DICLOFENAC SODIUM - Generic Drug Details
✉ Email this page to a colleague
What are the generic sources for diclofenac sodium and what is the scope of patent protection?
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, Altaire Pharms Inc, Bausch And Lomb, Falcon Pharms, Rising, Rubicon, Sandoz, Sciegen Pharms Inc, 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-eight 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: | 128 |
Raw Ingredient (Bulk) Api Vendors: | 86 |
Clinical Trials: | 145 |
Patent Applications: | 7,113 |
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 |
---|---|
Jamia Millia Islamia | N/A |
University of Rijeka | N/A |
Fayoum University Hospital | N/A |
Generic filers with tentative approvals for DICLOFENAC SODIUM
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 1.5% W/W | SOLUTION;TOPICAL |
⤷ Sign Up | ⤷ Sign Up | 2% | SOLUTION;TOPICAL |
⤷ Sign Up | ⤷ Sign Up | 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 |
Anatomical Therapeutic Chemical (ATC) Classes for DICLOFENAC SODIUM
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Micro Labs | DICLOFENAC SODIUM | diclofenac sodium | TABLET, DELAYED RELEASE;ORAL | 074986-002 | Feb 26, 1999 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Haleon Us Holdings | VOLTAREN ARTHRITIS PAIN | diclofenac sodium | GEL;TOPICAL | 022122-001 | Oct 17, 2007 | OTC | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Bausch And Lomb | DICLOFENAC SODIUM | diclofenac sodium | SOLUTION/DROPS;OPHTHALMIC | 078792-001 | Dec 28, 2007 | AT | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Lupin Pharms | DICLOFENAC SODIUM | diclofenac sodium | SOLUTION;TOPICAL | 208021-001 | Sep 20, 2022 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Taro | DICLOFENAC SODIUM | diclofenac sodium | SOLUTION;TOPICAL | 203818-001 | Nov 26, 2014 | AT | RX | No | Yes | ⤷ 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 |
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 | ⤷ Sign Up | ⤷ Sign Up |
Javelin Pharms Inc | DYLOJECT | diclofenac sodium | SOLUTION;INTRAVENOUS | 022396-001 | Dec 23, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Fougera Pharms | SOLARAZE | diclofenac sodium | GEL;TOPICAL | 021005-001 | Oct 16, 2000 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | VOLTAREN | diclofenac sodium | TABLET, DELAYED RELEASE;ORAL | 019201-003 | Jul 28, 1988 | ⤷ Sign Up | ⤷ Sign Up |
Novartis | VOLTAREN | diclofenac sodium | SOLUTION/DROPS;OPHTHALMIC | 020037-001 | Mar 28, 1991 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for DICLOFENAC SODIUM
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 102846585 | Formulations of low dose diclofenac and beta-cyclodextrin | ⤷ Sign Up |
Hong Kong | 1134024 | DICLOFENAC GEL | ⤷ Sign Up |
Japan | 2010506952 | ⤷ Sign Up | |
Denmark | 2086504 | ⤷ Sign Up | |
China | 101410123 | Formulations of low dose diclofenac and beta-cyclodextrin | ⤷ Sign Up |
>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.