Active substance
Baclofen
- SFDA 13
- US FDA 53
- Health Canada 23
- US price lines 9
- NHS prices 3
- WHO EML 1
- Safety 2
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| BACLOFEN INTRATHECAL SINTETICA 0.05MG/ML INJECTION | 0.05 mg/ml | Solution for injection · Intrathecal use | 10 Ampoule | SAR 274.90 | NCE · Prescription | Sintetica SA | Valid |
| BACLOFEN INTRATHECAL SINTETICA 0.5MG/ML INJECTION | 0.5 mg/ml | Solution for injection · Intrathecal use | 5 Ampoule | SAR 1374.45 | NCE · Prescription | Sintetica SA | Valid |
| BACLOFEN INTRATHECAL SINTETICA 2MG/ML INJECTION | 2 mg/ml | Solution for injection · Intrathecal use | 10 Ampoule | SAR 2748.90 | NCE · Prescription | Sintetica SA | Valid |
| BACLOFEN INTRATHECAL SINTETICA 2MG/ML INJECTION | 2 mg/ml | Solution for injection · Intrathecal use | 1 Ampoule | SAR 1099.55 | NCE · Prescription | Sintetica SA | Valid |
| Baclofen | 1 mg/ml | Oral solution · Oral use | 1 Bottle | SAR 62.90 | Generic · Prescription | Waymade Plc UK | Valid |
| Baclon | 10 mg | Tablet · Oral use | 50 Blister | SAR 31.40 | Generic · Prescription | Alrai Pharmaceutical industry Co. (L.L.C) | Valid |
| Baclon | 25 mg | Tablet · Oral use | 50 Blister | SAR 63.45 | Generic · Prescription | Alrai Pharmaceutical industry Co. (L.L.C) | Valid |
| Bastix | 10 mg | Tablet · Oral use | 50 Blister | SAR 26.95 | Generic · Prescription | Labatec- Pharma S.A | Valid |
| Bastix | 25 mg | Tablet · Oral use | 50 Blister | SAR 54.40 | Generic · Prescription | Labatec- Pharma S.A | Valid |
| LIORESAL 10MG TAB | 10 mg | Tablet · Oral use | 50 Blister | SAR 33.70 | NCE · Prescription | NOVARTIS | Valid |
| LIORESAL 25MG TAB | 25 mg | Tablet · Oral use | 50 Blister | SAR 61.15 | NCE · Prescription | NOVARTIS | Valid |
| Loanta | 10 mg | Tablet · Oral use | 50 Blister | SAR 29.20 | Generic · Prescription | ALPHA PHARMA INDUSTRY | Valid |
| baclocan | 10 mg | Tablet · Oral use | 100 Bottle | SAR 53.90 | Generic · Prescription | Pharma Pharmaceutical Industries (PPI) | Valid |
Indications — CHI Daman Drug Formulary
METACHROMATIC LEUKODYSTROPHY; MULTIPLE SCLEROSIS; SPASTICITY
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| BACLOFEN | 10MG | tablet · oral | IVAX SUB TEVA PHARMS | Prescription | 21 Jul 1988 |
| BACLOFEN | 20MG | tablet · oral | IVAX SUB TEVA PHARMS | Prescription | 21 Jul 1988 |
| LIORESAL | 0.5MG/ML; 2MG/ML; 0.05MG/ML | injectable · intrathecal | AMNEAL | Prescription | 17 Jun 1992 |
| BACLOFEN | 10MG; 20MG | tablet · oral | YILING | Prescription | 19 Aug 1996 |
| BACLOFEN | 20MG | tablet · oral | PHARMOBEDIENT | Prescription | 29 Jul 2005 |
