exclusivity

FDA Goes Farther Down the 3-Year Exclusivity Rabbit Hole With XTAMPZA ER-ROXYBOND Exclusivity Decision
FDA Goes Farther Down the 3-Year Exclusivity Rabbit Hole With XTAMPZA ER-ROXYBOND Exclusivity Decision
FDA Law Blog
FDA
Xtampza ER
Hatch Waxman Act
exclusivity
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With patent loss looming, Takeda knocks proposed Velcade copycats in FDA petition
With patent loss looming, Takeda knocks proposed Velcade copycats in FDA petition
Fierce Pharma
patents
Takeda
Velcade
FDA
exclusivity
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Examining the “Drug Innovation Paradox”: Should the Length of Exclusivity Reflect the Time it Takes to Develop a Drug?
Examining the “Drug Innovation Paradox”: Should the Length of Exclusivity Reflect the Time it Takes to Develop a Drug?
FDA Law Blog
FDA
innovation
exclusivity
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FDA’s Ruling on Generic ZITHROMAX 180-Day Exclusivity: A Little Something for Everyone!
FDA’s Ruling on Generic ZITHROMAX 180-Day Exclusivity: A Little Something for Everyone!
FDA Law Blog
FDA
generics
Zithromax
exclusivity
Pfizer
Lupin
antibiotics
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Is a Challenge to FDA’s “Route-of-Abuse” 3-Year Exclusivity Approach to Abuse-Deterrent Drug Products on the Horizon?
Is a Challenge to FDA’s “Route-of-Abuse” 3-Year Exclusivity Approach to Abuse-Deterrent Drug Products on the Horizon?
FDA Law Blog
FDA
exclusivity
off-label
Egalet
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The Improving Access to Affordable Prescription Drugs Act: A Different Tack on Exclusivity
The Improving Access to Affordable Prescription Drugs Act: A Different Tack on Exclusivity
FDA Law Blog
Affordable Prescription Drugs Act
exclusivity
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FDA Sued Over 180-Day Exclusivity Determination for Generic NAMENDA XR; It’s All About the “Causal Connection”
FDA Sued Over 180-Day Exclusivity Determination for Generic NAMENDA XR; It’s All About the “Causal Connection”
FDA Law Blog
FDA
Namenda XR
generica
Amneal
exclusivity
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AZ nabs 6 more months of Symbicort exclusivity—and the sales that come with it
AZ nabs 6 more months of Symbicort exclusivity—and the sales that come with it
Fierce Pharma
AstraZeneca
Symbicort
exclusivity
pediatrics
asthma
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FDA Prevails in Otsuka Challenge to Scope of ABILIFY 3-Year Exclusivity, Leaving Intact ARISTADA 505(b)(2) NDA Approval
FDA Prevails in Otsuka Challenge to Scope of ABILIFY 3-Year Exclusivity, Leaving Intact ARISTADA 505(b)(2) NDA Approval
FDA Law Blog
FDA
Otsuka
Abilify
exclusivity
Aristada
Alkermes
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Sandoz asks Supreme Court to nix 'exclusivity windfall' delaying biosimilar launches
Sandoz asks Supreme Court to nix 'exclusivity windfall' delaying biosimilar launches
Fierce Pharma
Sandoz
generics
Supreme Court
exclusivity
biosimilars
Zarxio
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No False Starts: FDA Prevails in Eisai Challenge Over NCE Exclusivity Start Dates for BELVIQ and FYCOMPA
No False Starts: FDA Prevails in Eisai Challenge Over NCE Exclusivity Start Dates for BELVIQ and FYCOMPA
FDA Law Blog
FDA
Eisai
exclusivity
Belviq
Fycompa
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District Court Rules for FDA in Battle Over the Scope of 3-Year Exclusivity in the Context of Dueling Tacrolimus NDAs
District Court Rules for FDA in Battle Over the Scope of 3-Year Exclusivity in the Context of Dueling Tacrolimus NDAs
FDA Law Blog
FDA
exclusivity
Astellas
Veloxis
kidney transplants
Envarsus
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Bam! Bam! Two Plaintiffs Fall in Two District Court Decisions Concerning Orphan Drug Exclusivity Carve-Outs
Bam! Bam! Two Plaintiffs Fall in Two District Court Decisions Concerning Orphan Drug Exclusivity Carve-Outs
FDA Law Blog
Otsuka
Abilify
orphan drugs
exclusivity
Fusilev
Spectrum Pharmaceuticals
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U.S. court grants exclusivity for Amarin's Vascepa
U.S. court grants exclusivity for Amarin's Vascepa
Yahoo/Reuters
Amarin
Vascepa
exclusivity
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Pfizer Revenues Hit by Lost Exclusivity in 1Q15
Pfizer Revenues Hit by Lost Exclusivity in 1Q15
Yahoo/Market Realist
Pfizer
exclusivity
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Amarin Argues In Court For Vascepa Exclusivity
Amarin Argues In Court For Vascepa Exclusivity
Seeking Alpha
Amarin
Vascepa
exclusivity
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Protecting Patent Exclusivity: House Passes Bill to Ensure that Drug Scheduling Does Not Adversely Effect Marketing of NCEs
Protecting Patent Exclusivity: House Passes Bill to Ensure that Drug Scheduling Does Not Adversely Effect Marketing of NCEs
FDA Law Blog
patents
FDA
exclusivity
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US FDA tweaks requirements for 12-year biologics exclusivity
US FDA tweaks requirements for 12-year biologics exclusivity
Biopharma-Reporter
FDA
exclusivity
biologics
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Amarin Sues FDA Over Exclusivity for Fish Oil Pill
Amarin Sues FDA Over Exclusivity for Fish Oil Pill
Bloomberg
Amarin
FDA
Vascepa
exclusivity
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PLAN B Revisited: FDA Rules on One-Step Exclusivity and ANDA Labeling Carve-Outs
PLAN B Revisited: FDA Rules on One-Step Exclusivity and ANDA Labeling Carve-Outs
FDA Law Blog
FDA
exclusivity
ANDAs
Plan B contraceptive
Teva Pharmaceuticals
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