Velsipity is a drug owned by Pfizer Inc. It is protected by 7 US drug patents filed from 2023 to 2024 out of which none have expired yet. Velsipity's patents will be open to challenges from 13 October, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 21, 2036. Details of Velsipity'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. | |||
| US11091435 | Crystalline L-arginine salt of (R)-2-(7-(4-cyclopentyl-3-(trifluoromethyl)benzyloxy)-1,2,3, 4-tetrahydrocyclo-penta [b]indol-3-yl)acetic acid(compound1) for use in S1P1 receptor-associated disorders |
Jun, 2036
(11 years from now) | Active |
| US10301262 | Crystalline L-arginine salt of (R)-2-(7-(4-cyclopentyl-3-(trifluoromethyl)benzyloxy)-1,2,3,4-tetrahydrocyclo-penta [b]indol-3-yl)acetic acid(Compund1) for use in SIPI receptor-associated disorders |
Jun, 2036
(11 years from now) | Active |
| US8580841 | Substituted 1,2,3,4-tetrahydrocyclopenta[b]indol-3-yl)acetic acid derivatives useful in the treatment of autoimmune and inflammatory disorders |
Mar, 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). | |||
| US10676435 | Crystalline L-arginine salt of (R)-2-(7-(4-cyclopentyl-3-(trifluoromethyl)benzyloxy)-1,2,3,4-tetrahydrocyclo-penta [b]indol-3-yl)acetic acid(Compound 1) for use in SIPI receptor-associated disorders |
Jun, 2036
(11 years from now) | Active |
| US11884626 | Crystalline L-arginine salt of (R)-2-(7-(4-cyclopentyl-3-(trifluoromethyl)benzyloxy)-1,2,3,4-tetrahydrocyclo-penta [b]indol-3-yl)acetic acid(Compound1) for use in S1P1 receptor-associated disorders |
Jun, 2036
(11 years from now) | Active |
| US11007175 | Methods of treating conditions related to the S1P1 receptor |
Jan, 2036
(11 years from now) | Active |
| US9126932 | Substituted 1,2,3,4-tetrahydrocyclopenta[b]indol-3-yl)acetic acid derivatives useful in the treatment of autoimmune and inflammatory disorders |
Jul, 2029
(4 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 Velsipity's patents.
Latest Legal Activities on Velsipity's Patents
Given below is the list of recent legal activities going on the following patents of Velsipity.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Second letter to regulating agency to determine regulatory review period | 16 May, 2024 | US8580841 |
| Letter from FDA or Dept of Agriculture re PTE application | 08 May, 2024 | US8580841 |
| Recordation of Patent eGrant | 30 Jan, 2024 | US11884626 |
| Recordation of Patent Grant Mailed Critical | 30 Jan, 2024 | US11884626 |
| Mail Patent eGrant Notification | 30 Jan, 2024 | US11884626 |
| Patent Issue Date Used in PTA Calculation Critical | 30 Jan, 2024 | US11884626 |
| Patent eGrant Notification | 30 Jan, 2024 | US11884626 |
| Email Notification Critical | 30 Jan, 2024 | US11884626 |
| Email Notification Critical | 11 Jan, 2024 | US11884626 |
| Issue Notification Mailed Critical | 10 Jan, 2024 | US11884626 |
FDA has granted several exclusivities to Velsipity. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Velsipity, 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 Velsipity.
Exclusivity Information
Velsipity holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Velsipity's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Oct 12, 2028 |
US patents provide insights into the exclusivity only within the United States, but Velsipity 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 Velsipity's family patents as well as insights into ongoing legal events on those patents.
Velsipity's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Velsipity's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 21, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Velsipity Generics:
There are no approved generic versions for Velsipity as of now.
About Velsipity
Velsipity is a drug owned by Pfizer Inc. It is used for treating ulcerative colitis by administering Estrasimod Arginine. Velsipity uses Etrasimod Arginine as an active ingredient. Velsipity was launched by Pfizer in 2023.
Approval Date:
Velsipity was approved by FDA for market use on 12 October, 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 Velsipity is 12 October, 2023, its NCE-1 date is estimated to be 13 October, 2027.
Active Ingredient:
Velsipity uses Etrasimod Arginine as the active ingredient. Check out other Drugs and Companies using Etrasimod Arginine ingredient
Treatment:
Velsipity is used for treating ulcerative colitis by administering Estrasimod Arginine.
Dosage:
Velsipity is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 2MG BASE | TABLET | Prescription | ORAL |