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The Public Health Agency of Sweden

Priority list of off-patent antibiotic products at risk for lack of availability in Sweden

In order to identify antibiotic products that are particularly valuable for the Swedish healthcare, the Public Health Authority, in collaboration with PLATINEA and an external reference group, has carried out a clinical evaluation of antibiotic products based on their substance, formulation and strength.

The Public Health Agency has published a new priority list within the framework of the government's mission To strengthen access to off-patent antibiotics, in collaboration with PLATINEA and an advisory reference group. In contrast to previous corresponding priority lists from 2017 and 2021, antibiotic products that are not marketed in Sweden but are often prescribed under license, or are widely used in Europe have also been valued and prioritized.

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The analysis includes all drugs (ATC codes) that contain an antibacterial substance and are used to treat or prevent bacterial infection, including systemic (infusion fluids and oral) and topical drugs (ointments, creams, gels, drops, vaginal, suppositories and oral non-absorbable).

Selection criteria used to identify antibiotic products for the clinical evaluation

Off-patent antibiotic products marketed in Sweden 2021:

  • Total sales in 2021: ≤ SEK 3,000,000, or
  • Repeated shortage situations (2017–2021; only non-exchangeable, no parallel imports):, concluded as well as ongoing, for at least 60 days in total

Antibiotic products not marketed in Sweden in 2021:

  • All deregistered in 2020–2021
  • Prescribed on license: ≥ 30 times in 2021

The experts in the reference group scored all products on a scale of 0–2. The individual scores were compiled and categorized by the Public Health Authority. Categories A–C mean the following valuation:

  • A. Very valuable to have access to in Sweden. Considerable clinical consequences if the product is not available.
  • B. Valuable to have access to in Sweden. Clinical and/or logistical (resource-wise) consequences if the product is not available.
  • C. There is usually a relatively equal alternative.

A total of 128 antibiotic products were assessed, of which 108 are marketed in Sweden. Of 32 marketed products in category A, 22 were not interchangeable according to the Medical Product Agency's definition. Twenty-one products are on the priority list, due to repeated shortages, regardless of sales value. Of these, three were categorized as A. Twenty products that are not marketed in Sweden, of which six due to extensive use in Europe, were evaluated clinically.

The evaluation showed, among other things, that preparation forms adapted to children were highly prioritized.

