Sfrowasa is a drug owned by Mylan Specialty Lp. It is protected by 1 US drug patent filed in 2013 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jul 24, 2027. Details of Sfrowasa'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. | |||
| US7645801 | Reduced irritant enema for treatment of inflammatory bowel disease (IBD) |
Jul, 2027
(2 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 Sfrowasa's patents.
Latest Legal Activities on Sfrowasa's Patents
Given below is the list of recent legal activities going on the following patents of Sfrowasa.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 29 Jun, 2021 | US7645801 |
| Entity Status Set To Undiscounted (Initial Default Setting or Status Change) | 11 Jul, 2013 | US7645801 |
| Patent Issue Date Used in PTA Calculation Critical | 12 Jan, 2010 | US7645801 |
| Recordation of Patent Grant Mailed Critical | 12 Jan, 2010 | US7645801 |
| Issue Notification Mailed Critical | 23 Dec, 2009 | US7645801 |
| Application Is Considered Ready for Issue Critical | 11 Dec, 2009 | US7645801 |
| Dispatch to FDC | 11 Dec, 2009 | US7645801 |
| Issue Fee Payment Verified Critical | 10 Dec, 2009 | US7645801 |
| Issue Fee Payment Received Critical | 10 Dec, 2009 | US7645801 |
| Response to Reasons for Allowance | 07 Dec, 2009 | US7645801 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Sfrowasa and ongoing litigations to help you estimate the early arrival of Sfrowasa generic.
Sfrowasa's Litigations
Sfrowasa been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Apr 23, 2008, against patent number US7645801. The petitioner , challenged the validity of this patent, with Bala VENKATARAMAN et al as the respondent. Click below to track the latest information on how companies are challenging Sfrowasa's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US7645801 | April, 2008 |
Decision
(08 Dec, 2008) | Bala VENKATARAMAN et al | |
US patents provide insights into the exclusivity only within the United States, but Sfrowasa 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 Sfrowasa's family patents as well as insights into ongoing legal events on those patents.
Sfrowasa's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Sfrowasa's generic launch date based on the expiry of its last outstanding patent is estimated to be Jul 24, 2027 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Sfrowasa Generic API suppliers:
Mesalamine is the generic name for the brand Sfrowasa. 21 different companies have already filed for the generic of Sfrowasa, with Zydus Pharms having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Sfrowasa's generic
Alternative Brands for Sfrowasa
There are several other brand drugs using the same active ingredient (Mesalamine) as Sfrowasa. Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |||
|---|---|---|---|---|
| Abbvie |
| |||
| Apil |
| |||
| Salix |
| |||
| Takeda Pharms Usa |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Mesalamine, Sfrowasa's active ingredient. Check the complete list of approved generic manufacturers for Sfrowasa
About Sfrowasa
Sfrowasa is a drug owned by Mylan Specialty Lp. Sfrowasa uses Mesalamine as an active ingredient. Sfrowasa was launched by Mylan Speciality Lp in 1987.
Approval Date:
Sfrowasa was approved by FDA for market use on 24 December, 1987.
Active Ingredient:
Sfrowasa uses Mesalamine as the active ingredient. Check out other Drugs and Companies using Mesalamine ingredient
Dosage:
Sfrowasa is available in enema form for rectal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 4GM/60ML | ENEMA | Prescription | RECTAL |