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Generic Dalvance Availability

Dalvance is a brand name of dalbavancin, approved by the FDA in the following formulation(s):

DALVANCE (dalbavancin hydrochloride - powder;iv (infusion))

  • Manufacturer: DURATA THERAPS INTL
    Approval date: May 23, 2014
    Strength(s): EQ 500MG BASE/VIAL [RLD]

Has a generic version of Dalvance been approved?

No. There is currently no therapeutically equivalent version of Dalvance available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Dalvance. 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.

  • Methods of administering dalbavancin for treatment of bacterial infections
    Patent 6,900,175
    Issued: May 31, 2005
    Inventor(s): Cavaleri; Marco & Jabes; Daniela & Henkel; Timothy & Malabarba; Adriano & Mosconi; Giorgio & Stogniew; Martin & White; Richard J.
    Assignee(s): Vicuron Pharmaceuticals Inc.
    The invention provides methods and compositions for treatment of bacterial infections. Methods of the invention include administration of dalbavancin for treatment of a bacterial infection, in particular a Gram-positive bacterial infection of skin and soft tissue. Dosing regimes include once weekly administration of dalbavancin, which often remains at therapeutic levels in the bloodstream for at least one week, providing prolonged therapeutic action against a bacterial infection.
    Patent expiration dates:
    • December 25, 2023
      ✓ 
      Patent use: TREATMENT OF BACTERIAL INFECTIONS USING A TWO-DOSE REGIMEN OF DALBAVANCIN.
  • Stable pharmaceutical compositions of dalbavancin and methods of administration
    Patent 7,115,564
    Issued: October 3, 2006
    Inventor(s): Cavaleri; Marco & Jabes; Daniela & Henkel; Timothy & Malabarba; Adriano & Mosconi; Giorgio & Stogniew; Martin & White; Richard J.
    Assignee(s): Vicuron Pharmaceuticals, Inc.
    The invention provides methods and compositions for treatment of bacterial infections. Methods of the invention include administration of dalbavancin for treatment of a bacterial infection, in particular a Gram-positive bacterial infection of skin and soft tissue. Dosing regimes include once weekly administration of dalbavancin, which often remains at therapeutic levels in the bloodstream for at least one week, providing prolonged therapeutic action against a bacterial infection.
    Patent expiration dates:
    • November 14, 2023
      ✓ 
      Drug product
  • Dalbavancin compositions for treatment of bacterial infections
    Patent 7,119,061
    Issued: October 10, 2006
    Inventor(s): Stogniew; Martin
    Assignee(s): Vicuron Pharmaceuticals, Inc.
    The invention provides methods and compositions for treatment of bacterial infections. Methods of the invention include administration of dalbavancin formulations for treatment of a bacterial infection, in particular a Gram-positive bacterial infection of skin and soft tissue. Dosing regimes include once weekly administration of dalbavancin, which often remains at therapeutic levels in the bloodstream for at least one week, providing prolonged therapeutic action against a bacterial infection.
    Patent expiration dates:
    • November 14, 2023
      ✓ 
      Drug product
  • Dalbavancin compositions for treatment of bacterial infections
    Patent 8,143,212
    Issued: March 27, 2012
    Inventor(s): Stogniew; Martin & Colombo; Luigi & Ciabatti; Romeo
    Assignee(s): Vicuron Pharmaceuticals Inc.
    The invention provides methods and compositions for treatment of bacterial infections. The composition may be a combination of factors, which include A0, A1, B1, B2, C0, C1, isoB0, and MAG, in the presence of low level solvent. Methods of the invention include administration of dalbavancin formulations for treatment of a bacterial infection, in particular a Gram-positive bacterial infection of skin and soft tissue. Dosing regimens include multiple dose administration of dalbavancin, which often remains at therapeutic levels in the bloodstream for at least one week, providing prolonged therapeutic action against a bacterial infection. Dosing regimens for renal patients are also included.
    Patent expiration dates:
    • November 14, 2023
      ✓ 
      Patent use: TREATMENT OF BACTERIAL INFECTIONS USING A TWO-DOSE REGIMEN OF DALBAVANCIN.

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:
    • January 20, 2019 - ADDITION OF A 1500MG-SINGLE-DOSE REGIMEN FOR THE TREATMENT OF ADULT PATIENTS WITH ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS (ABSSI)
    • May 23, 2019 - NEW CHEMICAL ENTITY
    • May 23, 2024 - GENERATING ANTIBIOTIC INCENTIVES NOW

Glossary

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
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