Idvynso is a drug owned by Merck Sharp And Dohme Llc. It is protected by 2 US drug patents filed in 2026 out of which none have expired yet. Idvynso's patents will be open to challenges from 20 April, 2030. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 30, 2032. Details of Idvynso'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. | |||
| US8486975 | Non-nucleoside reverse transcriptase inhibitors |
Aug, 2032
(6 years from now) | Active |
| US7339053 | 4'-C-Substituted-2-Haloadenosine Derivative |
May, 2027
(10 months from now) | Active |
FDA has granted several exclusivities to Idvynso. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Idvynso, 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
Idvynso.
Exclusivity Information
Idvynso holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2031. Details of Idvynso's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Apr 20, 2031 |
US patents provide insights into the exclusivity only within the United States, but
Idvynso 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 Idvynso's family patents as well as insights into
ongoing legal events
on those patents.
Idvynso's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Idvynso's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 30, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Idvynso Generics:
There are no approved generic versions for Idvynso as of now.
About Idvynso
Idvynso is a drug owned by Merck Sharp And Dohme Llc. Idvynso uses Doravirine; Islatravir as an active ingredient. Idvynso was launched by Merck in 2026.
Approval Date:
Idvynso was approved by FDA for market use on 20 April, 2026.
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 Idvynso is 20 April, 2026, its NCE-1 date is estimated to be 20 April, 2030.
Active Ingredient:
Idvynso uses Doravirine; Islatravir as the active ingredient. Check out other Drugs and Companies using Doravirine; Islatravir ingredient
Dosage:
Idvynso is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 100MG;0.25MG | TABLET | Prescription | ORAL |