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Diclofenac potassium - Generic Drug Details
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What are the generic 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 sixty patent family members in thirty-one 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: | 60 |
US Patents: | 12 |
Tradenames: | 4 |
Applicants: | 11 |
NDAs: | 12 |
Drug Master File Entries: | 47 |
Suppliers / Packagers: | 16 |
Bulk Api Vendors: | 45 |
Clinical Trials: | 23 |
Patent Applications: | 3,590 |
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 |
---|---|
Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Phase 1 |
Cairo University | Phase 4 |
Nicholas Salava | Early Phase 1 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Assertio | ZIPSOR | diclofenac potassium | CAPSULE;ORAL | 022202-001 | Jun 16, 2009 | AB | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | |||
Watson Labs Teva | DICLOFENAC POTASSIUM | diclofenac potassium | TABLET;ORAL | 075152-001 | Nov 27, 1998 | 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 | Y | 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 | 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 |
---|---|---|
Portugal | 1890680 | Start Trial |
Canada | 2318128 | Start Trial |
Australia | 2117399 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
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