Vioxx is a drug owned by Merck Research Laboratories Div Merck Co Inc. It is protected by 8 US drug patents filed in 2013 out of which all have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Nov 06, 2017. Details of Vioxx'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). | |||
|
US6063811 (Pediatric) | Compositions for a once day treatment of cyclooxygenase-2 mediated diseases |
Nov, 2017
(7 years ago) |
Expired
|
| US6063811 | Compositions for a once day treatment of cyclooxygenase-2 mediated diseases |
May, 2017
(7 years ago) |
Expired
|
|
US5691374 (Pediatric) | Diaryl-5-oxygenated-2-(5H) -furanones as COX-2 inhibitors |
Nov, 2015
(9 years ago) |
Expired
|
| US5691374 | Diaryl-5-oxygenated-2-(5H) -furanones as COX-2 inhibitors |
May, 2015
(9 years ago) |
Expired
|
|
US6239173 (Pediatric) | 3-phenyl-4-(4(methylsulfonyl)phenyl)-2-(5H)-furanone as a cox-2 inhibitor |
Dec, 2013
(11 years ago) |
Expired
|
|
US5474995 (Pediatric) | Phenyl heterocycles as cox-2 inhibitors |
Dec, 2013
(11 years ago) |
Expired
|
| US6239173 | 3-phenyl-4-(4(methylsulfonyl)phenyl)-2-(5H)-furanone as a cox-2 inhibitor |
Jun, 2013
(11 years ago) |
Expired
|
| US5474995 | Phenyl heterocycles as cox-2 inhibitors |
Jun, 2013
(11 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Vioxx 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 Vioxx's family patents as well as insights into ongoing legal events on those patents.
Vioxx's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Vioxx's generic launch date based on the expiry of its last outstanding patent is estimated to be Nov 06, 2017 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Vioxx Generics:
There are no approved generic versions for Vioxx as of now.
How can I launch a generic of Vioxx before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Vioxx's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Vioxx'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 Vioxx -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 12.5 mg, 25 mg and 50 mg |
About Vioxx
Vioxx is a drug owned by Merck Research Laboratories Div Merck Co Inc. It is used for relieving symptoms of osteoarthritis, rheumatoid arthritis, acute pain, primary dysmenorrhea, and acute migraine attacks in adults. Vioxx uses Rofecoxib as an active ingredient. Vioxx was launched by Merck in 1999.
Approval Date:
Vioxx was approved by FDA for market use on 20 May, 1999.
Active Ingredient:
Vioxx uses Rofecoxib as the active ingredient. Check out other Drugs and Companies using Rofecoxib ingredient
Treatment:
Vioxx is used for relieving symptoms of osteoarthritis, rheumatoid arthritis, acute pain, primary dysmenorrhea, and acute migraine attacks in adults.
Dosage:
Vioxx is available in the following dosage forms - tablet form for oral use, suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 25MG | TABLET | Discontinued | ORAL |
| 12.5MG/5ML | SUSPENSION | Discontinued | ORAL |
| 25MG/5ML | SUSPENSION | Discontinued | ORAL |
| 50MG | TABLET | Discontinued | ORAL |
| 12.5MG | TABLET | Discontinued | ORAL |