Buprenorphine
Sold as Subutex sublingual, Sovenor, Butrans, Sovetrin, Bupremed, Norbutrin, Sobrixa, Temgesic, Temgesic sublingual
(1S,2S,6R,14R,15R,16R)-5-(Cyclopropylmethyl)-16-[(2S)-2-hydroxy-3,3-dimethylbutan-2-yl]-15-methoxy-13-oxa-5-azahexacyclo[13.2.2.12,8.01,6.02,14.012,20]icosa-8(20),9,11-trien-11-ol
Drag to rotate. Structure from PubChem CID 644073.
Background
Registration
- Applicants
- 4
- Registrations
- 24
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Adcock Ingram Critical Care (Pty) Ltd3 of 8 cancelled | Subutex sublingual, Sobrixa, Temgesic, Temgesic sublingual | 0,4 mg, 1 ml, 2,0 mg, 8,0 mg, tablets | 330377, 330378, 330379, 600351, 600352, 600353, L0157, S0327 | S6 | None |
| Mundipharma (Pty) Ltd | Sovenor, Butrans | 5, 10, 20 | 410589, 410590, 410591, 480461, 480462, 480463 | S6 | None |
| Trinity Pharma (Pty) Ltd | Sovetrin, Bupremed, Norbutrin | 5, 10, 20 | 540224, 540225, 540226, 540227.224, 540228.225, 540229.226, 540230.224, 540231.225, 540232.226 | S6 | PIPIL |
| Reckitt Benckinser Pharmaceuticals (Pty) Ltd | Temgesic | 2 ml | L0158 | S6 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Subutex sublingual 0,4 MG EACH TABLET CONTAINS BUPRENORPHINE HYDROCHLORIDE EQUIVALENT TO BUPRENORPHINE 0,4 mg | 0,4 mg | 33037733/34/0377 | Cancelled | S6 | None |
| Subutex sublingual 2,0 MG EACH TABLET CONTAINS BUPRENORPHINE HYDROCHLORIDE EQUIVALENT TO BUPRENORPHINE 2,0 mg | 2,0 mg | 33037833/34/0378 | Cancelled | S6 | None |
| Subutex sublingual 8,0 MG EACH TABLET CONTAINS BUPRENORPHINE HYDROCHLORIDE EQUIVALENT TO BUPRENORPHINE 8,0 mg | 8,0 mg | 33037933/34/0379 | Cancelled | S6 | None |
| Sovenor 5 patch EACH PATCH CONTAINS BUPRENORPHINE 5,0 mg | 5Patch | 41058941/2.7/0589 | Registered | S6 | None |
| Sovenor 10 patch EACH PATCH CONTAINS BUPRENORPHINE 10,0 mg | 10Patch | 41059041/2.7/0590 | Registered | S6 | None |
| Sovenor 20 patch EACH PATCH CONTAINS BUPRENORPHINE 20,0 mg | 20Patch | 41059141/2.7/0591 | Registered | S6 | None |
| Butrans 5 EACH PATCH CONTAINS: BUPRENORPHINE 5,0 mg | 5 | 48046148/2.7/0461 | Registered | S6 | None |
| Butrans 10 EACH PATCH CONTAINS: BUPRENORPHINE 10,0 mg | 10 | 48046248/2.7/0462 | Registered | S6 | None |
| Butrans 20 EACH PATCH CONTAINS: BUPRENORPHINE 20,0 mg | 20 | 48046348/2.7/0463 | Registered | S6 | None |
| Sovetrin 5 EACH PATCH CONTAINS BUPRENORPHINE 5,0 mg | 5Transdermal patch | 54022454/2.7/0224Approved 8 October 2024 | Registered | S6 | PIPIL |
| Sovetrin 10 EACH PATCH CONTAINS BUPRENORPHINE 10,0 mg | 10Transdermal patch | 54022554/2.7/0225Approved 8 October 2024 | Registered | S6 | PIPIL |
| Sovetrin 20 EACH PATCH CONTAINS BUPRENORPHINE 20,0 mg | 20Transdermal patch | 54022654/2.7/0226Approved 8 October 2024 | Registered | S6 | PIPIL |
| Bupremed 5 EACH PATCH CONTAINS BUPRENORPHINE 5,0 mg | 5Transdermal patch | 540227.22454/2.7/0227.224Approved 8 October 2024 | Old Medicine | S6 | PIPIL |
| Bupremed 10 EACH PATCH CONTAINS BUPRENORPHINE 10,0 mg | 10Transdermal patch | 540228.22554/2.7/0228.225Approved 8 October 2024 | Registered | S6 | PIPIL |
| Bupremed 20 EACH PATCH CONTAINS BUPRENORPHINE 20,0 mg | 20Transdermal patch | 540229.22654/2.7/0229.226Approved 8 October 2024 | Registered | S6 | PIPIL |
