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FDA Orange Book · active-ingredient family

Bupropion hydrochloride; naltrexone hydrochloride

Bupropion hydrochloride; naltrexone hydrochloride: 1 brand, 0 generics; first approved Sep 10, 2014; on patent until Jun 04, 2027.

On patent
Generic status & protection

Protected until Jun 04, 2027 (earliest listed patent expiry).

Earliest patent expiry Jun 04, 2027
Brands (NDA)
1
Generics (ANDA)
0
Listed patents
18
Next patent expiry
Jun 04, 2027
in 11 mo
Originator applications

Brand (NDA) products

CONTRAVERLDRS
NDA 2000632014
Approved strengths under this FDA application.
StrengthDosage formRouteStatusTE
90MG;8MGTABLET, EXTENDED RELEASEORALRx—
Protection horizon

Patent & exclusivity timeline

2026202720282029203020312032203320342035TodayPatent 9107837 — 2027-06-04Patent 9107837Patent 8722085 — 2027-11-08Patent 8722085Patent 9125868 — 2027-11-08Patent 9125868Patent 10307376 — 2027-11-08Patent 10307376Patent 12048769 — 2027-11-08Patent 12048769Patent 8318788 — 2027-11-08Patent 8318788Patent 8088786 — 2029-02-03Patent 8088786Patent 11324741 — 2029-05-29Patent 11324741Patent 8916195 — 2030-02-02Patent 8916195Patent 11033543 — 2031-01-10Patent 11033543Patent 9248123 — 2032-01-13Patent 9248123Patent 11139056 — 2033-06-05Patent 11139056Patent 10403170 — 2033-06-05Patent 10403170Patent 9633575 — 2033-06-25Patent 9633575Patent 10231964 — 2034-07-02Patent 10231964Patent 11998542 — 2034-07-02Patent 11998542Patent 10835527 — 2034-07-02Patent 10835527Patent 10828294 — 2034-07-02Patent 10828294
Patent expiryExclusivity endToday
Orange Book patent file

Listed patents

Listed patents (18)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9107837Jun 04, 2027in 11 mo
U-1639
8722085Nov 08, 2027in 1 yr 4 mo
U-1585
9125868Nov 08, 2027in 1 yr 4 mo
U-1585
10307376Nov 08, 2027in 1 yr 4 mo
U-1585
12048769Nov 08, 2027in 1 yr 4 mo
U-1585
8318788Nov 08, 2027in 1 yr 4 mo
U-1584
8088786Feb 03, 2029in 2 yr 7 mo
Product
11324741May 29, 2029in 2 yr 11 mo
U-1583
8916195Feb 02, 2030in 3 yr 7 mo
U-1639
11033543Jan 10, 2031in 4 yr 7 mo
U-1583
9248123Jan 13, 2032in 5 yr 7 mo
U-1808
11139056Jun 05, 2033in 7 yr
U-1583
10403170Jun 05, 2033in 7 yr
U-1583
9633575Jun 25, 2033in 7 yr 1 mo
U-1583
10231964Jul 02, 2034in 8 yr 1 mo
U-1583
11998542Jul 02, 2034in 8 yr 1 mo
U-1583
10835527Jul 02, 2034in 8 yr 1 mo
U-1583
10828294Jul 02, 2034in 8 yr 1 mo
U-1583
FDA approval span

Approval history

First approval
Sep 10, 2014
12 yr ago
Most recent approval
Sep 10, 2014
12 yr ago

All 1 application were approved in 2014.

Brand (NDA) 1100%
Generic (ANDA) 00%

Bupropion hydrochloride; naltrexone 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.

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