Cambia is a drug owned by Assertio Therapeutics Inc. It is protected by 6 US drug patents filed from 2013 to 2018. Out of these, 4 drug patents are active and 2 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 16, 2026. Details of Cambia'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. | |||
| US8097651 | Diclofenac formulations and methods of use |
Jun, 2026
(1 year, 5 months from now) | Active |
| US7759394 | Diclofenac formulations and methods of use |
Jun, 2026
(1 year, 5 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8927604 | Diclofenac formulations and methods of use |
Jun, 2026
(1 year, 5 months from now) | Active |
| US9827197 | Diclofenac formulations and methods of use |
Jun, 2026
(1 year, 5 months from now) | Active |
| US6974595 | Pharmaceutical compositions based on Diclofenae |
May, 2017
(7 years ago) |
Expired
|
| US7482377 | Pharmaceutical compositions and methods of treatment based on diclofenac |
May, 2017
(7 years ago) |
Expired
|
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 Cambia's patents.
Latest Legal Activities on Cambia's Patents
Given below is the list of recent legal activities going on the following patents of Cambia.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 17 Jul, 2023 | US8097651 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 06 Jul, 2022 | US8927604 |
| Payment of Maintenance Fee, 12th Yr, Small Entity | 20 Jan, 2022 | US7759394 |
| Email Notification Critical | 19 Jan, 2022 | US8927604 |
| Email Notification Critical | 19 Jan, 2022 | US9827197 |
| Change in Power of Attorney (May Include Associate POA) Critical | 19 Jan, 2022 | US9827197 |
| Change in Power of Attorney (May Include Associate POA) Critical | 19 Jan, 2022 | US8927604 |
| Correspondence Address Change Critical | 18 Jan, 2022 | US8927604 |
| Correspondence Address Change Critical | 18 Jan, 2022 | US9827197 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 28 May, 2021 | US9827197 |
FDA has granted several exclusivities to Cambia. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Cambia, 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 Cambia.
Exclusivity Information
Cambia holds 1 exclusivities. All of its exclusivities have expired in 2012. Details of Cambia's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Jun 17, 2012 |
US patents provide insights into the exclusivity only within the United States, but Cambia 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 Cambia's family patents as well as insights into ongoing legal events on those patents.
Cambia's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Cambia's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 16, 2026 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Cambia Generic API suppliers:
Diclofenac Potassium is the generic name for the brand Cambia. 17 different companies have already filed for the generic of Cambia, with Amici Pharma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Cambia's generic
How can I launch a generic of Cambia before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Cambia's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Cambia'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 Cambia -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 50 mg | 24 Jan, 2011 | 1 | 16 Jun, 2026 | Extinguished |
Alternative Brands for Cambia
Cambia which is used for relieving acute migraine attacks in adults, with or without aura., has several other brand drugs in the same treatment category and using the same active ingredient (Diclofenac Potassium). 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.
Apart from drugs working in same treatment category, there are also some brand drugs where treatment area is different, but the active ingredient used is same i.e. Diclofenac Potassium. Given below is the list of those drugs and companies owning them.
| Drug Owner | Drug Name | |
|---|---|---|
| Assertio |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Diclofenac Potassium, Cambia's active ingredient. Check the complete list of approved generic manufacturers for Cambia
About Cambia
Cambia is a drug owned by Assertio Therapeutics Inc. It is used for relieving acute migraine attacks in adults, with or without aura. Cambia uses Diclofenac Potassium as an active ingredient. Cambia was launched by Assertio in 2009.
Approval Date:
Cambia was approved by FDA for market use on 17 June, 2009.
Active Ingredient:
Cambia uses Diclofenac Potassium as the active ingredient. Check out other Drugs and Companies using Diclofenac Potassium ingredient
Treatment:
Cambia is used for relieving acute migraine attacks in adults, with or without aura.
Dosage:
Cambia is available in for solution form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 50MG | FOR SOLUTION | Prescription | ORAL |