DICLOFENAC POTASSIUM Drug Patent Profile
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When do Diclofenac Potassium patents expire, and when can generic versions of Diclofenac Potassium launch?
Diclofenac Potassium is a drug marketed by Aurobindo Pharma Ltd, Bionpharma, Strides Pharma, Alkem Labs Ltd, Annora Pharma, Par Form, Chartwell Rx, Novast Labs, Rk Pharma, Rubicon, Senores Pharms, Sun Pharm Industries, Teva, Umedica, and Watson Labs Teva. and is included in fifteen NDAs.
The generic ingredient in DICLOFENAC POTASSIUM is diclofenac potassium. There are forty-seven drug master file entries for this compound. Thirty-five suppliers are listed for this compound. Additional details are available on the diclofenac potassium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Diclofenac Potassium
A generic version of DICLOFENAC POTASSIUM was approved as diclofenac potassium by TEVA on August 6th, 1998.
Summary for DICLOFENAC POTASSIUM
| US Patents: | 0 |
| Applicants: | 15 |
| NDAs: | 15 |
| Finished Product Suppliers / Packagers: | 30 |
| Raw Ingredient (Bulk) Api Vendors: | 58 |
| Clinical Trials: | 33 |
| Patent Applications: | 4,575 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for DICLOFENAC POTASSIUM |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DICLOFENAC POTASSIUM |
| What excipients (inactive ingredients) are in DICLOFENAC POTASSIUM? | DICLOFENAC POTASSIUM excipients list |
| DailyMed Link: | DICLOFENAC POTASSIUM at DailyMed |
Recent Clinical Trials for DICLOFENAC POTASSIUM
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Danish Headache Center | Phase 4 |
| Fayoum University Hospital | Phase 4 |
| Cairo University | N/A |
Pharmacology for DICLOFENAC POTASSIUM
| Drug Class | Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors |
| Physiological Effect | Decreased Prostaglandin Production |
Anatomical Therapeutic Chemical (ATC) Classes for DICLOFENAC POTASSIUM
Paragraph IV (Patent) Challenges for DICLOFENAC POTASSIUM
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ZIPSOR | Capsules | diclofenac potassium | 25 mg | 022202 | 1 | 2012-11-14 |
| CAMBIA | Oral Solution (Sachet) | diclofenac potassium | 50 mg | 022165 | 1 | 2011-01-24 |
US Patents and Regulatory Information for DICLOFENAC POTASSIUM
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aurobindo Pharma Ltd | DICLOFENAC POTASSIUM | diclofenac potassium | CAPSULE;ORAL | 213875-001 | Oct 19, 2021 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Chartwell Rx | DICLOFENAC POTASSIUM | diclofenac potassium | TABLET;ORAL | 075582-001 | Feb 23, 2001 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Alkem Labs Ltd | DICLOFENAC POTASSIUM | diclofenac potassium | FOR SOLUTION;ORAL | 216635-001 | Jul 20, 2022 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
