Ojjaara is a drug owned by Glaxosmithkline Llc. It is protected by 4 US drug patents filed from 2023 to 2024 out of which none have expired yet. Ojjaara's patents will be open to challenges from 16 September, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be Dec 02, 2040. Details of Ojjaara'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. | |||
| USRE48285 | N-(cyanomethyl)-4-(2-(4-morpholinophenylamino)pyrimidin-4-yl)benzamide |
Jun, 2035
(10 years from now) | Active |
| US8486941 | Phenyl amino pyrimidine compounds and uses thereof |
Jan, 2030
(5 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). | |||
| US11963962 | Platelet count-agnostic methods of treating myelofibrosis |
Dec, 2040
(15 years from now) | Active |
| US9809559 | (N-(cyanomethyl)-4-(2-(4-morpholinophenylamino)pyrimidin-4-yl)benzamide |
Jun, 2035
(10 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 Ojjaara's patents.
Latest Legal Activities on Ojjaara's Patents
Given below is the list of recent legal activities going on the following patents of Ojjaara.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Second letter to regulating agency to determine regulatory review period | 08 Feb, 2024 | US8486941 |
| Letter from FDA or Dept of Agriculture re PTE application | 30 Jan, 2024 | US8486941 |
| Initial letter Re: PTE Application to regulating agency | 17 Nov, 2023 | US8486941 |
| Change in Power of Attorney (May Include Associate POA) Critical | 01 Nov, 2023 | US8486941 |
| Email Notification Critical | 01 Nov, 2023 | US8486941 |
| Patent Term Extension Application under 35 USC 156 Filed | 27 Oct, 2023 | US8486941 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 07 May, 2021 | US9809559 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 18 Jan, 2021 | US8486941 |
| Email Notification Critical | 22 May, 2019 | US8486941 |
| Change in Power of Attorney (May Include Associate POA) Critical | 22 May, 2019 | US8486941 |
FDA has granted several exclusivities to Ojjaara. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Ojjaara, 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 Ojjaara.
Exclusivity Information
Ojjaara holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Ojjaara's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 15, 2028 |
| Orphan Drug Exclusivity(ODE-441) | Sep 15, 2030 |
US patents provide insights into the exclusivity only within the United States, but Ojjaara 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 Ojjaara's family patents as well as insights into ongoing legal events on those patents.
Ojjaara's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Ojjaara's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Dec 02, 2040 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Ojjaara Generics:
There are no approved generic versions for Ojjaara as of now.
About Ojjaara
Ojjaara is a drug owned by Glaxosmithkline Llc. It is used for treating intermediate or high-risk myelofibrosis. Ojjaara uses Momelotinib Dihydrochloride as an active ingredient. Ojjaara was launched by Glaxosmithkline in 2023.
Approval Date:
Ojjaara was approved by FDA for market use on 15 September, 2023.
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 Ojjaara is 15 September, 2023, its NCE-1 date is estimated to be 16 September, 2027.
Active Ingredient:
Ojjaara uses Momelotinib Dihydrochloride as the active ingredient. Check out other Drugs and Companies using Momelotinib Dihydrochloride ingredient
Treatment:
Ojjaara is used for treating intermediate or high-risk myelofibrosis.
Dosage:
Ojjaara is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 200MG BASE | TABLET | Prescription | ORAL |
| EQ 150MG BASE | TABLET | Prescription | ORAL |
| EQ 100MG BASE | TABLET | Prescription | ORAL |