Table 1. Marketed antibiotic products with relatively low sales and/or repeated shortage situations 2017–2021, classified as category A, B or C in the clinical evaluation.
ATC Substance Formulation Strength Category
J01GB03 Gentamicin Intravenous 40 mg/ml A
J01XB01 Colistin Intravenous 1 million IE A
J01DD02 Ceftazidime Intravenous 2 g A
P01AB01 Metronidazole Oral suspension 40 mg/ml A
J01CR02 Amoxicillin-clavulanic acid Tablets/Capsules 500 mg/125 mg A
J01DB05 Cefadroxil Oral suspension 100 mg/ml A
J04AB02 Rifampicin Oral suspension 20 mg/ml A
J01CA04 Amoxicillin Oral suspension 100 mg/ml A
J01EE01 Trimethoprim-sulfametoxazol Oral suspension 40 mg/ml + 8 mg/ml A
J01CF05 Flucloxacillin Oral suspension 50 mg/ml A
J01CE02 Phenoxymethylpenicillin Tablets/Capsules 250 mg A
J01CA01 Ampicillin Intravenous 2 g A
J01XA01 Vancomycin Intravenous 500 mg A
J01CF05 Flucloxacillin Tablets/Capsules 125 mg A
J01MA02 Ciprofloxacin Oral suspension 100 mg/ml A
J01CF02 Cloxacillin Intravenous 1 g A
J01GB06 Amikacin Intravenous 250 mg/ml A
J01MA02 Ciprofloxacin Intravenous 2 mg/ml A
J01CA04 Amoxicillin Tablets/Capsules 500 mg A
J01EA01 Trimethoprim Oral suspension 10 mg/ml A
J01FA01 Erythromycin Oral suspension 100 mg/ml A
J01FF01 Clindamycin Oral suspension 15 mg/ml A
J04AB04 Rifabutin Tablets/Capsules 150 mg A
J01FA10 Azithromycin Tablets/Capsules 250 mg A
J01CE02 Phenoxymethylpenicillin Oral suspension 50 mg/ml A
J01XX08 Linezolid Oral suspension 20 mg/ml A
G01AA10 Clindamycin Vaginal 100 mg A
D06AX09 Mupirocin Ointment 2% A
J01CR02 Amoxicillin-clavulanic acid Oral suspension 50 mg/ml + 13 mg/ml A
J01EA01 Trimethoprim Tablets/Capsules 160 mg A
J01CA04 Amoxicillin Oral suspension 50 mg/ml A
J01EE01 Trimethoprim-sulfametoxazol Tablets/Capsules 800 mg/160 mg A
J01CE02 Phenoxymethylpenicillin Tablets/Capsules 500 mg B
J01EA01 Trimethoprim Tablets/Capsules 100 mg B
J01DD02 Ceftazidime Intravenous 1 g B
J01DD02 Ceftazidime Intravenous 500 mg B
J01FF01 Clindamycin Intravenous 600 mg B
J01FA10 Azitromycin Oral suspension 40 mg/ml B
J01CE02 Phenoxymethylpenicillin Oral suspension 250 mg/ml B
G01AF01 Metronidazole Vaginal 500 mg B
J01CA01 Ampicillin Intravenous 1 g B
J01CA08 Pivmecillinam Tablets/Capsules 400 mg B
J01CA04 Amoxicillin Tablets/Capsules 750 mg B
J01MA14 Moxifloxacin Tablets/Capsules 400 mg B
P01AB01 Metronidazole Tablets/Capsules 200 mg B
J01FA01 Erythromycin Tablets/Capsules 250 mg B
J01XE01 Nitrofurantoin Tablets/Capsules 5 mg B
S01AA01 Chloramphenicol Eye ointment/-gel 10 mg/g B
J04AB02 Rifampicin Tablets/Capsules 150 mg B
J01EE01 Trimethoprim-sulfametoxazol Tablets/Capsules 400 mg/80 mg B
J01CR02 Amoxicillin-clavulanic acid Tablets/Capsules 875 mg/125 mg B
J01CR05 Piperacillin-tazobactam Intravenous 2 g/0,25 g B
J01GB01 Tobramycin Inhalation 300 mg/5 ml B
J01DB05 Cefadroxil Tablets/Capsules 500 mg B
J01FF01 Clindamycin Tablets/Capsules 150 mg B
G01AA10 Clindamycin Vaginal creme 2% B
J01FA10 Azithromycin Tablets/Capsules 500 mg B
D06AX01 Fucidin Ointment 2 % B
S02CA05 Fluocinolonacetonid and antiinfectives Ear drops 3 mg/ml + 0,25 mg/ml B
J01CA04 Amoxicillin Tablets/Capsules 1 g B
J01CA04 Amoxicillin Tablets/Capsules 375 mg B
J01FA01 Erythromycin Tablets/Capsules 500 mg B
J01MA12 Levofloxacin Tablets/Capsules 500 mg B
J04AB02 Rifampicin Intravenous 600 mg B
S01AA01 Chloramphenicol Eye drops 5 mg/ml B
S02AA15 Ciprofloxacin Eye drops 2 mg/ml B
S02AA15 Ciprofloxacin Eye drops 3 mg/ml B
S02CA02 Flumetason and antiinfectives Eye drops 0.2% + 1% B
J01MA02 Ciprofloxacin Tablets/Capsules 750 mg B
J01MA12 Levofloxacin Tablets/Capsules 250 mg B
J01CR02 Amoxicillin-clavulanic acid Oral suspension 80 mg/ml + 12 mg/ml B
J01XA02 Teikoplanin Intravenous 400 mg B
P01AB01 Metronidazole Tablets/Capsules 500 mg B
J01AA02 Doxycycline Oral suspension 10 mg/ml B
J04AM02 Rifampicin och isoniazid Tablets/Capsules 150 mg/75 mg B
J04AM06 Rifampicin, pyrazinamide, ethambutol and isoniazid Tablets/Capsules 150 mg/75 mg/400 mg/275 mg B
J01MA02 Ciprofloxacin Oral suspension 50 mg/ml B
J01AA02 Doxycycline Tablets/Capsules 40 mg B
D10AF01 Clindamycin Cutaneous emulsion 10 mg/ml B
J01MA02 Ciprofloxacin Tablets/Capsules 250 mg B
J01MA12 Levofloxacin Inhalation 240 mg C
J01XB01 Colistin Inhalation 2 million IE C
J01FA01 Erythromycin Oral suspension 200 mg/ml C
J01FA10 Azithromycin Intravenous 500 mg C
J01XX01 Fosfomycin Intravenous 40 mg/ml C
J01MA14 Moxifloxacin Intravenous 400 mg/250 ml C
S01AA26 Azithromycin Eye drops 15 mg/g C
G01AF01 Metronidazole Vaginal gel 7,5 mg/g C
J01AA12 Tigecycline Intravenous 50mg C
J01MA12 Levofloxacin Intravenous 5 mg/ml C
P01AB02 Tinidazole Tablets/Capsules 500 mg C
J01DC02 Cefuroxime Intravenous 1500 mg C
D10AF51 Clindamycin Gel 50mg/g + 10mg/g C
J01XA02 Teikoplanin Intravenous 200 mg C
J01FA09 Clarithromycin Tablets/Capsules 500 mg C
A07AA09 Vancomycin Tablets/Capsules 250 mg C
J01FA09 Clarithromycin Tablets/Capsules 250 mg C
S01CA01 Tobramycin + dexamethasone, Eye drops 3 mg/ml / 1 mg/ml C
J01DF01 Aztreonam Inhalation 75 mg C
J01DC02 Cefuroxime Intravenous 750 mg C
J01AA07 Tetracycline Tablets/Capsules 250 mg C
J01AA02 Doxycycline Intravenous 20 mg/ml C
J01DC02 Cefuroxime Intravenous 250 mg C
J01DF01 Aztreonam Intravenous C
J01DB04 Cefazolin Intravenous 2 g C
S01AA12 Tobramycin Eye drops 3 mg/ml C
S01AA27 Cefuroxime Intravenous 50 mg C

