Generic Prezista Availability
Prezista is a brand name of darunavir, approved by the FDA in the following formulation(s):
PREZISTA (darunavir ethanolate - suspension; oral)
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Manufacturer: JANSSEN PRODS
Approval date: December 16, 2011
Strength(s): EQ 100MG BASE/ML [RLD]
PREZISTA (darunavir ethanolate - tablet; oral)
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Manufacturer: JANSSEN PRODS
Approval date: February 25, 2008
Strength(s): EQ 600MG BASE -
Manufacturer: JANSSEN PRODS
Approval date: October 21, 2008
Strength(s): EQ 400MG BASE -
Manufacturer: JANSSEN PRODS
Approval date: December 18, 2008
Strength(s): EQ 150MG BASE, EQ 75MG BASE -
Manufacturer: JANSSEN PRODS
Approval date: November 9, 2012
Strength(s): EQ 800MG BASE [RLD]
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.
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.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✓✓
- December 1, 2015✓✓
- June 1, 2016✓
- December 1, 2015
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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✓
- June 26, 2016✓
- December 26, 2016✓
- June 26, 2016
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.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✓✓
- February 13, 2015✓
- August 13, 2014
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&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✓✓✓
- August 25, 2012✓✓✓
- February 25, 2013✓
- August 25, 2012
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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✓
- June 26, 2016✓
- December 26, 2016✓
- June 26, 2016
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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✓
- June 23, 2019✓
- December 23, 2019✓
- June 23, 2019
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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
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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
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α- and β-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors
Patent RE43596
Issued: August 21, 2012
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:- May 9, 2017✓✓
- November 9, 2017✓
- November 9, 2017✓✓
- May 9, 2017
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α- and β-amino acid hydroxyethylamino sulfonamides useful as retroviral protease inhibitors
Patent RE43802
Issued: November 13, 2012
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 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:
- 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 DOSAGE FORM
- December 16, 2014 - NEW PATIENT POPULATION
- June 16, 2015 - PEDIATRIC EXCLUSIVITY
- February 1, 2016 - UPDATE LABELING WITH ONCE DAILY DOSING IN HIV-1 INFECTED, TREATMENT-NAIVE PEDIATRIC PATIENTS 12 TO LESS THAN 18 YEARS OF AGE
- August 1, 2016 - PEDIATRIC EXCLUSIVITY
See also...
- Prezista Consumer Information (Drugs.com)
- Prezista Consumer Information (Wolters Kluwer)
- Prezista suspension 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 suspension Consumer Information (Wolters Kluwer)
- Darunavir Consumer Information (Cerner Multum)
- Darunavir Advanced Consumer Information (Micromedex)
- Darunavir AHFS DI Monographs (ASHP)
Glossary
| Term | Definition |
|---|---|
| Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
| Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
| RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
