DICLOFENAC Drug Patent Profile
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When do Diclofenac patents expire, and when can generic versions of Diclofenac launch?
Diclofenac is a drug marketed by Aurobindo Pharma Ltd, Bionpharma, Onesource Specialty, Alkem Labs Ltd, Annora Pharma, Ph Health, Taro, Torrent, Umedica, Chartwell Rx, Ingenus Pharms Llc, Rk Pharma, Rubicon Research, Senores Pharms, Sun Pharm Industries, Teva, Watson Labs Teva, Actavis Mid Atlantic, Alembic, Amneal, Amneal Pharms, Aurolife Pharma Llc, Cipla, Encube, Glenmark Pharms Ltd, Hikma, Padagis Israel, Perrigo Pharma Intl, Sun Pharma Canada, Altaire Pharms Inc, Bausch And Lomb, Falcon Pharms, Rising, Sandoz, Sciegen Pharms, Apotex, Epic Pharma Llc, Lupin, Lupin Pharms, Novel Labs Inc, Pai Holdings Pharm, Twi Pharms, Watson Labs Inc, Zydus Lifesciences, Actavis Elizabeth, Aurobindo Pharma Usa, Carlsbad, Micro Labs, Pliva, Roxane, Teva Pharms, Unique, Dexcel Ltd, Vpna, Actavis Labs Fl Inc, Exela Holdings, Yung Shin Pharm, and Zydus Pharms. and is included in eighty-three NDAs.
The generic ingredient in DICLOFENAC is diclofenac sodium; misoprostol. There are forty-seven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the diclofenac sodium; misoprostol profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Diclofenac
A generic version of DICLOFENAC was approved as diclofenac sodium; misoprostol by ACTAVIS LABS FL INC on July 9th, 2012.
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Questions you can ask:
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Summary for DICLOFENAC
| US Patents: | 0 |
| Applicants: | 58 |
| NDAs: | 83 |
| Drug Prices: | Drug price information for DICLOFENAC |
| Drug Sales Revenues: | Drug sales revenues for DICLOFENAC |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DICLOFENAC |
| What excipients (inactive ingredients) are in DICLOFENAC? | DICLOFENAC excipients list |
| DailyMed Link: | DICLOFENAC at DailyMed |
Recent Clinical Trials for DICLOFENAC
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation | PHASE4 |
| The Affiliated Hospital of Putian University | NA |
| Tata Main Hospital | PHASE4 |
Medical Subject Heading (MeSH) Categories for DICLOFENAC
Anatomical Therapeutic Chemical (ATC) Classes for DICLOFENAC
Paragraph IV (Patent) Challenges for DICLOFENAC
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ZORVOLEX | Capsules | diclofenac | 18 mg and 35 mg | 204592 | 1 | 2014-06-06 |
US Patents and Regulatory Information for DICLOFENAC
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pliva | DICLOFENAC SODIUM | diclofenac sodium | TABLET, DELAYED RELEASE;ORAL | 074432-002 | Jul 29, 1999 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Exela Holdings | DICLOFENAC SODIUM AND MISOPROSTOL | diclofenac sodium; misoprostol | TABLET, DELAYED RELEASE;ORAL | 200540-002 | Mar 14, 2014 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Rising | DICLOFENAC SODIUM | diclofenac sodium | SOLUTION;INTRAVENOUS | 208786-001 | Jun 18, 2019 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Perrigo Pharma Intl | DICLOFENAC SODIUM | diclofenac sodium | GEL;TOPICAL | 211253-001 | May 16, 2019 | OTC | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Umedica | DICLOFENAC SODIUM | diclofenac sodium | TABLET, DELAYED RELEASE;ORAL | 219945-002 | Nov 5, 2025 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
