NEWS FROM USA
NEW PC (PATENT CHALLENGE) EXCLUSIVITY LISTING IN THE ORANGE BOOK
|
DRUG |
COMPANY |
Corresponding RLD |
PC exclusivity expiration date |
Other TA holders |
|
Clindamycin phosphate (1.2%) and benzoyl peroxide (2.5%) Gel |
Actavis |
Acanya (Dow) |
Tolmar |
|
|
Minocycline hydrochloride 55mg ER tablets |
Lupin |
Solodyn (Medicis) |
Aurobindo, Mylan, Sun, Zydus, Sandoz |
|
|
Ranolazine ER tablets |
Lupin |
Ranexa (Gilead) |
Teva, Ajanta, Auribindo, Cipla, Actavis |
NEW CGT (COMPETITIVE GENERIC THERAPY) EXCLUSIVITY LISTING IN THE ORANGE BOOK
|
DRUG |
COMPANY |
Corresponding RLD |
CGT exclusivity expiration date |
|
Pyridostigmine syrup |
Novitium |
Mestinon (Bausch) |
NEW GENERICS LAUNCHES IN THE US DURING LAST WEEK
|
DRUG |
COMPANY |
Corresponding RLD |
Annual sales quoted in press release as per IQVIA |
Press Release |
|
Busulfan injection |
SunGen/Athenex |
Busulfex (Otsuka) |
$33.6 Mn |
|
|
Cinacalcet tablets |
Piramal |
Sensipar (Amgen) |
N/A |
USFDA Inspections
Lupin (Somerset facility): U.S. FDA classifies the inspection of Lupin's Somerset (NJ, US) facility as OAI.
NEWS FROM EUROPE
UK SPC (SUPPLEMENTARY PROTECTION CERTIFICATE) UPATE
|
PRODUCT |
PATENT No. |
ACTION RELATED TO SPC |
SPC Expiry |
Link |
|
Fosaprepitant |
EP0748320 B1 |
Pediatric extension granted on SPC |
27 Aug. 2020 (inclusive PED extension) |
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