Licensing opportunities
AVAILABLE DOSSIERS AND MAs
GENERIC NAME (click to open) | PHARMACEUTICAL FORM & STRENGTH | PHARMACOTHERAPEUTIC GROUP | TYPE OF APPLICATION | MAs AVAILABLE IN |
tablets 0.25 mg; 0.5 mg; 1 mg | anxiolytic | generic | HU | |
film-coated tablets 5 mg/10 mg; 10 mg/10 mg | antihypertensive/ hypolipidemic | generic | RO | |
chewable tablets 680 mg/80 mg | antacid | hybrid | BE, CZ, DE, HU, PT, SK, UK | |
film-coated tablets 10 mg; 20 mg; 40 mg; 80 mg | hypolipidemic | generic | PL, RO, SK, UK | |
film-coated tablets 2.5 mg film-coated tablets 5 mg; 10 mg | antihypertensive/ antianginal/medicine for treatment of heart failure | generic | RO, SK HU, RO, SK | |
capsules, hard 375 mg | mucolytic | generic | N/A | |
capsules,hard 500 mg | antibiotic | generic | PL | |
film-coated tablets 400 mg | antibiotic | generic | CZ*, DE*, PL*, PT, UK | |
film-coated tablets 500 mg/30 mg/15 mg/60 mg | analgesic/ antipyretic/ decongestant/ vitamin C | bibliographic | N/A | |
tablets 50 mg; 100 mg | antiarrhythmic | generic | NL | |
film-coated tablets 342 mg | analgesic/antipyretic | generic | NL, PL, SK, UK | |
film-coated tablets 684 mg | analgesic/antipyretic | generic | CZ, PL, SK, UK | |
film-coated tablets 200 mg/500 mg | analgesic/antipyretic | generic | DK, EL, HU, MT | |
tablets 10 mg/5 mg; 20 mg/5 mg; 20 mg/10 mg | antihypertensive | generic | MT | |
LISINOPRIL/ HYDROCHLOROTHIAZIDE | tablets 20 mg/12.5 mg | antihypertensive | generic § | CZ, HU, PL, RO |
film-coated tablets 500 mg; 850 mg; 1000 mg | antidiabetic | generic | N/A | |
film-coated tablets 400 mg | antibiotic | generic | PL | |
film-coated tablets 5 mg; 10 mg; 20 mg; 40 mg | hypolipidemic | generic | DK, HU, UK | |
film-coated tablets 25 mg; 50 mg; 100 mg | antidiabetic (DPP-4 inhibitor) | generic | HU*, RO* | |
film-coated tablets 5 mg; 10 mg | hypnotic/sedative | generic § | RO, UK |
GENERIC NAME | PHARMACEUTICAL FORM & STRENGTH | PHARMACOTHERAPEUTIC GROUP | TYPE OF APPLICATION | MAs AVAILABLE IN |
granules for oral suspension 250 mg/5 ml | antibiotic | generic | PL | |
granules for oral suspension 100 mg/5 ml | antibiotic | generic | CZ*, HU, PL*, PT | |
oral suspension 100 mg/5 ml | analgesic/antipyretic | generic | UK, PL | |
oral suspension 200 mg/5 ml | analgesic/antipyretic | generic | CZ, PL | |
oral solution 5 mg/ml | substitute for opioid dependence | generic | AT, DE, HU, IT, PL, RO | |
concentrate for oral solution 10 mg/ml | substitute for opioid dependence | bibliographic | AT, CZ, DE, PT, RO, SK, UK | |
oral solution 1 mg/ml | substitute for opioid dependence | bibliographic | IE, MT, PL, UK |
GENERIC NAME | PHARMACEUTICAL FORM & STRENGTH | PHARMACOTHERAPEUTIC GROUP | TYPE OF APPLICATION | MAs AVAILABLE IN |
gel 1.16 %; 2.32 % | analgesic for topical use | hybird | CZ*, EL*, PL*, RO*, SK* | |
gel 0.1 % | antipruritic/antihistamine for topical use | hybrid | DE*, IT*, RO* | |
gel 50 mg/g | analgesic for topical use | hybrid | CZ, DE, HU, IT*, PL, PT, RO, SK |
ON-GOING DEVELOPMENTS
GENERIC NAME | PHARMACEUTICAL FORM & STRENGTH | PHARMACOTHERAPEUTIC GROUP | TYPE OF APPLICATION | DEVELOPMENT TIMELINE |
DAPAGLIFLOZIN | film-coated tablets 5 mg; 10 mg | antidiabetic | generic | In early development |
capsules, hard 305 mg | iron preparations | generic | In development | |
film-coated tablets 500 mg | analgesic/antipyretic | generic | Q2 2025 | |
prolonged-release tablets 500 mg; 750 mg; 1000 mg | antidiabetic | generic | In development | |
film-coated tablets 2.5 mg; 5 mg; 10 mg | angiotensin-converting enzyme (ACE) inhibitor | generic | In early development | |
tablets 1.25 mg; 2.5 mg; 5 mg; 10 mg | antihypertensive | generic | Q3 2026 | |
film-coated tablets 50 mg/1000 mg; 50 mg/850 mg | antidiabetic | generic | Q4 2025 | |
orodispersible tablets 5 mg; 10 mg; 20 mg | erectile dysfunction | generic | In development |
GENERIC NAME | PHARMACEUTICAL FORM & STRENGTH | PHARMACOTHERAPEUTIC GROUP | TYPE OF APPLICATION | DEVELOPMENT TIMELINE |
cream 10 mg/g | antifungals for topical use | bibliographic | Q3 2025 | |
ointment 20 mg/g | antibiotic for topical use | hybrid | Q4 2024 |
§The Bioequivalence study is not according to Guideline on bioanalytical method validation,
2012EMEA/CHMP/EWP/192217/2009 Rev. 1 Corr. 2
* On-going DCP/Pending MAs
September, 2024
Business development contact info:
+ 389 2 3110 745, + 389 2 3110 749
business.development@alkaloid.com.mk
www.alkaloid.com.mk
