Pharsight

1. Diclofenac Sodium patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5653972	FALCON PHARMS	Preserved ophthalmic drug compositions containing polymeric quaternary ammonium compounds	Nov, 2014 (9 years ago)
US5603929	FALCON PHARMS	Preserved ophthalmic drug compositions containing polymeric quaternary ammonium compounds	Nov, 2014 (9 years ago)

Market Authorisation Date: 04 May, 1998

Treatment: Treating or controlling ocular inflammation which comprises topically administering to affected eye a composition comprising an nsaid, a polymeric quaternary ammonium compound and boric acid

Dosage: SOLUTION/DROPS;OPHTHALMIC

Strength	Dosage	Availability
0.1%	SOLUTION/DROPS;OPHTHALMIC	Discontinued

DICLOFENAC SODIUM family patents

2. Dyloject patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US6407079	JAVELIN PHARMS INC	Pharmaceutical compositions containing drugs which are instable or sparingly soluble in water and methods for their preparation	Jun, 2019 (4 years ago)
US8946292	JAVELIN PHARMS INC	Formulations of low dose diclofenac and beta-cyclodextrin	Mar, 2027 (2 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Dec 23, 2017

Market Authorisation Date: 23 December, 2014

Treatment: Management of pain

Dosage: SOLUTION;INTRAVENOUS

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
37.5 mg/mL, 1 mL single-dose vials	15 Dec, 2015	1	18 Jun, 2019	22 Mar, 2027	Eligible

Strength	Dosage	Availability
37.5MG/ML (37.5MG/ML) Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION;INTRAVENOUS	Discontinued

DYLOJECT family patents

3. Pennsaid patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9101591	HORIZON	Diclofenac topical formulation	Oct, 2027 (3 years from now)
US9339551	HORIZON	Diclofenac topical formulation	Oct, 2027 (3 years from now)
US9168305	HORIZON	Diclofenac topical formulation	Oct, 2027 (3 years from now)
US9220784	HORIZON	Diclofenac topical formulation	Oct, 2027 (3 years from now)
US9132110	HORIZON	Treatment of pain with topical diclofenac	Oct, 2027 (3 years from now)
US9066913	HORIZON	Diclofenac topical formulation	Oct, 2027 (3 years from now)
US9339552	HORIZON	Diclofenac topical formulation	Oct, 2027 (3 years from now)
US9168304	HORIZON	Diclofenac topical formulation	Oct, 2027 (3 years from now)
US9539335	HORIZON	Diclofenac topical formulation	Oct, 2027 (3 years from now)
US8871809	HORIZON	Diclofenac topical formulation	Oct, 2027 (3 years from now)
US8563613	HORIZON	Diclofenac topical formulation	Oct, 2027 (3 years from now)
US8252838	HORIZON	Diclofenac topical formulation	Apr, 2028 (4 years from now)
US9415029	HORIZON	Treatment of pain with topical diclofenac	Jul, 2029 (5 years from now)
US9370501	HORIZON	Treatment of pain with topical diclofenac	Jul, 2029 (5 years from now)
US8741956	HORIZON	Treatment of pain with topical diclofenac	Jul, 2029 (5 years from now)
US9375412	HORIZON	Treatment of pain with topical diclofenac	Jul, 2029 (5 years from now)
US8618164	HORIZON	Treatment of pain with topical diclofenac compounds	Jul, 2029 (5 years from now)
US8217078	HORIZON	Treatment of pain with topical diclofenac	Jul, 2029 (5 years from now)
US8546450	HORIZON	Treatment of pain with topical diclofenac compounds	Aug, 2030 (6 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Product(NP)	Jan 16, 2017

Market Authorisation Date: 16 January, 2014

Treatment: Use of topical diclofenac for treating pain; Use of topical diclofenac sodium for treating pain; Use of topical diclofenac on a joint for treating osteoarthritis; Combination use of topical diclofenac...

Dosage: SOLUTION;TOPICAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.015	11 Jul, 2012	1	27 May, 2014	10 Jul, 2029	Eligible
0.02	03 Jun, 2014	1		09 Aug, 2030	Extinguished

Strength	Dosage	Availability
2%	SOLUTION;TOPICAL	Prescription

PENNSAID family patents

4. Pennsaid patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8741956	NUVO PHARMS INC	Treatment of pain with topical diclofenac	Jul, 2029 (5 years from now)
US8618164	NUVO PHARMS INC	Treatment of pain with topical diclofenac compounds	Jul, 2029 (5 years from now)
US8217078	NUVO PHARMS INC	Treatment of pain with topical diclofenac	Jul, 2029 (5 years from now)
US8546450	NUVO PHARMS INC	Treatment of pain with topical diclofenac compounds	Aug, 2030 (6 years from now)

Drug Exclusivity	Drug Exclusivity Expiration
New Dosage Form(NDF)	Nov 04, 2012

Market Authorisation Date: 04 November, 2009

Treatment: Combination use of topical diclofenac on the knee and administration of an oral nsaid.; Use of topical diclofenac on the knee and a second topical prescription medication on the same knee; Use of topi...

Dosage: SOLUTION;TOPICAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.015	11 Jul, 2012	1	27 May, 2014	10 Jul, 2029	Eligible
0.02	03 Jun, 2014	1		09 Aug, 2030	Extinguished

Strength	Dosage	Availability
1.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION;TOPICAL	Discontinued

PENNSAID family patents

5. Solaraze patents expiration

Drug Patent Number	Company	Drug Patent Title	Drug Patent Expiry
These drug patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5929048	FOUGERA PHARMS	Treatment of conditions and disease	Jun, 2014 (9 years ago)
US5639738	FOUGERA PHARMS	Treatment of basal cell carcinoma and actinic keratosis employing hyaluronic acid and NSAIDs	Jun, 2014 (9 years ago)
US5852002	FOUGERA PHARMS	Treatment of conditions and disease	Jun, 2014 (9 years ago)
US5792753	FOUGERA PHARMS	Compositions comprising hyaluronic acid and prostaglandin-synthesis-inhibiting drugs	Aug, 2015 (8 years ago)
US5985850	FOUGERA PHARMS	Compositions comprising hyaluronic acid and drugs	Aug, 2015 (8 years ago)
US5914322	FOUGERA PHARMS	Treatment of disease and conditions	Aug, 2015 (8 years ago)

Market Authorisation Date: 16 October, 2000

Treatment: Treatment of actinic keratoses

Dosage: GEL;TOPICAL

Pharsight

Drugs that contain Diclofenac Sodium

1. Diclofenac Sodium patents expiration

DICLOFENAC SODIUM family patents

2. Dyloject patents expiration

DYLOJECT family patents

3. Pennsaid patents expiration

PENNSAID family patents

4. Pennsaid patents expiration

PENNSAID family patents

5. Solaraze patents expiration

SOLARAZE family patents

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