J01GB01 (fass.se) (in Swedish)

Table 2. Antibiotic products recently deregistered or with frequent license prescription in Sweden 2021, classified as category A, B or C in the clinical evaluation.
ATC Substance Formulation Strength Category
J04AK02 Ethambutol Tablets/Capsules 400 mg A
J01DD14 Ceftibuten Oral suspension 36 mg/ml A
J01DD14 Ceftibuten Tablets/Capsules 400 mg A
J01DD08 Cefixime Oral suspension 100 mg/5 ml A
J01DD08 Cefixime Tablets/Capsules 400 mg A
J01GB01 Tobramycin Intravenous 10 mg/ml B
J01DB05 Cefadroxil Tablets/Capsules 1 g B
J01CE01 Bensatin bensylpenicillin Intravenous 300000 E/ml B
J01XX01 Fosfomycin Oral suspension 3 g B
J01FA09 Clarithromycin Oral suspension 25 mg/ml B
J01XC01 Fucidinsyra Tablets/Capsules 250 mg C
J01FG01 Pristinamycin Tablets/Capsules 500 mg C
J01FA01 Erythromycin Enterocapsules 250 mg C
J01MA06 Norfloxacin Tablets/Capsules 400 mg C
Table 3. Antibiotic products that have high sales in Europe but are not marketed in Sweden and that are categorized in the clinical evaluation.
ATC Substance Formulations No of countries Clinical evaluation (0-5)
J01DC02 Cefuroxime-axetil fixed, oral suspension 17 1 
J01DD08 Cefixime& fixed, oral suspension 8 5 
J01DD13 Cefpodoxime- proxetil fast, oral suspension 21 0 
J01MA01 Ofloxacin several 13 0
J01CR01 Ampicillin-sulbactam Intravenous 4 4
J01CA17 Temocillin Intravenous 4 4

Updated:

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