Generic Doribax Availability
DORIBAX (doripenem - injectable; iv (infusion))
Manufacturer: JANSSEN PHARMS
Approval date: October 12, 2007
Strength(s): 500MG/VIAL [RLD]
Manufacturer: JANSSEN PHARMS
Approval date: October 5, 2010
Has a generic version of Doribax been approved?
No. There is currently no therapeutically equivalent version of Doribax available.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Doribax. 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.
Issued: May 31, 1994
Inventor(s): Nishitani; Yasuhiro & Irie; Tadashi
Assignee(s): Shionogi Seiyaku Kabushiki Kaisha
A pyrrolidylthiocarbapenem derivative represented by Formula I is provided: ##STR1## wherein R.sup.1 is hydrogen or lower alkyl; R.sup.2, R.sup.3 and R.sup.4 are hydrogen, lower alkyl which can be substituted or an amino protecting group independently, or R.sup.2 and R.sup.3 together with a nitrogen atom to which R.sup.2 and R.sup.3 are bonded form a saturated or unsaturated cyclic group, or R.sup.2 and R.sup.4, or R.sup.3 and R.sup.4 together with two nitrogen atoms and one sulfur atom in the sufamide group form a saturated or unsaturated cyclic group; each cyclic group can further include at least one atom selected from the group consisting of oxygen, sulfur and nitrogen, and each cyclic group can be substituted; X.sup.1 is hydrogen or a hydroxy protecting group; X.sup.2 is hydrogen, a carboxy protecting group, an ammonio group, an alkali metal or an alkaline-earth metal; and Y.sup.2 is hydrogen or an amino protecting group.Patent expiration dates:
- June 5, 2015✓✓✓
- June 5, 2015
Crystal form of pyrrolidylthiocarbapenem derivative
Issued: August 21, 2012
Inventor(s): Saitoh; Izumi & Takahira; Masayuki & Kawakita; Toshio & Yoshioka; Yasuyuki
Assignee(s): Shiongi & Co., Ltd.
Novel crystals of a pyrrolidylthiocarbapenem derivative having excellent stability is provided. According to the present invention, a crystal of (+)-(4R,5S,6S)-6-[(1R)-1-hydroxyethyl]-4-methyl-7-oxo-3[[(3S,5S)-5-(sulfamoylaminomethyl)p yrrolidin-3-yl]thio]-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid having a diffraction pattern in powder X-ray diffraction having main peaks at diffraction angles (2θ) of about 13.04, 14.98, 15.88, 16.62, 20.62, 21.06, 22.18, 23.90, 26.08, 28.22 and 28.98 (degrees) and a crystal of said compound having a diffraction pattern in powder X-ray diffraction having main peaks at diffraction angles (2θ) of about 6.62, 13.04, 15.44, 16.58, 17.64, 20.88, 23.26, 25.02 and 25.52 (degrees) are provided.Patent expiration dates:
- March 30, 2021✓✓
- March 30, 2021
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:
- October 12, 2012 - NEW CHEMICAL ENTITY
- Doribax Consumer Information (Drugs.com)
- Doribax Consumer Information (Wolters Kluwer)
- Doribax Consumer Information (Cerner Multum)
- Doribax Advanced Consumer Information (Micromedex)
- Doribax AHFS DI Monographs (ASHP)
- Doripenem Consumer Information (Wolters Kluwer)
- Doripenem Consumer Information (Cerner Multum)
- Doripenem Intravenous Advanced Consumer Information (Micromedex)
- Doripenem AHFS DI Monographs (ASHP)
|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.|