FDA Orange Book · active-ingredient family
Clonidine
Clonidine: 3 brands, 4 generics; first approved Oct 10, 1984; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 4 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
3
Generics (ANDA)
4
Listed patents
2
Next patent expiry
Apr 17, 2027
in 8 mo
Brand (NDA) products
Originator applications
- LAVIPHARMNDA 01889119843 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1MG/24HR SYSTEM TRANSDERMAL Rx AB 0.2MG/24HR SYSTEM TRANSDERMAL Rx AB 0.3MG/24HR SYSTEM TRANSDERMAL Rx AB - CLONIDINETRIS PHARMA INCNDA 0224992009
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.09MG BASE/ML SUSPENSION, EXTENDED RELEASE ORAL Discontinued — - ROSEMONTNDA 02250020092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 0.17MG BASE TABLET, EXTENDED RELEASE ORAL Rx — EQ 0.26MG BASE TABLET, EXTENDED RELEASE ORAL Discontinued —
Generic (ANDA) products (4)
Abbreviated applications
- CLONIDINEACTAVIS LABS UT INCANDA 09087320143 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1MG/24HR SYSTEM TRANSDERMAL Rx AB 0.2MG/24HR SYSTEM TRANSDERMAL Rx AB 0.3MG/24HR SYSTEM TRANSDERMAL Rx AB - CLONIDINEDR REDDYS LABS SAANDA 07909020103 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1MG/24HR SYSTEM TRANSDERMAL Rx AB 0.2MG/24HR SYSTEM TRANSDERMAL Rx AB 0.3MG/24HR SYSTEM TRANSDERMAL Rx AB - CLONIDINEMYLAN TECHNOLOGIESANDA 07616620103 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1MG/24HR SYSTEM TRANSDERMAL Rx AB 0.2MG/24HR SYSTEM TRANSDERMAL Rx AB 0.3MG/24HR SYSTEM TRANSDERMAL Rx AB - CLONIDINEDIFGEN PHARMSANDA 07615720093 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 0.1MG/24HR SYSTEM TRANSDERMAL Discontinued — 0.2MG/24HR SYSTEM TRANSDERMAL Discontinued — 0.3MG/24HR SYSTEM TRANSDERMAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8337890 | in 8 mo | Product | |
| 8623409 | in 5 yr 1 mo | Product |
Approval history
FDA approval span
First approval
42 yr 6 mo ago
Most recent approval
12 yr 6 mo ago
Approvals span 1984–2014 across 7 FDA applications.
Brand (NDA) 343%
Generic (ANDA) 457%
Clonidine: 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
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
