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Diclofenac potassium - Generic Drug Details
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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, Strides Pharma, Assertio, Par Form, Novartis, Amici, Mylan, Rubicon, Sandoz, Sun Pharm Industries, Teva, and Watson Labs Teva, and is included in thirteen NDAs. There are ten patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Diclofenac potassium has thirty-two patent family members in twenty-three countries.
There are forty-seven drug master file entries for diclofenac potassium. Twelve suppliers are listed for this compound.
Summary for diclofenac potassium
| International Patents: | 32 |
| US Patents: | 10 |
| Tradenames: | 4 |
| Applicants: | 12 |
| NDAs: | 13 |
| Drug Master File Entries: | 47 |
| Suppliers / Packagers: | 12 |
| Bulk Api Vendors: | 49 |
| Clinical Trials: | 24 |
| Patent Applications: | 3,677 |
| 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 |
|---|---|
| Aswan University Hospital | N/A |
| Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Phase 1 |
| Cairo University | Phase 4 |
Pharmacology for diclofenac potassium
| Drug Class | Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors |
| Physiological Effect | Decreased Prostaglandin Production |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Assertio | ZIPSOR | diclofenac potassium | CAPSULE;ORAL | 022202-001 | Jun 16, 2009 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
| Novartis | CATAFLAM | diclofenac potassium | TABLET;ORAL | 020142-002 | Nov 24, 1993 | DISCN | Yes | 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 | Start Trial | |||
| Teva | DICLOFENAC POTASSIUM | diclofenac potassium | TABLET;ORAL | 075219-001 | Aug 6, 1998 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Assertio | CAMBIA | diclofenac potassium | FOR SOLUTION;ORAL | 022165-001 | Jun 17, 2009 | AB | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | |
| Strides Pharma | DICLOFENAC POTASSIUM | diclofenac potassium | CAPSULE;ORAL | 210078-001 | Dec 3, 2019 | DISCN | 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 | 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 | 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for diclofenac potassium
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Russian Federation | 2432160 | Start Trial |
| South Korea | 20080024202 | Start Trial |
| Peru | 20070074 | Start Trial |
| Mexico | 2007016072 | Start Trial |
| Portugal | 1890680 | Start Trial |
| Canada | 2932603 | Start Trial |
| Jordan | 3352 | 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 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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