PATANASE Drug Patent Profile

Which patents cover Patanase, and when can generic versions of Patanase launch?

Patanase is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in PATANASE is olopatadine hydrochloride. There are seventeen drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the olopatadine hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Patanase

A generic version of PATANASE was approved as olopatadine hydrochloride by APOTEX INC on October 8^th, 2014.

Summary for PATANASE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	93
Clinical Trials:	4
Patent Applications:	1,088
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for PATANASE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PATANASE
What excipients (inactive ingredients) are in PATANASE?	PATANASE excipients list
DailyMed Link:	PATANASE at DailyMed

See drug prices for PATANASE

See drug sales revenues for PATANASE

Recent Clinical Trials for PATANASE

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

Sponsor	Phase
Glenmark Pharmaceuticals Ltd. India	Phase 2
Alcon Research	Phase 4
Alcon Research	Phase 2

See all PATANASE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for PATANASE

R01AC	Antiallergic agents, excl. corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

S01GX	Other antiallergics
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

Paragraph IV (Patent) Challenges for PATANASE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
PATANASE	Nasal Spray	olopatadine hydrochloride	0.665 mg/ Spray	021861	1	2009-06-29

US Patents and Regulatory Information for PATANASE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	PATANASE	olopatadine hydrochloride	SPRAY, METERED;NASAL	021861-001	Apr 15, 2008		DISCN	Yes	No

Expired US Patents for PATANASE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	PATANASE	olopatadine hydrochloride	SPRAY, METERED;NASAL	021861-001	Apr 15, 2008
Novartis	PATANASE	olopatadine hydrochloride	SPRAY, METERED;NASAL	021861-001	Apr 15, 2008
Novartis	PATANASE	olopatadine hydrochloride	SPRAY, METERED;NASAL	021861-001	Apr 15, 2008

International Patents for PATANASE

See the table below for patents covering PATANASE around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	2004536096
Japan	4827374
Poland	367780
Japan	S6310784	DIBENZ(B,E)OXEPIN DERIVATIVE, ANTIALLERGIC AGENT AND ANTI-INFLAMMATORY AGENT
Mexico	9203155	DERIVADO [B,E] OXEPINA COMO AGENTE ANTIALERGICO.

Supplementary Protection Certificates for PATANASE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3043773	21C1057	France		PRODUCT NAME: MOMETASONE OU L'UN DE SES SELS AVEC OLOPATADINE OU L'UN DE SES SELS; NAT. REGISTRATION NO/DATE: NL52121 20211026; FIRST REGISTRATION: AT - 140638 20210426
0799044	02C0040	France		PRODUCT NAME: OLOPATADINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/02/217/001 20020517
3043773	2022C/520	Belgium		PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203
3043773	2190041-0	Sweden		PRODUCT NAME: MOMETASONE OR A SALT THEREOF AND OLOPATADINE OR A SALT THEREOF; NAT. REG. NO/DATE: MT NR 60226 20210519; FIRST REG.: AT APPROVAL NR 140638 20210426
3043773	301154	Netherlands		PRODUCT NAME: MOMETASON OF EEN ZOUT DAARVAN EN OLOPATADINE OF EEN ZOUT DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 126186 20211014; FIRST REGISTRATION: AT 140638 20210426