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-six 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: | 126 |
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 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Horizon | PENNSAID | diclofenac sodium | SOLUTION;TOPICAL | 204623-001 | Jan 16, 2014 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Taro | DICLOFENAC SODIUM | diclofenac sodium | GEL;TOPICAL | 206298-001 | Apr 28, 2016 | AB | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Riconpharma Llc | DICLOFENAC SODIUM | diclofenac sodium | TABLET, EXTENDED RELEASE;ORAL | 216275-001 | Sep 23, 2022 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Novartis | VOLTAREN | diclofenac sodium | SOLUTION/DROPS;OPHTHALMIC | 020037-001 | Mar 28, 1991 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Actavis Labs Fl Inc | DICLOFENAC SODIUM AND MISOPROSTOL | diclofenac sodium; misoprostol | TABLET, DELAYED RELEASE;ORAL | 201089-001 | Jul 9, 2012 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Rising | DICLOFENAC SODIUM | diclofenac sodium | SOLUTION;INTRAVENOUS | 208786-001 | Jun 18, 2019 | DISCN | 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 |
Expired US Patents for diclofenac sodium
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Falcon Pharms | DICLOFENAC SODIUM | diclofenac sodium | SOLUTION/DROPS;OPHTHALMIC | 020809-001 | May 4, 1998 | ⤷ 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 |
Novartis | VOLTAREN | diclofenac sodium | SOLUTION/DROPS;OPHTHALMIC | 020037-001 | Mar 28, 1991 | ⤷ Try a Trial | ⤷ Try a Trial |
Javelin Pharms Inc | DYLOJECT | diclofenac sodium | SOLUTION;INTRAVENOUS | 022396-001 | Dec 23, 2014 | ⤷ Try a Trial | ⤷ Try a Trial |
Novartis | VOLTAREN | diclofenac sodium | TABLET, DELAYED RELEASE;ORAL | 019201-001 | Jul 28, 1988 | ⤷ 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 |
---|---|---|---|
European Patent Office | 2626063 | Gel de diclofénac (Diclofenac gel) | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2008049020 | ⤷ Try a Trial | |
European Patent Office | 2004203 | FORMULATIONS DE DICLOFÉNAC ET DE CYCLODEXTRINE BÊTA À FAIBLE DOSAGE (FORMULATIONS OF LOW DOSE DICLOFENAC AND BETA-CYCLODEXTRIN) | ⤷ Try a Trial |
Canada | 2647348 | FORMULATIONS DE DICLOFENAC ET DE CYCLODEXTRINE BETA A FAIBLEDOSAGE (FORMULATIONS OF LOW DOSE DICLOFENAC AND BETA-CYCLODEXTRIN) | ⤷ Try a Trial |
Japan | 6157305 | ⤷ Try a Trial | |
Mexico | 2008012495 | FORMULACIONES DE DOSIS BAJA DE DICLOFENACO Y BETA-CICLODEXTRINA. (FORMULATIONS OF LOW DOSE DICLOFENAC AND BETA-CYCLODEXTRIN.) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
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