Generic Stendra Availability
STENDRA (avanafil - tablet;oral)
Manufacturer: METUCHEN PHARMS
Approval date: April 27, 2012
Strength(s): 50MG [RLD], 100MG [RLD], 200MG [RLD]
Has a generic version of Stendra been approved?
No. There is currently no therapeutically equivalent version of Stendra available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Stendra. 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: Generic Drug FAQs.
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.
Aromatic nitrogen-containing 6-membered cyclic compounds
Issued: December 2, 2003
Inventor(s): Koichiro; Yamada & Kenji; Matsuki & Kenji; Omori & Kohei; Kikkawa
Assignee(s): Tanabe Seiyaku Co., Ltd.
An aromatic nitrogen-containing 6-membered cyclic compound of the formula (I): wherein Ring A is a substituted or unsubstituted nitrogen-containing heterocyclic group; R1 is a substituted or unsubstituted lower alkyl group, —NH—Q—R3 (R3 is a substituted or unsubstituted nitrogen containing heterocyclic group, and Q is a lower alkylene group or a single bond), or —NH—R4 (R4 is a substituted or unsubstituted cycloalkyl group); R2 is a substituted or unsubstituted aryl group; one of Y and Z is ═CH—, and the other is ═N—, or a pharmaceutically acceptable salt thereof, these compounds exhibiting excellent selective PDE V inhibitory activities, and hence, being useful in the prophylaxis or treatment of penile erectile dysfunction, etc.Patent expiration dates:
- April 27, 2025✓✓✓
- April 27, 2025
Preparations for oral administration
Issued: March 10, 2009
Inventor(s): Murakami; Hideki & Takebe; Shoji
Assignee(s): Mitsubishi Tanabe Pharma Corporation
The present invention provides a preparation for oral administration containing a medicinal substance having cGMP-specific phosphodiesterase inhibitory activity and showing decrease of solubility in the neutral and alkaline regions, wherein an acidic substance is compounded promote the dissolution of the medicinal substance in digestive tract and thus the efficacy can be expressed at the early stage after administration, and which preparation is useful in treatment of erectile dysfunction.Patent expiration dates:
- May 5, 2023✓
- May 5, 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:
- April 27, 2017 - NEW CHEMICAL ENTITY
- September 17, 2017 - REVISED DOSING SCHEDULE TO ADMINISTER AVANAFIL 15 MINUTES PRIOR TO SEXUAL ACTIVITY
More about Stendra (avanafil)
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- Drug class: impotence agents
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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.|