Generic Kyleena Availability
KYLEENA (levonorgestrel - intrauterine device;intrauterine)
Has a generic version of Kyleena been approved?
No. There is currently no therapeutically equivalent version of Kyleena available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Kyleena. 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.
Delivery system and a manufacturing process of a delivery system
Issued: August 7, 2007
Inventor(s): Hallinen; Esa & Lyytikäinen; Heikki & Järvelä; Pentti & Kivi; Ilkka
Assignee(s): Schering Oy
A delivery system including a body construction (7) and at least one capsule (8) containing a pharmaceutical composition, the capsule having at least a first end and a second end. The body construction (7, 12, 34) has at least two locking parts (9, 10), each locking part (9, 10) having at least a first end and a second end, the first end of each locking part (9, 10) having a surface adapted to face and cover one of the at least first and second ends of the capsule (8). The diameter of at least one of the locking parts varies along its length between the first end and the second end, and the capsule (8) is mounted between the at least two locking parts. Also disclosed is a manufacturing process of a delivery system, the system including a body construction and at least one capsule containing a pharmaceutical composition.Patent expiration dates:
- November 13, 2023✓
- November 13, 2023
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:
- September 16, 2019 - NEW PRODUCT
More about Kyleena (levonorgestrel)
|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.|