DICLOFENAC POTASSIUM - Generic Drug Details
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What are the generic sources for diclofenac potassium and what is the scope of patent protection?
Diclofenac potassium
is the generic ingredient in four branded drugs marketed by Aurobindo Pharma Ltd, Bionpharma, Strides Pharma, Assertio, Alkem Labs Ltd, Annora Pharma, Endo Operations, Taro, Amici, Novartis, Chartwell Rx, Novast Labs, Rk Pharma, Rubicon, Senores Pharms, Sun Pharm Industries, Teva, Umedica, and Watson Labs Teva, and is included in twenty 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. Forty-two suppliers are listed for this compound.
Summary for DICLOFENAC POTASSIUM
International Patents: | 34 |
US Patents: | 10 |
Tradenames: | 4 |
Applicants: | 19 |
NDAs: | 20 |
Drug Master File Entries: | 11 |
Finished Product Suppliers / Packagers: | 42 |
Raw Ingredient (Bulk) Api Vendors: | 58 |
Clinical Trials: | 33 |
Patent Applications: | 6,778 |
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 |
Anatomical Therapeutic Chemical (ATC) Classes for DICLOFENAC POTASSIUM
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
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Assertio | ZIPSOR | diclofenac potassium | CAPSULE;ORAL | 022202-001 | Jun 16, 2009 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Assertio | ZIPSOR | diclofenac potassium | CAPSULE;ORAL | 022202-001 | Jun 16, 2009 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Assertio | ZIPSOR | diclofenac potassium | CAPSULE;ORAL | 022202-001 | Jun 16, 2009 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Bionpharma | DICLOFENAC POTASSIUM | diclofenac potassium | CAPSULE;ORAL | 204648-001 | Feb 23, 2016 | AB | RX | 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 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 | ⤷ Sign Up | ⤷ Sign Up |
Assertio | ZIPSOR | diclofenac potassium | CAPSULE;ORAL | 022202-001 | Jun 16, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Assertio | ZIPSOR | diclofenac potassium | CAPSULE;ORAL | 022202-001 | Jun 16, 2009 | ⤷ Sign Up | ⤷ Sign Up |
Assertio | CAMBIA | diclofenac potassium | FOR SOLUTION;ORAL | 022165-001 | Jun 17, 2009 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for DICLOFENAC POTASSIUM
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 104856959 | Diclofenac formulations and methods of use | ⤷ Sign Up |
South Africa | 200710858 | Diclofenac formulations and methods of use | ⤷ Sign Up |
China | 101272768 | Diclofenac formulations and methods of use | ⤷ Sign Up |
Australia | 2006257072 | Diclofenac formulations and methods of use | ⤷ Sign Up |
Spain | 2641889 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
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