DICLOFENAC SODIUM Drug Patent Profile
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When do Diclofenac Sodium patents expire, and when can generic versions of Diclofenac Sodium launch?
Diclofenac Sodium is a drug marketed by Actavis Mid Atlantic, Alembic, Amneal, Amneal Pharms, Aurolife Pharma Llc, Cipla, Encube, Glenmark Pharms Ltd, Hikma, Padagis Israel, Perrigo Pharma Intl, Taro, Altaire Pharms Inc, Bausch And Lomb, Falcon Pharms, Rising, Rubicon, Sandoz, Sciegen Pharms Inc, Apotex, Epic Pharma Llc, Lupin Ltd, Lupin Pharms, Novel Labs Inc, Pai Holdings Pharm, Twi Pharms, Watson Labs Inc, Zydus Lifesciences, Actavis Elizabeth, Aurobindo Pharma Usa, Carlsbad, Chartwell Rx, Micro Labs, Pliva, Roxane, Teva, Teva Pharms, Unique, Dexcel Ltd, Riconpharma Llc, Vpna, Actavis Labs Fl Inc, Exela Holdings, Yung Shin Pharm, and Zydus Pharms. and is included in sixty-three NDAs.
The generic ingredient in DICLOFENAC SODIUM 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 Sodium
A generic version of DICLOFENAC SODIUM was approved as diclofenac sodium; misoprostol by ACTAVIS LABS FL INC on July 9th, 2012.
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Summary for DICLOFENAC SODIUM
| US Patents: | 0 |
| Applicants: | 45 |
| NDAs: | 63 |
| Finished Product Suppliers / Packagers: | 126 |
| Raw Ingredient (Bulk) Api Vendors: | 86 |
| Clinical Trials: | 145 |
| Patent Applications: | 4,203 |
| Drug Prices: | Drug price information 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 |
See drug prices for DICLOFENAC SODIUM
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 |
Pharmacology for DICLOFENAC SODIUM
| Drug Class | Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors |
| Physiological Effect | Decreased Prostaglandin Production |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Actavis Labs Fl Inc | DICLOFENAC SODIUM AND MISOPROSTOL | diclofenac sodium; misoprostol | TABLET, DELAYED RELEASE;ORAL | 201089-002 | Jul 9, 2012 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Aurobindo Pharma Usa | DICLOFENAC SODIUM | diclofenac sodium | TABLET, DELAYED RELEASE;ORAL | 075281-003 | Feb 12, 2002 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Rising | DICLOFENAC SODIUM | diclofenac sodium | SOLUTION;TOPICAL | 206715-001 | Aug 7, 2017 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Micro Labs | DICLOFENAC SODIUM | diclofenac sodium | TABLET, DELAYED RELEASE;ORAL | 074986-002 | Feb 26, 1999 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Teva Pharms | DICLOFENAC SODIUM | diclofenac sodium | TABLET, DELAYED RELEASE;ORAL | 074459-001 | Jun 25, 1997 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Chartwell Rx | DICLOFENAC SODIUM | diclofenac sodium | TABLET, DELAYED RELEASE;ORAL | 074376-001 | Sep 28, 1995 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pliva | DICLOFENAC SODIUM | diclofenac sodium | TABLET, DELAYED RELEASE;ORAL | 074432-002 | Jul 29, 1999 | DISCN | No | No | ⤷ 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 |
|---|---|---|---|---|---|---|---|
| Falcon Pharms | DICLOFENAC SODIUM | diclofenac sodium | SOLUTION/DROPS;OPHTHALMIC | 020809-001 | May 4, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| Falcon Pharms | DICLOFENAC SODIUM | diclofenac sodium | SOLUTION/DROPS;OPHTHALMIC | 020809-001 | May 4, 1998 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for DICLOFENAC SODIUM
See the table below for patents covering DICLOFENAC SODIUM around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| European Patent Office | 0739197 | CONSERVATION DE COMPOSITIONS DE MEDICAMENTS OPHTALMIQUES CONTENANT DES COMPOSES D'AMMONIUM QUATERNAIRE POLYMERE (PRESERVED OPHTHALMIC DRUG COMPOSITIONS CONTAINING POLYMERIC QUATERNARY AMMONIUM COMPOUNDS) | ⤷ Sign Up |
| Germany | 69522094 | ⤷ Sign Up | |
| Denmark | 0739197 | ⤷ Sign Up | |
| Australia | 4162296 | ⤷ Sign Up | |
| Australia | 686917 | ⤷ Sign Up | |
| Portugal | 739197 | ⤷ Sign Up | |
| Hong Kong | 1012556 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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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.
ISSN: 2162-2639
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