Cellcept is a drug owned by Roche Palo Alto Llc. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 18, 2014. Details of Cellcept'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). | |||
| US5688529 | Mycophenolate mofetil high dose oral suspensions |
Nov, 2014
(11 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but
Cellcept 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 Cellcept's family patents as well as insights into
ongoing legal events
on those patents.
Cellcept's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Cellcept:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Cellcept's generic launch date based on the expiry of its last outstanding patent is estimated to be Nov 18, 2014 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Cellcept Generic API suppliers:
Mycophenolate Mofetil is the generic name for the brand Cellcept. 25 different companies have already filed for the generic of Cellcept, with Alkem Labs Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Cellcept's generic
How can I launch a generic of Cellcept before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Cellcept's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Cellcept's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Cellcept -
| Strength | Submission Date | Expiration Date of Last Qualifying Patent | 180-Day Status | First Applicant Approval | Generic Competition Status |
|---|---|---|---|---|---|
| 25 Mar, 2011 | 18 Nov, 2014 | Deferred | 14 Nov, 2014 | Less |
Alternative Brands for Cellcept
There are several other brand drugs using the same active ingredient (Mycophenolate Mofetil) as Cellcept. 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 | |
|---|---|---|
| Azurity |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Mycophenolate Mofetil, Cellcept's active ingredient. Check the complete list of approved generic manufacturers for Cellcept
About Cellcept
Cellcept is a drug owned by Roche Palo Alto Llc. Cellcept uses Mycophenolate Mofetil as an active ingredient. Cellcept was launched by Roche in 1998.
Approval Date:
Cellcept was approved by FDA for market use on 01 October, 1998.
Active Ingredient:
Cellcept uses Mycophenolate Mofetil as the active ingredient. Check out other Drugs and Companies using Mycophenolate Mofetil ingredient
Dosage:
Cellcept is available in for suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 200MG/ML | FOR SUSPENSION | Prescription | ORAL |
Cellcept is a drug owned by Roche Palo Alto Llc. It is protected by 1 US drug patent filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 15, 2013. Details of Cellcept'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). | |||
| US5543408 | Crystalline anhydrous mycophenolate mofetil and intravenous formulation thereof |
Sep, 2013
(13 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but
Cellcept 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 Cellcept's family patents as well as insights into
ongoing legal events
on those patents.
Cellcept's Family Patents
Explore Our Curated Drug Screens
Clinical Trials
Recent Clinical Trials on Cellcept:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
Generic Launch
Generic Release Date:
Cellcept's generic launch date based on the expiry of its last outstanding patent is estimated to be Sep 15, 2013 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Cellcept Generic API suppliers:
Mycophenolate Mofetil Hydrochloride is the generic name for the brand Cellcept. 25 different companies have already filed for the generic of Cellcept, with Alkem Labs Ltd having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Cellcept's generic
Alternative Brands for Cellcept
There are several other brand drugs using the same active ingredient (Mycophenolate Mofetil Hydrochloride) as Cellcept. 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 | |
|---|---|---|
| Azurity |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Mycophenolate Mofetil Hydrochloride, Cellcept's active ingredient. Check the complete list of approved generic manufacturers for Cellcept
About Cellcept
Cellcept is a drug owned by Roche Palo Alto Llc. Cellcept uses Mycophenolate Mofetil Hydrochloride as an active ingredient. Cellcept was launched by Roche in 1998.
Approval Date:
Cellcept was approved by FDA for market use on 12 August, 1998.
Active Ingredient:
Cellcept uses Mycophenolate Mofetil Hydrochloride as the active ingredient. Check out other Drugs and Companies using Mycophenolate Mofetil Hydrochloride ingredient
Dosage:
Cellcept is available in injectable form for injection use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 500MG/VIAL | INJECTABLE | Prescription | INJECTION |