Drug facts
BrandOrbactiv (Oritavancin Diphosphate)
No generic oritavancin diphosphate is approved; the latest Orbactiv patent or exclusivity in the Orange Book runs to 07/16/2035.
Orbactiv was first approved by the FDA on 08/06/2014 under NDA 206334; the application holder is Melinta Therapeutics LLC.
Holder Melinta Therapeutics LLCApplication NDA 206334Approved 08/06/2014
01Patents and exclusivity
When competition can legally begin. A generic can launch once both exclusivity and the last listed patent expire, unless a court or settlement says otherwise.
3,180days until the latest patent expires
ExclusivityPatent onlyOpen to generics
Today
Approved08/06/2014
Last patent07/16/2035
20152018202120242027203020332036
- Latest patent
- 07/16/2035Orbactiv Orange Book
02Competition
- Generics
- No generic approved Orange Book
Every listingEach listing and maker behind the generics count.
Price erosionHow NADAC moves as generics enter.
PrescribersWho prescribes it, from Medicare data.
Available in the full Orbactiv profile.See what is included
03Supply and price
- FDA drug shortage
- ClearNot on the current shortage list FDA shortages
04Product
- Application holder
- Melinta Therapeutics LLC Orange Book
- Application
- NDA 206334 Orange Book
- First approved
- 08/06/2014 Orange Book
- Dosage forms
- powder
- Routes
- intravenous
- Other brand names
- Kimyrsa
Sources: FDA Orange Book, FDA Purple Book, FDA drug shortages, FDA enforcement reports and CMS NADAC, read through QOPE. Not medical or legal advice.