Orlynvah is a drug owned by Iterum Therapeutics Us Ltd. It is protected by 4 US drug patents filed in 2024 out of which none have expired yet. Orlynvah's patents will be open to challenges from 25 October, 2033. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 23, 2039. Details of Orlynvah's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US7795243 | Penem prodrugs |
Jun, 2029
(4 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11478428 | Combinations of beta-lactam compounds and probenecid and uses thereof |
Dec, 2039
(14 years from now) | Active |
| US12109197 | Combinations of β-lactam compounds and probenecid and uses thereof |
Apr, 2039
(14 years from now) | Active |
| US11554112 | Combinations of β-lactam compounds and probenecid and uses thereof |
Apr, 2039
(14 years from now) | Active |
FDA has granted several exclusivities to Orlynvah. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Orlynvah, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Orlynvah.
Exclusivity Information
Orlynvah holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2034. Details of Orlynvah's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 25, 2029 |
| Generating Antibiotic Incentives Now(GAIN) | Oct 25, 2034 |
US patents provide insights into the exclusivity only within the United States, but Orlynvah is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Orlynvah's family patents as well as insights into ongoing legal events on those patents.
Orlynvah's Family Patents
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Generic Launch
Generic Release Date:
Orlynvah's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 23, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Orlynvah Generics:
There are no approved generic versions for Orlynvah as of now.
About Orlynvah
Orlynvah is a drug owned by Iterum Therapeutics Us Ltd. Orlynvah uses Probenecid; Sulopenem Etzadroxil as an active ingredient. Orlynvah was launched by Iterum Therap in 2024.
Approval Date:
Orlynvah was approved by FDA for market use on 25 October, 2024.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Orlynvah is 25 October, 2024, its NCE-1 date is estimated to be 25 October, 2033.
Active Ingredient:
Orlynvah uses Probenecid; Sulopenem Etzadroxil as the active ingredient. Check out other Drugs and Companies using Probenecid; Sulopenem Etzadroxil ingredient
Dosage:
Orlynvah is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 500MG;500MG | TABLET | Prescription | ORAL |