Generic Tivicay Availability
TIVICAY (dolutegravir sodium - tablet;oral)
Manufacturer: VIIV HLTHCARE
Approval date: August 12, 2013
Strength(s): EQ 50MG BASE [RLD]
Manufacturer: VIIV HLTHCARE
Approval date: June 9, 2016
Strength(s): EQ 10MG BASE, EQ 25MG BASE
Has a generic version of Tivicay been approved?
No. There is currently no therapeutically equivalent version of Tivicay available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Tivicay. 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.
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.
Substituted 5-hydroxy-3,4,6,9,9a, 10-hexanhydro-2h-1-oxa04a,8a-diaza-anthracene-6,10-dioness
Issued: March 6, 2012
Inventor(s): Johns; Brian Alvin & Kawasuji; Takashi & Taishi; Teruhiko & Taoda; Yoshiyuki
Assignee(s): Shionogi & Co., Ltd. GlaxoSmithKline LLC
The present invention is directed to a class of substituted 5-hydroxy-3,4,6,9,9a,10-hexahydro-2H-1-oxa-4a,8a-diaza-anthracene-6,10-diones useful as anti-HIV agents. The compounds have the formula: Z═O; R20, R21, R22, R23, R24 and R25 independently are hydrogen, C1-C8 alkyl, (C6-C14)aryl-(C1-C8)alkyl, C6-C14 aryl, or alkoxy; the stereochemistry of an asymmetric carbon represented by * shows R- or S-configuration, or a mixture thereof; RX is hydrogen; R14 is hydrogen or optionally substituted lower alkyl; R3 is hydrogen; R1 is hydrogen or lower alkyl; R is halogen; and m is 1, 2 or 3; or a pharmaceutically acceptable salt thereof.Patent expiration dates:
- October 5, 2027✓✓
- October 5, 2027
Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates
Issued: January 26, 2016
Assignee(s): SHIONOGI & CO., LTD. ViiV Healthcare Company
A synthesis approach providing an early ring attachment via a bromination to compound 1-1 yielding compound II-II, whereby a final product such as AA can be synthesized. In particular, the 2,4-difluorophenyl-containing sidechain is attached before creation of the additional ring Q.Patent expiration dates:
- December 8, 2029✓✓
- December 8, 2029
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:
- July 30, 2018 - UPDATE TO LABELING WITH WEEK 48 RESULTS FROM VIKING-4 IN ANTIRETROVIRAL THERAPY (ART) - EXPERIENCED INTEGRASE STRAND TRANSFER INHIBITOR (INSTI) - RESISTANT SUBJECTS
- August 12, 2018 - NEW CHEMICAL ENTITY
More about Tivicay (dolutegravir)
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|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.|