PATANASE Drug Patent Profile
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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-three 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 8th, 2014.
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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 |
| 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 |
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 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 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 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | PATANASE | olopatadine hydrochloride | SPRAY, METERED;NASAL | 021861-001 | Apr 15, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| Novartis | PATANASE | olopatadine hydrochloride | SPRAY, METERED;NASAL | 021861-001 | Apr 15, 2008 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PATANASE
See the table below for patents covering PATANASE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Austria | 295149 | ⤷ Sign Up | |
| Brazil | 0210707 | ⤷ Sign Up | |
| Japan | 2012107046 | OLOPATADINE FORMULATION FOR TOPICAL ADMINISTRATION | ⤷ Sign Up |
| South Korea | 100884711 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for PATANASE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3043773 | 301154 | Netherlands | ