NEWS FROM USA
NEW GENERICS LAUNCHES IN THE US
|
DRUG |
COMPANY |
Corresponding RLD |
Annual sales quoted in press release as per IQVIA |
Press Release |
|
Abiraterone* tablets |
Hikma |
Zytiga (Janssen) |
$1.8 Billions |
|
|
Clobazam oral suspension |
Lupin |
Onfi (Lundbeck) |
$253 Millions |
|
|
Tolterodine tartarate ER capsules |
Camber |
Detrol LA (Pharmacia) |
N/A |
*Hikma’s shared exclusivity for Abiraterone along with other first filers shall end on 29 Apr. 2019 (based on PC exclusivity listed in Amneal’s ANDA)
NEW PC (PATENT CHALLENGE) EXCLUSIVITY LISTING IN THE ORANGE BOOK
|
DRUG |
COMPANY |
Corresponding RLD |
PC exclusivity expiration date |
Other TA holders |
|
Abiraterone tablets |
Amneal |
Zytiga (Janssen) |
Glenmark & Wockhardt |
|
|
Dalfampridine ER tablets |
Accord |
Ampyra (Acorda) |
Sun, Mylan, Teva & Micro |
NEW CGT (COMPETITIVE GENERIC THERAPY) EXCLUSIVITY LISTING IN THE ORANGE BOOK
|
DRUG |
COMPANY |
Corresponding RLD |
CGT exclusivity expiration date |
|
Hydrocortisone Valerate ointment |
Glenmark |
Westcort (Sun) |
ANDA Approvals
|
Approval Date |
Drug Product |
ANDA Sponsor |
Corresponding RLD |
Number Of Other Approved Generics |
|
13 Feb 2019 |
Encube |
Synalar (Medimetriks) |
Five |
|
|
13 Feb 2019 |
Alembic |
Vigamox (Novartis) |
Five |
|
|
12 Feb 2019 |
Vistapharm |
Cellcept (Roche) |
One (Alkem) |
|
|
14 Feb 2019 |
Aurobindo |
Advil PM (Pfizer) |
Two (Strides, Bionpharma) |
Other news from the USA
USFDA issued draft guidance on competitive generic therapy (Link for the guidance copy)
USFDA Inspections
Dr. Reddy’s Laboratories (Duvvada formulation facility): USFDA lifted warning letter on Dr. Reddy’s one of the formulation manufacturing facilities.
NEWS FROM EUROPE
Pegfilgrastim biosimilar (Europe): Mundi pharma launches Pegfilgrastim biosimilar in European countries (Germany, the Netherlands and Ireland)
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