Generic Orlynvah Availability
Last updated on Apr 10, 2025.
Orlynvah is a brand name of probenecid/sulopenem, approved by the FDA in the following formulation(s):
ORLYNVAH (probenecid; sulopenem etzadroxil - tablet;oral)
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Manufacturer: ITERUM THERAP
Approval date: October 25, 2024
Strength(s): 500MG;500MG [RLD]
Is there a generic version of Orlynvah available?
No. There is currently no therapeutically equivalent version of Orlynvah available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Orlynvah. 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 FAQ.
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.
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Combinations of beta-lactam compounds and probenecid and uses thereof
Patent 11,478,428
Issued: October 25, 2022
Inventor(s): Dunne; Michael et al.
Assignee(s): Iterum Therapeutics International Limited (Dublin, IE)The present disclosure relates to bilayer tablets comprising a second layer comprising a β-lactam compound or a pharmaceutically acceptable salt thereof; and a first layer comprising probenecid or a pharmaceutically acceptable salt thereof. The present disclosure also relates to methods of treating or preventing a disease using the bilayer tablets.
Patent expiration dates:
- December 23, 2039✓✓
- December 23, 2039
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Combinations of β-lactam compounds and probenecid and uses thereof
Patent 11,554,112
Issued: January 17, 2023
Inventor(s): Dunne; Michael
Assignee(s): Herum Therapeutics International Limited (Dublin, IE)The present disclosure relates to combinations of a β-lactam compound or a pharmaceutically acceptable salt thereof and probenecid or a pharmaceutically acceptable salt thereof. The present disclosure also relates to methods of treating or preventing a disease via administering to subjects in need thereof a β-lactam compound or a pharmaceutically acceptable salt thereof and probenecid or a pharmaceutically acceptable salt thereof.
Patent expiration dates:
- April 1, 2039✓
- April 1, 2039
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Combinations of β-lactam compounds and probenecid and uses thereof
Patent 12,109,197
Issued: October 8, 2024
Inventor(s): Dunne; Michael
Assignee(s): Iterum Therapeutics International Limited (Dublin, IE)The present disclosure relates to combinations of a β-lactam compound or a pharmaceutically acceptable salt thereof and probenecid or a pharmaceutically acceptable salt thereof. The present disclosure also relates to methods of treating or preventing a disease via administering to subjects in need thereof a β-lactam compound or a pharmaceutically acceptable salt thereof and probenecid or a pharmaceutically acceptable salt thereof.
Patent expiration dates:
- April 1, 2039✓
- April 1, 2039
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Penem prodrugs
Patent 7,795,243
Issued: September 14, 2010
Inventor(s): Brighty; Katherine E. et al.
Assignee(s): Pfizer, Inc. (New York, NY)Orally bioavailable prodrugs of sulopenem, e.g., ##STR00001## and solvates and hydrates thereof, preparation thereof, formulation thereof, and use to treat and prevent infection in mammals such as humans. This abstract is not limiting to the invention.
Patent expiration dates:
- June 3, 2029✓✓✓
- June 3, 2029
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:
- October 25, 2029 - NEW CHEMICAL ENTITY
- October 25, 2034 - GENERATING ANTIBIOTIC INCENTIVES NOW
More about Orlynvah (probenecid / sulopenem)
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Glossary
| Term | Definition |
|---|---|
| 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. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.