exclusivity

Takeda Lowers Profit Outlook Amid Vyvanse Loss of Exclusivity, Eyes $900M Restructuring in 2024
BioSpace
Thu, 05/9/24 - 11:38 am
Takeda
Vyvanse
exclusivity
FDA restores orphan-exclusivity system after 18-month stall in wake of legal feud
Medical Marketing and Media
Tue, 01/31/23 - 11:25 pm
FDA
orphan drugs
exclusivity
Researchers Estimate Costs of Exclusivity Extensions to Encourage Antibiotic Development
RAPS.org
Mon, 10/21/19 - 06:04 pm
legistlation
regulatory
exclusivity
antibiotics
Canada agrees to 10 years exclusivity for biologics
BioCentury
Mon, 10/1/18 - 10:38 pm
Canada
biologics
exclusivity
NAFTA
[sponsored] Orange Book Companion® Adds New Features and Capabilities
CP Wire
Wed, 09/5/18 - 01:50 pm
patents
Hatch Waxman Act
FDA
exclusivity
[sponsored] Orange Book Companion® Adds New Features and Capabilities
Wed, 09/5/18 - 01:40 pm
patents
Hatch Waxman Act
FDA
exclusivity
MS patent win boosts Novartis’ Gilenya, helps Celgene and maybe Biogen too
Fierce Pharma
Fri, 07/13/18 - 11:52 am
patents
Novartis
MS
Gilenya
Celgene
exclusivity
Trump pitches changes to 180-day generic exclusivity
Biopharma Dive
Tue, 02/13/18 - 10:45 pm
Donald Trump
generics
exclusivity
FDA Goes Farther Down the 3-Year Exclusivity Rabbit Hole With XTAMPZA ER-ROXYBOND Exclusivity Decision
FDA Law Blog
Wed, 08/16/17 - 10:03 am
FDA
Xtampza ER
Hatch Waxman Act
exclusivity
With patent loss looming, Takeda knocks proposed Velcade copycats in FDA petition
Fierce Pharma
Mon, 06/26/17 - 05:03 pm
patents
Takeda
Velcade
FDA
exclusivity
Examining the “Drug Innovation Paradox”: Should the Length of Exclusivity Reflect the Time it Takes to Develop a Drug?
FDA Law Blog
Wed, 05/10/17 - 09:32 am
FDA
innovation
exclusivity
FDA’s Ruling on Generic ZITHROMAX 180-Day Exclusivity: A Little Something for Everyone!
FDA Law Blog
Mon, 05/8/17 - 11:32 am
FDA
generics
Zithromax
exclusivity
Pfizer
Lupin
antibiotics
Is a Challenge to FDA’s “Route-of-Abuse” 3-Year Exclusivity Approach to Abuse-Deterrent Drug Products on the Horizon?
FDA Law Blog
Fri, 04/7/17 - 12:04 am
FDA
exclusivity
off-label
Egalet
The Improving Access to Affordable Prescription Drugs Act: A Different Tack on Exclusivity
FDA Law Blog
Thu, 04/6/17 - 09:33 am
Affordable Prescription Drugs Act
exclusivity
FDA Sued Over 180-Day Exclusivity Determination for Generic NAMENDA XR; It’s All About the “Causal Connection”
FDA Law Blog
Tue, 01/31/17 - 09:49 am
FDA
Namenda XR
generica
Amneal
exclusivity
AZ nabs 6 more months of Symbicort exclusivity—and the sales that come with it
Fierce Pharma
Fri, 01/27/17 - 09:28 am
AstraZeneca
Symbicort
exclusivity
pediatrics
asthma
FDA Prevails in Otsuka Challenge to Scope of ABILIFY 3-Year Exclusivity, Leaving Intact ARISTADA 505(b)(2) NDA Approval
FDA Law Blog
Mon, 08/1/16 - 09:36 am
FDA
Otsuka
Abilify
exclusivity
Aristada
Alkermes
Sandoz asks Supreme Court to nix 'exclusivity windfall' delaying biosimilar launches
Fierce Pharma
Sat, 02/20/16 - 09:22 am
Sandoz
generics
Supreme Court
exclusivity
biosimilars
Zarxio
No False Starts: FDA Prevails in Eisai Challenge Over NCE Exclusivity Start Dates for BELVIQ and FYCOMPA
FDA Law Blog
Thu, 10/1/15 - 09:13 am
FDA
Eisai
exclusivity
Belviq
Fycompa
District Court Rules for FDA in Battle Over the Scope of 3-Year Exclusivity in the Context of Dueling Tacrolimus NDAs
FDA Law Blog
Wed, 06/17/15 - 06:36 pm
FDA
exclusivity
Astellas
Veloxis
kidney transplants
Envarsus

Pages