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Diclofenac potassium - Generic Drug Details
What are the generic drug sources for diclofenac potassium and what is the scope of freedom to operate?
Diclofenac potassium
is the generic ingredient in four branded drugs marketed by Bionpharma Inc, Assertio, Par Form, Novartis, Amici, Casi Pharms Inc, Mylan, Sandoz, Sun Pharm Industries, Teva, and Watson Labs Teva, and is included in twelve NDAs. There are twelve patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Diclofenac potassium has fifty-eight patent family members in thirty countries.
There are forty-seven drug master file entries for diclofenac potassium. Sixteen suppliers are listed for this compound.
Summary for diclofenac potassium
| International Patents: | 58 |
| US Patents: | 12 |
| Tradenames: | 4 |
| Applicants: | 11 |
| NDAs: | 12 |
| Drug Master File Entries: | 47 |
| Suppliers / Packagers: | 16 |
| Bulk Api Vendors: | 43 |
| Clinical Trials: | 22 |
| Patent Applications: | 3,539 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for diclofenac potassium |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for diclofenac potassium |
| DailyMed Link: | diclofenac potassium at DailyMed |
Recent Clinical Trials for diclofenac potassium
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Cairo University | Phase 4 |
| Nicholas Salava | Early Phase 1 |
| Haining Health-Coming Biotech Co., Ltd. | Phase 2 |
Recent Litigation for diclofenac potassium
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| PATHEON SOFTGELS INC. v. PURACAP PHARMACEUTICAL LLC | 2018-10-05 |
| DEPOMED, INC. v. BANNER PHARMACAPS INC. | 2013-07-26 |
| NAUTILUS NEUROSCIENCES, INC. v. WOCKHARDT USA LLC | 2012-02-27 |
Pharmacology for diclofenac potassium
| Drug Class | Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors |
| Physiological Effect | Decreased Prostaglandin Production |
Synonyms for diclofenac potassium
| 15307-81-0 |
| 15307-86-5 (Parent) |
| 2-((2,6-dichlorophenyl)amino)benzeneacetic acid, monopotassium salt |
| AB0013318 |
| AC-18735 |
| AKOS015889752 |
| AKOS015994733 |
| AN-8291 |
| Benzeneacetic acid, 2-((2,6-dichlorophenyl)amino)-, monopotassium salt |
| C14H10Cl2KNO2 |
| C14H10Cl2NO2.K |
| Cambia |
| Cambia (TN) |
| Cataflam |
| Cataflam (TN) |
| CGP 45840B |
| CGP-45840B |
| CHEBI:4508 |
| CHEMBL1200804 |
| D00903 |
| Diclofenac potassium (USAN) |
| Diclofenac potassium [USAN:USP] |
| Diclofenac potassium [USAN] |
| DTXSID30165212 |
| FT-0603076 |
| H866 |
| HMS3656D18 |
| I01-3215 |
| KS-5037 |
| KXZOIWWTXOCYKR-UHFFFAOYSA-M |
| L4D5UA6CB4 |
| LS-173441 |
| MolPort-005-937-655 |
| Potassium (o-(2,6-dichloroanilino)phenyl)acetate |
| potassium {2-[(2,6-dichlorophenyl)amino]phenyl}acetate |
| potassium 2-(2-((2,6-dichlorophenyl)amino)phenyl)acetate |
| potassium 2-(2-(2,6-dichlorophenylamino)phenyl)acetate |
| potassium 2-[2-(2,6-dichloroanilino)phenyl]acetate |
| potassium;2-[2-(2,6-dichloroanilino)phenyl]acetate |
| PubChem5895 |
| s3062 |
| SC-01315 |
| SCHEMBL40784 |
| SW196404-4 |
| UNII-L4D5UA6CB4 |
| Voltfast |
| Zipsor |
| Zipsor (TN) |
Paragraph IV (Patent) Challenges for DICLOFENAC POTASSIUM
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| ZIPSOR | CAPSULE;ORAL | diclofenac potassium | 022202 | 2012-11-14 |
| CAMBIA | FOR SOLUTION;ORAL | diclofenac potassium | 022165 | 2011-01-24 |
US Patents and Regulatory Information for diclofenac potassium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Casi Pharms Inc | DICLOFENAC POTASSIUM | diclofenac potassium | TABLET;ORAL | 075229-001 | Nov 20, 1998 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Teva | DICLOFENAC POTASSIUM | diclofenac potassium | TABLET;ORAL | 075219-001 | Aug 6, 1998 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Amici | DICLOFENAC POTASSIUM | diclofenac potassium | TABLET;ORAL | 076561-001 | Mar 18, 2004 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Assertio | ZIPSOR | diclofenac potassium | CAPSULE;ORAL | 022202-001 | Jun 16, 2009 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Start Trial | ||
| Assertio | ZIPSOR | diclofenac potassium | CAPSULE;ORAL | 022202-001 | Jun 16, 2009 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Assertio | ZIPSOR | diclofenac potassium | CAPSULE;ORAL | 022202-001 | Jun 16, 2009 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start 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 potassium
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Assertio | ZIPSOR | diclofenac potassium | CAPSULE;ORAL | 022202-001 | Jun 16, 2009 | Start Trial | Start Trial |
| Assertio | CAMBIA | diclofenac potassium | FOR SOLUTION;ORAL | 022165-001 | Jun 17, 2009 | Start Trial | Start Trial |
| Assertio | CAMBIA | diclofenac potassium | FOR SOLUTION;ORAL | 022165-001 | Jun 17, 2009 | Start Trial | Start Trial |
| Assertio | ZIPSOR | diclofenac potassium | CAPSULE;ORAL | 022202-001 | Jun 16, 2009 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for diclofenac potassium
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| World Intellectual Property Organization (WIPO) | 2006133954 | Start Trial |
| Japan | 2002509103 | Start Trial |
| Canada | 2932603 | Start Trial |
| Norway | 20003698 | Start Trial |
| Croatia | P20020045 | Start Trial |
| Russian Federation | 2432160 | Start Trial |
| >Country | >Patent Number | >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 verifification 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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Site Map
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.