| BACLOFEN | 20MG; 10MG | tablet · oral | PH HEALTH | Prescription | 30 Aug 2005 |
| BACLOFEN | 20MG; 10MG; 5MG | tablet · oral | LANNETT CO INC | Prescription | 20 Dec 2005 |
| BACLOFEN | 10MG | tablet · oral | Prescription | 31 Oct 2007 | |
| BACLOFEN | 20MG; 10MG | tablet · oral | TP ANDA HOLDINGS | Prescription | 31 Oct 2007 |
| BACLOFEN | 20MG; 10MG | tablet · oral | NORTHSTAR HLTHCARE | Prescription | 18 Sep 2009 |
| BACLOFEN | 10MG | tablet · oral | NORTHSTAR HLTHCARE | Prescription | 18 Sep 2009 |
| BACLOFEN | 5MG | tablet · oral | SOMERSET THERAPS LLC | Prescription | 18 Feb 2010 |
| GABLOFEN | 0.05MG/ML; 0.5MG/ML; 2MG/ML; 1MG/ML | injectable · intrathecal | PIRAMAL CRITICAL | Prescription | 19 Nov 2010 |
| BACLOFEN | 0.05MG/ML; 0.5MG/ML; 2MG/ML | injectable · intrathecal | AMNEAL | Prescription | 3 May 2016 |
| BACLOFEN | 5MG; 10MG; 20MG; 15MG | tablet · oral | RUBICON RESEARCH | Prescription | 28 Nov 2017 |
| BACLOFEN | 10MG; 20MG; 5MG; 15MG | tablet · oral | ZYDUS LIFESCIENCES | Prescription | 23 Nov 2018 |
| BACLOFEN | 10MG; 20MG; 5MG | tablet · oral | ADAPTIS | Prescription | 1 Feb 2019 |
| BACLOFEN | 1MG/ML | injectable · intrathecal | MAIA PHARMS INC | Prescription | 30 Jul 2019 |
| BACLOFEN | 0.5MG/ML; 2MG/ML; 0.05MG/ML | injectable · intrathecal | MAIA PHARMS INC | Prescription | 11 Sep 2019 |
| OZOBAX DS | 10MG/5ML | solution · oral | ROSEMONT PHARMACEUTICALS LLC | Prescription | 18 Sep 2019 |
| BACLOFEN | 10MG; 20MG; 5MG | tablet · oral | UNICHEM | Prescription | 9 Jul 2020 |
| BACLOFEN | 10MG; 20MG; 5MG | tablet · oral | ANDAS 5 HOLDING | Prescription | 9 Oct 2020 |
| BACLOFEN | 5MG; 10MG; 20MG | tablet · oral | RISING | Prescription | 5 Mar 2021 |
| BACLOFEN | 10MG; 20MG; 5MG | tablet · oral | AUROBINDO PHARMA LTD | Prescription | 13 Jul 2021 |
| BACLOFEN | 10MG; 20MG; 5MG | tablet · oral | REGCON HOLDINGS | Prescription | 16 Jul 2021 |
28 more — full table
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| APO-BACLOFEN | 02139332 | 10 MG | TABLET · ORAL | APOTEX INC |
| APO-BACLOFEN | 02139391 | 20 MG | TABLET · ORAL | APOTEX INC |
| BACLOFEN | 02287021 | 10 MG | TABLET · ORAL | SANIS HEALTH INC |
| BACLOFEN | 02287048 | 20 MG | TABLET · ORAL | SANIS HEALTH INC |
| BACLOFEN | 02544660 | 10 MG | TABLET · ORAL | SIVEM PHARMACEUTICALS ULC |
| BACLOFEN | 02544679 | 20 MG | TABLET · ORAL | SIVEM PHARMACEUTICALS ULC |
| BACLOFEN INJECTION | 02413620 | 0.05 MG / 1 ML | SOLUTION · INTRATHECAL | STERIMAX INC |
| BACLOFEN INJECTION | 02413639 | 10 MG / 20 ML | SOLUTION · INTRATHECAL | STERIMAX INC |
| BACLOFEN INJECTION | 02413647 | 10 MG / 5 ML | SOLUTION · INTRATHECAL | STERIMAX INC |