| Norbutrin 5 EACH PATCH CONTAINS BUPRENORPHINE 5,0 mg | 5Transdermal patch | 540230.22454/2.7/0230.224Approved 8 October 2024 | Registered | S6 | PIPIL |
| Norbutrin 10 EACH PATCH CONTAINS BUPRENORPHINE 10,0 mg | 10Transdermal patch | 540231.22554/2.7/0231.225Approved 8 October 2024 | Registered | S6 | PIPIL |
| Norbutrin 20 EACH PATCH CONTAINS BUPRENORPHINE 20,0 mg | 20Transdermal patch | 540232.22654/2.7/0232.226Approved 8 October 2024 | Registered | S6 | PIPIL |
| Sobrixa 0,4 MG EACH TABLET CONTAINS BUPRENORPHINE HYDROCHLORIDE EQUIVALENT TO BUPRENORPHINE 0,4 mg | 0,4 mg | 60035160/34/0351 | Registered | S6 | None |
| Sobrixa 2,0 MG EACH TABLET CONTAINS BUPRENORPHINE HYDROCHLORIDE EQUIVALENT TO BUPRENORPHINE 2,0 mg | 2,0 mg | 600352600/34/0352 | Registered | S6 | None |
| Sobrixa 8,0 MG EACH TABLET CONTAINS BUPRENORPHINE HYDROCHLORIDE EQUIVALENT TO BUPRENORPHINE 8,0 mg | 8,0 mg | 60035360/34/0353 | Registered | S6 | None |
| Temgesic 1 ML EACH 1,0 ml SOLUTION CONTAINS BUPRENORPHINE HYDROCHLORIDE EQUIVALENT TO BUPRENORPHINE 0,3 mg | 1 ml | L0157L/2.9/157 | Registered | S6 | None |
| Temgesic 2 ML EACH 1,0 ml SOLUTION CONTAINS BUPRENORPHINE HYDROCHLORIDE EQUIVALENT TO BUPRENORPHINE 0,3 mg | 2 ml | L0158L/2.9/0158 | Registered | S6 | None |
| Temgesic sublingual tablets EACH TABLET CONTAINS BUPRENORPHINE HYDROCHLORIDE EQUIVALENT TO BUPRENORPHINE 0,2 mg | Tablets | S0327S/2.7/327 | Registered | S6 | None |
Regulatory status
Where S6 sits on the scale
Prescription-only, no repeats without a new prescription.
Schedule 6 covers the most tightly controlled ordinary prescription medicines. Every dispensing needs its own new prescription; nothing can be repeated on the same script. When prescribed, the quantity must be written out in both figures and words. Its price, name, pack size and strength can still be told to the public, as long as nothing links it to what it treats.
Schedule S6, matched to the Consolidated Schedules by ingredient, confidence high.
Who may supply: A pharmacist dispensing against a written or verbal prescription from an authorised prescriber; a veterinarian, who may also prescribe, compound or dispense it directly; a medical practitioner or dentist, who may prescribe it and may compound or dispense it directly only if licensed under section 22C(1)(a); manufacturers and wholesalers may supply people who may lawfully possess it.
Consolidated Schedules listings for Buprenorphine hydrochloride equivalent to buprenorphine
S6: Buprenorphine
Consolidated Schedules 06 July 2026, line 10099
Pharmacological class: Complementary Medicines: Health Supplements (class 34)
This is an informational summary of the Medicines and Related Substances Act 101 of 1965 and its 2017 General Regulations. It is not medical advice and not legal advice. Always check the medicine's label, which carries the schedule number inside a square border, or ask a pharmacist if you are unsure.
SAHPRA documents
Schedule Verification
Sovetrin 5, Trinity Pharma (Pty) Ltd is scheduled S6 in its official SAHPRA documents, read with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.