Prezista is a brand name of darunavir, approved by the FDA in the following formulation(s):
PREZISTA (darunavir ethanolate - suspension; oral)
Manufacturer: TIBOTEC
Approval date: December 16, 2011
Strength(s): EQ 100MG BASE/ML [RLD]
PREZISTA (darunavir ethanolate - tablet; oral)
Manufacturer: TIBOTEC
Approval date: February 25, 2008
Strength(s): EQ 600MG BASE [RLD]
Manufacturer: TIBOTEC
Approval date: October 21, 2008
Strength(s): EQ 400MG BASE
Manufacturer: TIBOTEC
Approval date: December 18, 2008
Strength(s): EQ 150MG BASE, EQ 75MG BASE
Has a generic version of Prezista been approved?
No. There is currently no therapeutically equivalent version of Prezista available.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Prezista. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: About generic drugs.
Related Patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
.alpha.-and .beta.-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors
Patent 5,843,946
Issued: December 1, 1998
Inventor(s): Vazquez; Michael L. & Mueller; Richard A. & Talley; John J. & Getman; Daniel & DeCrescenzo; Gary A. & Freskos; John N.
Assignee(s): G.D. Searle & Co.
.alpha.- and .beta.-amino acid hydroxyethylamino sulfonamide compounds are effective as retroviral protease inhibitors, and in particular as inhibitors of HIV protease.Patent expiration dates:
- December 1, 2015✓✓
- December 1, 2015✓✓
- December 1, 2015✓✓
- December 1, 2015✓✓
- June 1, 2016✓
- December 1, 2015
Method for improving pharmacokinetics
Patent 6,037,157
Issued: March 14, 2000
Inventor(s): Norbeck; Daniel W. & Kempf; Dale J. & Leonard; John M. & Bertz; Richard J.
Assignee(s): Abbott Laboratories
A method is disclosed for improving the pharmacokinetics of a drug which is metabolized by cytochrome P450 monooxygenase.Patent expiration dates:
- June 26, 2016✓
- June 26, 2016✓
- December 26, 2016✓
- June 26, 2016
.alpha.- and .beta.-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors
Patent 6,248,775
Issued: June 19, 2001
Inventor(s): Vazquez; Michael L. & Mueller; Richard A. & Talley; John J. & Getman; Daniel P. & DeCrescenzo; Gary A. & Freskos; John N. & Bertenshaw; Deborah E. & Heintz; Robert M.
Assignee(s): G. D. Searle & Co.
.alpha.- and .beta.-amino acid hydroxyethylamino sulfonamide compounds are effective as retroviral protease inhibitors, and in particular as inhibitors of HIV protease.Patent expiration dates:
- August 13, 2014✓
- February 13, 2015✓
- August 13, 2014
&agr;-and &bgr;-amino acid hydroxyethlamino sulfonamides useful as retroviral protease inhibitors
Patent 6,335,460
Issued: January 1, 2002
Inventor(s): Michael L.; Vazquez & Richard A.; Mueller & John J.; Talley & Daniel; Getman & Gary A.; DeCrescenzo & John N.; Freskos
Assignee(s): G.D. Searle & Co.
&agr;- and &bgr;-amino acid hydroxyethylamino sulfonamide compounds are effective as retroviral protease inhibitors, and in particular as inhibitors of HIV protease.Patent expiration dates:
- August 25, 2012✓✓✓
- August 25, 2012✓✓✓
- August 25, 2012✓✓✓
- August 25, 2012✓✓✓
- February 25, 2013✓
- August 25, 2012
Method for improving pharmacokinetics
Patent 6,703,403
Issued: March 9, 2004
Inventor(s): Daniel W.; Norbeck & Dale J.; Kempf & John M.; Leonard & Richard J.; Bertz
Assignee(s): Abbott Laboratories
A method is disclosed for improving the pharmacokinetics of a drug which is metabolized by cytochrome P450 monooxygenase.Patent expiration dates:
- June 26, 2016✓
- June 26, 2016✓
- December 26, 2016✓
- June 26, 2016
Fitness assay and associated methods
Patent 7,470,506
Issued: December 30, 2008
Inventor(s): Erickson; John W. & Gulnik; Sergei V. & Mitsuya; Hiroaki & Ghosh; Arun K.
