Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Merck
Mallinckrodt
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McKesson
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Last Updated: November 15, 2019

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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 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.

Drug Prices for DICLOFENAC POTASSIUM

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Recent Clinical Trials for DICLOFENAC POTASSIUM

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SponsorPhase
Cairo UniversityPhase 4
Nicholas SalavaEarly Phase 1
Haining Health-Coming Biotech Co., Ltd.Phase 2

See all DICLOFENAC POTASSIUM clinical trials

Recent Litigation for DICLOFENAC POTASSIUM

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District Court Litigation
Case NameDate
PATHEON SOFTGELS INC. v. PURACAP PHARMACEUTICAL LLC2018-10-05
DEPOMED, INC. v. BANNER PHARMACAPS INC.2013-07-26
NAUTILUS NEUROSCIENCES, INC. v. WOCKHARDT USA LLC2012-02-27

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Pharmacology for DICLOFENAC POTASSIUM
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
Sandoz DICLOFENAC POTASSIUM diclofenac potassium TABLET;ORAL 075582-001 Feb 23, 2001 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
Assertio CAMBIA diclofenac potassium FOR SOLUTION;ORAL 022165-001 Jun 17, 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
Mylan DICLOFENAC POTASSIUM diclofenac potassium TABLET;ORAL 075463-001 Jul 26, 1999 AB RX No Yes   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   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

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Johnson and Johnson
Dow
Medtronic
AstraZeneca
McKinsey

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