Intrarosa is a drug owned by Millicent Pharma Ltd. It is protected by 3 US drug patents filed in 2016 out of which none have expired yet. Intrarosa's patents have been open to challenges since 16 November, 2020. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 19, 2031. Details of Intrarosa's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8268806 | Pharmaceutical compositions |
Mar, 2031
(5 years from now) | Active |
| US8957054 | Pharmaceutical compositions |
Jan, 2030
(4 years from now) | Active |
| US8629129 | Pharmaceutical compositions |
Aug, 2028
(3 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Intrarosa's patents.
Latest Legal Activities on Intrarosa's Patents
Given below is the list of recent legal activities going on the following patents of Intrarosa.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 06 Feb, 2024 | US8268806 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Jul, 2022 | US8957054 |
| Withdrawal of Application for PTE Critical | 20 Apr, 2022 | US8629129 |
| Patent Term Extension Certificate Critical | 19 Apr, 2022 | US8957054 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 29 Apr, 2021 | US8629129 |
| Notice of Final Determination -Election Required | 12 Mar, 2021 | US8957054 |
| Notice of Final Determination -Election Required | 12 Mar, 2021 | US8629129 |
| FDA Final Eligibility Letter Critical | 13 Oct, 2020 | US8629129 |
| FDA Final Eligibility Letter Critical | 13 Oct, 2020 | US8957054 |
| transaction for FDA Determination of Regulatory Review Period | 20 Feb, 2020 | US8629129 |
FDA has granted several exclusivities to Intrarosa. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Intrarosa, 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 Intrarosa.
Exclusivity Information
Intrarosa holds 1 exclusivities. All of its exclusivities have expired in 2021. Details of Intrarosa's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 16, 2021 |
US patents provide insights into the exclusivity only within the United States, but Intrarosa 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 Intrarosa's family patents as well as insights into ongoing legal events on those patents.
Intrarosa's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Intrarosa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 19, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Intrarosa Generics:
There are no approved generic versions for Intrarosa as of now.
About Intrarosa
Intrarosa is a drug owned by Millicent Pharma Ltd. It is used for managing dyspareunia in menopausal women with vulvar and vaginal atrophy. Intrarosa uses Prasterone as an active ingredient. Intrarosa was launched by Millicent in 2016.
Approval Date:
Intrarosa was approved by FDA for market use on 16 November, 2016.
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 Intrarosa is 16 November, 2016, its NCE-1 date is estimated to be 16 November, 2020.
Active Ingredient:
Intrarosa uses Prasterone as the active ingredient. Check out other Drugs and Companies using Prasterone ingredient
Treatment:
Intrarosa is used for managing dyspareunia in menopausal women with vulvar and vaginal atrophy.
Dosage:
Intrarosa is available in insert form for vaginal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 6.5MG | INSERT | Prescription | VAGINAL |