Assignee(s): The United States of America as represented by the Department of Health and Human Services
Board of Trustees of the University of Illinois
The present invention provides an assay for determining the biochemical fitness of a biochemical species in a mutant replicating biological entity relative to its predecessor. The present invention further provides a continuous fluorogenic assay for measuring the anti-HIV protease activity of protease inhibitor. The present invention also provides a method of administering a therapeutic compound that reduces the chances of the emergence of drug resistance in therapy. The present invention also provides a compound of formula (I) or a pharmaceutically acceptable salt, a prodrug, a composition, or an ester thereof, wherein A is a group of formulas (A), (B), (C) or (D); R1, R2, R3, R5 or R6 is H, or an optionally substituted and/or heteroatom-bearing alkyl, alkenyl, alkynyl, or cyclic group; Y and/or Z are CH2, O, S, SO, SO2, amino, amides, carbamates, ureas, or thiocarbonyl derivatives thereof, optionally substituted with an alkyl, alkenyl, or alkynyl group; n is from 1 to 5; X is a bond, an optionally substituted methylene or ethylene, an amino, O or S; Q is C(O), C(S), or SO2; m is from 0 to 6; R4 is OH, ═O (keto), NH2, or alkylamino, including esters, amides, and salts thereof; and W is C(O), C(S), S(O), or SO2. Optionally, R5 and R6, together with the N—W bond of formula (I), comprises a macrocyclic ring.Patent expiration dates:
- June 23, 2019✓
- June 23, 2019✓
- December 23, 2019✓
- June 23, 2019
Pseudopolymorphic forms of a HIV protease inhibitor
Patent 7,700,645
Issued: April 20, 2010
Inventor(s): Vermeersch; Hans Wim Pieter & Thoné; Daniel Joseph Christiaan & Janssens; Luc Donné Marie-Louise
Assignee(s): Tibotec Pharmaceuticals Ltd.
New pseudopolymorphic forms of (3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl(1S,2R)-3-[[(4-aminophenyl)sulfonyl](isobutyl)amino]-1-benzyl-2-hydroxypropylcarbamate and processes for producing them are disclosed.Patent expiration dates:
- December 26, 2026✓✓
- June 26, 2027✓
- December 26, 2026
α- and β- amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors
Patent RE42889
Issued: November 1, 2011
Inventor(s): Vazquez; Michael L. & Mueller; Richard A. & Talley; John J. & Getman; Daniel P. & DeCrescenzo; Gary A. & Freskos; John N. & Heintz; Robert M. & Bertenshaw; Deborah E.
Assignee(s): G.D. Searle LLC
α- and β-amino acid hydroxyethylamino sulfonamide compounds are effective as retroviral protease inhibitors, and in particular as inhibitors of HIV protease.Patent expiration dates:
- October 19, 2016✓
- April 19, 2017✓
- October 19, 2016
Related Exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
- Exclusivity expiration dates:
- June 23, 2011 - NEW CHEMICAL ENTITY
- October 21, 2011 - EXPANSION OF INDICATION TO INCLUDE TREATMENT OF HIV IN TREATMENT NAIVE ADULTS
- October 21, 2011 - TWO 400MG TABLETS ONCE DAILY, CO-ADMINISTERED WITH 100MG RITONAVIR
- December 18, 2011 - NEW STRENGTH
- December 18, 2011 - DOSING RECOMMENDATIONS FOR HIV INFECTED PEDIATRIC PATIENTS 6 TO LESS THAN 18 YEARS OF AGE
- December 23, 2011 - PEDIATRIC EXCLUSIVITY
- April 21, 2012 - PEDIATRIC EXCLUSIVITY
- June 18, 2012 - PEDIATRIC EXCLUSIVITY
- December 13, 2013 - 800/100 MG DARUNAVIR/RITONAVIR, ONCE DAILY, IN TREATMENT -EXPERIENCED HIV-1 INFECTED PATIENTS WITH NO DARUNIVIR RESISTANCE ASSOCIATED SUBSITUTIONS
- June 13, 2014 - PEDIATRIC EXCLUSIVITY
- December 16, 2014 - NEW PATIENT POPULATION
- December 16, 2014 - NEW DOSAGE FORM
- June 16, 2015 - PEDIATRIC EXCLUSIVITY
See also...
- Prezista Consumer Information (Drugs.com)
- Prezista Consumer Information (Wolters Kluwer)
- Prezista Consumer Information (Cerner Multum)
- Prezista Advanced Consumer Information (Micromedex)
- Prezista AHFS DI Monographs (ASHP)
- Darunavir Consumer Information (Wolters Kluwer)
- Darunavir Consumer Information (Cerner Multum)
- Darunavir Advanced Consumer Information (Micromedex)
- Darunavir AHFS DI Monographs (ASHP)
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