Diclofenac sodium - Generic Drug Details
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What are the generic sources for diclofenac sodium and what is the scope of freedom to operate?
Diclofenac sodium
is the generic ingredient in nine branded drugs marketed by Actavis Mid Atlantic, Alembic, Amneal, Amneal Pharms, Aurolife Pharma Llc, Cipla, Encube, Glenmark Pharms Ltd, Hikma, Padagis Israel, Perrigo Pharma Intl, Taro, Fougera Pharms, Haleon Us Holdings, Akorn, Altaire Pharms Inc, Bausch And Lomb, Falcon Pharms, Rising, Rubicon, Sandoz, Novartis, Javelin Pharms Inc, Apotex, Epic Pharma Llc, Lupin Ltd, Lupin Pharms, Novel Labs Inc, Pai Holdings Pharm, Twi Pharms, Watson Labs Inc, Zydus Lifesciences, Horizon, Nuvo Pharms Inc, Actavis Elizabeth, Aurobindo Pharma Usa, Carlsbad, Chartwell Rx, Micro Labs, Pliva, Roxane, Teva, Teva Pharms, Unique, Dexcel Ltd, Riconpharma Llc, Vpna, Pfizer, Actavis Labs Fl Inc, Exela Holdings, Yung Shin Pharm, and Zydus Pharms, and is included in seventy-two NDAs. There are twenty patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Diclofenac sodium has forty-two patent family members in fifteen countries.
There are twenty-one drug master file entries for diclofenac sodium. One hundred and twenty-five suppliers are listed for this compound. There are three tentative approvals for this compound.
Summary for diclofenac sodium
| International Patents: | 42 |
| US Patents: | 20 |
| Tradenames: | 9 |
| Applicants: | 52 |
| NDAs: | 72 |
| Drug Master File Entries: | 21 |
| Finished Product Suppliers / Packagers: | 125 |
| Raw Ingredient (Bulk) Api Vendors: | 121 |
| Clinical Trials: | 141 |
| Patent Applications: | 7,170 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for diclofenac sodium |
| Drug Sales Revenues: | Drug sales revenues for diclofenac sodium |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for diclofenac sodium |
| What excipients (inactive ingredients) are in diclofenac sodium? | diclofenac sodium excipients list |
| DailyMed Link: | diclofenac sodium at DailyMed |
Recent Clinical Trials for diclofenac sodium
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Rijeka | N/A |
| Fayoum University Hospital | N/A |
| German University in Cairo | Phase 2 |
Generic filers with tentative approvals for DICLOFENAC SODIUM
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Try a Trial | ⤷ Try a Trial | 1.5% W/W | SOLUTION;TOPICAL |
| ⤷ Try a Trial | ⤷ Try a Trial | 2% | SOLUTION;TOPICAL |
| ⤷ Try a Trial | ⤷ Try a Trial | 2% | SOLUTION;TOPICAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for diclofenac sodium
| Drug Class | Nonsteroidal Anti-inflammatory Drug Anti-coagulant Calculi Dissolution Agent |
| Mechanism of Action | Cyclooxygenase Inhibitors Acidifying Activity Calcium Chelating Activity |
| Physiological Effect | Decreased Prostaglandin Production Decreased Coagulation Factor Activity |
Paragraph IV (Patent) Challenges for DICLOFENAC SODIUM
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| DYLOJECT | Injection | diclofenac sodium | 37.5 mg/mL, 1 mL single-dose vials | 022396 | 1 | 2015-12-15 |
| PENNSAID | Topical Solution | diclofenac sodium | 2.0% | 204623 | 1 | 2014-06-03 |
| PENNSAID | Topical Solution | diclofenac sodium | 1.5% | 020947 | 1 | 2012-07-11 |
| SOLARAZE | Topical Gel | diclofenac sodium | 3% | 021005 | 1 | 2009-12-16 |
US Patents and Regulatory Information for diclofenac sodium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Yung Shin Pharm | DICLOFENAC SODIUM AND MISOPROSTOL | diclofenac sodium; misoprostol | TABLET, DELAYED RELEASE;ORAL | 205143-002 | Feb 19, 2020 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Perrigo Pharma Intl | DICLOFENAC SODIUM | diclofenac sodium | GEL;TOPICAL | 211253-001 | May 16, 2019 | OTC | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Horizon | PENNSAID | diclofenac sodium | SOLUTION;TOPICAL | 204623-001 | Jan 16, 2014 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 |
Expired US Patents for diclofenac sodium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Fougera Pharms | SOLARAZE | diclofenac sodium | GEL;TOPICAL | 021005-001 | Oct 16, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
| Fougera Pharms | SOLARAZE | diclofenac sodium | GEL;TOPICAL | 021005-001 | Oct 16, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
| Fougera Pharms | SOLARAZE | diclofenac sodium | GEL;TOPICAL | 021005-001 | Oct 16, 2000 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for diclofenac sodium
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 6265964 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 2007112272 | ⤷ Try a Trial | |
| European Patent Office | 2522344 | Formulations de faible dose du diclofénac et de beta-cyclodextrine (Formulations of Low Dose Diclofenac and Beta-Cyclodextrin) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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