
0.2MG	TABLET	ORAL	Rx	AB
0.3MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2MG	TABLET	ORAL	Rx	AB
0.1MG	TABLET	ORAL	Rx	AB
0.3MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.3MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.3MG	TABLET	ORAL	Rx	AB
0.1MG	TABLET	ORAL	Rx	AB
0.2MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.3MG	TABLET	ORAL	Discontinued	—
0.1MG	TABLET	ORAL	Discontinued	—
0.2MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.3MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.3MG	TABLET	ORAL	Rx	AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.3MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.3MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.1MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.2MG	TABLET	ORAL	Discontinued	—

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
0.3MG	TABLET	ORAL	Discontinued	—

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8062667	Mar 29, 2029	in 2 yr 8 mo	Product
11918689	Jul 28, 2041	in 15 yr 2 mo	ProductU-3944
12576032	Jul 28, 2041	in 15 yr 2 mo	U-2357
12233049	Jul 15, 2042	in 16 yr 1 mo	Product
12440474	Jul 15, 2042	in 16 yr 1 mo	Product

Approval history

FDA approval span

First approval

Jul 08, 1986

40 yr 9 mo ago

Most recent approval

Apr 06, 2026

5 mo ago

Approvals span 1986–2026 across 59 FDA applications.

Brand (NDA) 58%

Generic (ANDA) 5492%

Clonidine hydrochloride: frequently asked questions

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

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Related FDA reference tools

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo