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DICLOFENAC POTASSIUM Drug Patent Profile

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When do Diclofenac Potassium patents expire, and when can generic versions of Diclofenac Potassium launch?

Diclofenac Potassium is a drug marketed by Bionpharma Inc, Strides Pharma, Par Form, Rk Pharma, Rubicon, Sandoz, Sun Pharm Industries, Teva, and Watson Labs Teva. and is included in nine NDAs.

The generic ingredient in DICLOFENAC POTASSIUM is diclofenac potassium. There are forty-seven drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the diclofenac potassium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Diclofenac Potassium

A generic version of DICLOFENAC POTASSIUM was approved as diclofenac potassium by TEVA on August 6^th, 1998.

Summary for DICLOFENAC POTASSIUM

US Patents:	0
Applicants:	9
NDAs:	9
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	52
Clinical Trials:	30
Patent Applications:	2,563
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for DICLOFENAC POTASSIUM
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for DICLOFENAC POTASSIUM
DailyMed Link:	DICLOFENAC POTASSIUM at DailyMed

See drug prices for DICLOFENAC POTASSIUM

Recent Clinical Trials for DICLOFENAC POTASSIUM

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Fayoum University Hospital	Phase 4
Cairo University	N/A
Gesellschaft für Therapieforschung mbH	Phase 3

See all DICLOFENAC POTASSIUM clinical trials

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

D11AX	Other dermatologicals
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

M01AB	Acetic acid derivatives and related substances
M01A	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS, NON-STEROIDS
M01	ANTIINFLAMMATORY AND ANTIRHEUMATIC PRODUCTS
M	Musculo-skeletal system

M02AA	Antiinflammatory preparations, non-steroids for topical use
M02A	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M02	TOPICAL PRODUCTS FOR JOINT AND MUSCULAR PAIN
M	Musculo-skeletal system

S01BC	Antiinflammatory agents, non-steroids
S01B	ANTIINFLAMMATORY AGENTS
S01	OPHTHALMOLOGICALS
S	Sensory organs

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
Bionpharma Inc	DICLOFENAC POTASSIUM	diclofenac potassium	CAPSULE;ORAL	204648-001	Feb 23, 2016	AB	RX	No	No
Sandoz	DICLOFENAC POTASSIUM	diclofenac potassium	TABLET;ORAL	075582-001	Feb 23, 2001		DISCN	No	No
Rk Pharma	DICLOFENAC POTASSIUM	diclofenac potassium	TABLET;ORAL	075463-001	Jul 26, 1999	AB	RX	No	Yes
Sun Pharm Industries	DICLOFENAC POTASSIUM	diclofenac potassium	TABLET;ORAL	075470-001	Feb 21, 2002		DISCN	No	No
Strides Pharma	DICLOFENAC POTASSIUM	diclofenac potassium	CAPSULE;ORAL	210078-001	Dec 3, 2019		DISCN	No	No
Par Form	DICLOFENAC POTASSIUM	diclofenac potassium	FOR SOLUTION;ORAL	202964-001	May 2, 2016	AB	RX	No	No
Rubicon	DICLOFENAC POTASSIUM	diclofenac potassium	TABLET;ORAL	075229-001	Nov 20, 1998	AB	RX	No	No