Arthrotec is a drug owned by Pfizer Inc. 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 Feb 11, 2014. Details of Arthrotec'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). | |||
| US5601843 | Pharmaceutical tablet composition |
Feb, 2014
(10 years ago) |
Expired
|
US patents provide insights into the exclusivity only within the United States, but Arthrotec 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 Arthrotec's family patents as well as insights into ongoing legal events on those patents.
Arthrotec's Family Patents
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Generic Launch
Generic Release Date:
Arthrotec's generic launch date based on the expiry of its last outstanding patent is estimated to be Feb 11, 2014 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Arthrotec Generic API suppliers:
Diclofenac Sodium; Misoprostol is the generic name for the brand Arthrotec. 7 different companies have already filed for the generic of Arthrotec, with Actavis Labs Fl Inc having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Arthrotec's generic
How can I launch a generic of Arthrotec before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Arthrotec's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Arthrotec'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 Arthrotec -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 50 mg/0.2 mg | 29 Jun, 2009 | 1 | 11 Feb, 2014 | Extinguished | |
| 75 mg/0.2 mg | 28 Nov, 2008 | 1 | 11 Feb, 2014 | Extinguished |
About Arthrotec
Arthrotec is a drug owned by Pfizer Inc. Arthrotec uses Diclofenac Sodium; Misoprostol as an active ingredient. Arthrotec was launched by Pfizer in 1997.
Approval Date:
Arthrotec was approved by FDA for market use on 24 December, 1997.
Active Ingredient:
Arthrotec uses Diclofenac Sodium; Misoprostol as the active ingredient. Check out other Drugs and Companies using Diclofenac Sodium; Misoprostol ingredient
Dosage:
Arthrotec is available in tablet, delayed release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 50MG;0.2MG | TABLET, DELAYED RELEASE | Prescription | ORAL |
| 75MG;0.2MG | TABLET, DELAYED RELEASE | Prescription | ORAL |