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 Aurobindo Pharma Ltd, Bionpharma Inc, Strides Pharma, Assertio, Alkem Labs Ltd, Annora Pharma, Par Form, Amici, Novartis, Novast Labs, Rk Pharma, Rubicon, Sandoz, Sun Pharm Industries, Teva, Umedica Labs Pvt Ltd, and Watson Labs Teva, and is included in eighteen 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-four patent family members in twenty-three countries.
There are eleven drug master file entries for diclofenac potassium. Twenty-eight suppliers are listed for this compound.
Summary for diclofenac potassium
International Patents: | 34 |
US Patents: | 10 |
Tradenames: | 4 |
Applicants: | 17 |
NDAs: | 18 |
Drug Master File Entries: | 11 |
Finished Product Suppliers / Packagers: | 28 |
Raw Ingredient (Bulk) Api Vendors: | 55 |
Clinical Trials: | 33 |
Patent Applications: | 6,844 |
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 |
What excipients (inactive ingredients) are in diclofenac potassium? | diclofenac potassium excipients list |
DailyMed Link: | diclofenac potassium at DailyMed |
Recent Clinical Trials for diclofenac potassium
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Danish Headache Center | Phase 4 |
Fayoum University Hospital | Phase 4 |
Cairo University | N/A |
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 | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ZIPSOR | Capsules | diclofenac potassium | 25 mg | 022202 | 1 | 2012-11-14 |
CAMBIA | Oral Solution (Sachet) | diclofenac potassium | 50 mg | 022165 | 1 | 2011-01-24 |
US Patents and Regulatory Information for diclofenac potassium
Expired US Patents for diclofenac potassium
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Assertio | CAMBIA | diclofenac potassium | FOR SOLUTION;ORAL | 022165-001 | Jun 17, 2009 | See Plans and Pricing | See Plans and Pricing |
Assertio | ZIPSOR | diclofenac potassium | CAPSULE;ORAL | 022202-001 | Jun 16, 2009 | See Plans and Pricing | See Plans and Pricing |
Assertio | CAMBIA | diclofenac potassium | FOR SOLUTION;ORAL | 022165-001 | Jun 17, 2009 | See Plans and Pricing | See Plans and Pricing |
Assertio | ZIPSOR | diclofenac potassium | CAPSULE;ORAL | 022202-001 | Jun 16, 2009 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for diclofenac potassium
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Jordan | 3352 | صيغ دايكلوفيناك وطرق استخدامه (Diclofenac formulations and methods of use) | See Plans and Pricing |
New Zealand | 564002 | Diclofenac formulations and methods of use | See Plans and Pricing |
Ecuador | SP077989 | FORMULACIÓN DE DICLOFENAC Y MÉTODOS PARA USARLAS | See Plans and Pricing |
Spain | 2912897 | See Plans and Pricing | |
Australia | 2006257072 | Diclofenac formulations and methods of use | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
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