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, Endo Operations, Taro, Chartwell Rx, Novast Labs, Rk Pharma, Rubicon, Senores Pharms, Sun Pharm Industries, Teva, Umedica, and Watson Labs Teva. and is included in sixteen NDAs.
The generic ingredient in DICLOFENAC POTASSIUM is diclofenac potassium. There are forty-seven drug master file entries for this compound. Forty-two 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.
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Questions you can ask:
- What is the 5 year forecast for DICLOFENAC POTASSIUM?
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- What is Average Wholesale Price for DICLOFENAC POTASSIUM?
Summary for DICLOFENAC POTASSIUM
| US Patents: | 0 |
| Applicants: | 16 |
| NDAs: | 16 |
| Finished Product Suppliers / Packagers: | 37 |
| Raw Ingredient (Bulk) Api Vendors: | 58 |
| Clinical Trials: | 33 |
| Patent Applications: | 4,575 |
| 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Watson Labs Teva | DICLOFENAC POTASSIUM | diclofenac potassium | TABLET;ORAL | 075152-001 | Nov 27, 1998 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Taro | DICLOFENAC POTASSIUM | diclofenac potassium | FOR SOLUTION;ORAL | 218011-001 | Jun 14, 2024 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Alkem Labs Ltd | DICLOFENAC POTASSIUM | diclofenac potassium | FOR SOLUTION;ORAL | 216635-001 | Jul 20, 2022 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Rubicon | DICLOFENAC POTASSIUM | diclofenac potassium | TABLET;ORAL | 075229-001 | Nov 20, 1998 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Chartwell Rx | DICLOFENAC POTASSIUM | diclofenac potassium | TABLET;ORAL | 075582-001 | Feb 23, 2001 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Teva | DICLOFENAC POTASSIUM | diclofenac potassium | TABLET;ORAL | 075219-001 | Aug 6, 1998 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