| BACLOFEN INJECTION | 02457075 | 2 MG / ML | SOLUTION · INTRATHECAL | HIKMA CANADA LIMITED |
| BACLOFEN INJECTION USP | 02553341 | 2 MG / ML | SOLUTION · INTRATHECAL | JAMP PHARMA CORPORATION |
| BACLOFEN INTRATHECAL | 02485508 | 0.5 MG / ML | SOLUTION · INTRATHECAL | AVIR PHARMA INC. |
| BACLOFEN INTRATHECAL | 02485516 | 2 MG / ML | SOLUTION · INTRATHECAL | AVIR PHARMA INC. |
| JAMP BACLOFEN | 02544482 | 10 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| JAMP BACLOFEN | 02544490 | 20 MG | TABLET · ORAL | JAMP PHARMA CORPORATION |
| MYLAN-BACLOFEN | 02088398 | 10 MG | TABLET · ORAL | MYLAN PHARMACEUTICALS ULC |
| MYLAN-BACLOFEN | 02088401 | 20 MG | TABLET · ORAL | MYLAN PHARMACEUTICALS ULC |
| PMS-BACLOFEN | 02063735 | 10 MG | TABLET · ORAL | PHARMASCIENCE INC |
| PMS-BACLOFEN | 02063743 | 20 MG | TABLET · ORAL | PHARMASCIENCE INC |
| PRO-BACLOFEN | 02152584 | 10 MG | TABLET · ORAL | PRO DOC LIMITEE |
| PRO-BACLOFEN | 02152592 | 20 MG | TABLET · ORAL | PRO DOC LIMITEE |
| RIVA-BACLOFEN | 02242150 | 10 MG | TABLET · ORAL | LABORATOIRE RIVA INC. |
| RIVA-BACLOFEN | 02242151 | 20 MG | TABLET · ORAL | LABORATOIRE RIVA INC. |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | BACLOFEN 10 MG TABLET | $0.03199 | per EA | 23 Sep 2026 |
| US NADAC | BACLOFEN 10 MG/5 ML SOLUTION | $2.04441 | per ML | 23 Sep 2026 |
| US NADAC | BACLOFEN 15 MG TABLET | $1.66662 | per EA | 23 Sep 2026 |
| US NADAC | BACLOFEN 20 MG TABLET | $0.05185 | per EA | 23 Sep 2026 |
| US NADAC | BACLOFEN 25 MG/5 ML SUSPENSION | $3.76436 | per ML | 23 Sep 2026 |
| US NADAC | BACLOFEN 25 MG/5 ML SUSPENSION | $3.78853 | per ML | 23 Sep 2026 |
| US NADAC | BACLOFEN 5 MG TABLET | $0.06798 | per EA | 23 Sep 2026 |
| US NADAC | BACLOFEN 5 MG/5 ML SOLUTION | $1.07017 | per ML | 23 Sep 2026 |
| US NADAC | FLEQSUVY 25 MG/5 ML SUSPENSION | $5.98153 | per ML | 23 Sep 2026 |
| NHS Drug Tariff | Baclofen 10mg tablets | £1.41 | 84 tablet | 1 Oct 2026 |
| NHS Drug Tariff | Baclofen 10mg/5ml oral solution sugar free | £14.95 | 150 ml | 1 Oct 2026 |
| NHS Drug Tariff | Baclofen 5mg/5ml oral solution sugar free | £3.49 | 300 ml | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
WHO WHO Model List of Essential Medicines (2025)
- 5.1.4. Medicines for cerebral palsy · complementary
Spastic cerebral palsy
Oral > Liquid: 10 mg per 5 mL | Parenteral > Locoregional injections > Intrathecal: 500 µg per mL in ampoule | Oral > Solid > tablet: 10 mg
Safety signals and safety-related labeling changes
- US FDA 19 Dec 2019 GABLOFEN — safety-related labeling change
Labeling sections changed: Use in Specific Populations - US FDA 16 Jan 2019 LIORESAL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.