.

Flexible Flat-Rate Plans

Flat-rate pricing for predictable budgeting

Short-term plans for project- or client-based billing

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Diclofenac sodium - Generic Drug Details

« Back to Dashboard
Diclofenac sodium is the generic ingredient in eight branded drugs marketed by Apotex Inc, Novartis, Dexcel Ltd, Fougera Pharms, Falcon Pharms, Actavis Elizabeth, Taro, Glaxosmithkline Cons, Horizon Pharma, Teva, Alcon Pharms Ltd, Lupin Ltd, Pliva, Tolmar, Akorn, Nuvo Res Inc, Watson Labs Inc, Mylan, Rising Pharms Inc, Teva Pharms, Unique Pharm Labs, Teligent Pharma Inc, Sandoz, Amneal Pharms, Novel Labs Inc, Mylan Pharms Inc, Altaire Pharms Inc, Carlsbad, Nostrum Labs, Roxane, Bausch And Lomb, Vpna, Actavis Mid Atlantic, Paddock Llc, Javelin Pharms Inc, Gd Searle Llc, Exela Pharma Scs Llc, and Actavis Labs Fl Inc, and is included in forty-seven NDAs. There are twenty patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has two hundred and twenty-three patent family members in thirty-three countries.

There are forty-six drug master file entries for diclofenac sodium. Seventy-six suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for Generic Name: diclofenac sodium

Tradenames:8
Patents:20
Applicants:38
NDAs:47
Drug Master File Entries: see list46
Suppliers / Packaging: see list76
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Dermatological Agents
Ophthalmic Agents
Formulation / Manufacturing:see details

Tentative approvals for DICLOFENAC SODIUM

Applicant Application No. Form Dosage
<disabled><disabled>SOLUTION;TOPICAL2%
<disabled><disabled>SOLUTION;TOPICAL2%
<disabled><disabled>SOLUTION;TOPICAL2%

Clinical Trials for: diclofenac sodium

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan
DICLOFENAC SODIUM
diclofenac sodium
TABLET, EXTENDED RELEASE;ORAL076152-001Dec 13, 2001RXNo<disabled><disabled>
Horizon Pharma
PENNSAID
diclofenac sodium
SOLUTION;TOPICAL204623-001Jan 16, 2014RXYes8,741,956<disabled> <disabled>
Sandoz
DICLOFENAC SODIUM
diclofenac sodium
TABLET, DELAYED RELEASE;ORAL074376-001Sep 28, 1995RXYes<disabled><disabled>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Orange Book Patents for Generic Ingredient: diclofenac sodium

These historical archives are available as an add-on to one-year subscriptions.
See the Signup Form for more information.

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Fougera Pharms
SOLARAZE
diclofenac sodium
GEL;TOPICAL021005-001Oct 16, 20005,929,048<disabled>
Fougera Pharms
SOLARAZE
diclofenac sodium
GEL;TOPICAL021005-001Oct 16, 20005,792,753<disabled>
Fougera Pharms
SOLARAZE
diclofenac sodium
GEL;TOPICAL021005-001Oct 16, 20005,639,738<disabled>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Non-Orange Book Patents for Generic Ingredient: diclofenac sodium

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,811,410 Method of administering of a hyaluronic acid and an NSAID to decrease side effects of the NSAID<disabled in preview>
6,048,844 Treatment of conditions and disease<disabled in preview>
6,218,373 Formulations containing hyaluronic acid<disabled in preview>
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: diclofenac sodium

Country Document Number Estimated Expiration
Austria244020<disabled in preview>
Hong Kong44797<disabled in preview>
South Korea20140038575<disabled in preview>
This preview shows a limited data set
Subscribe for full access, or try a Trial

The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

`abc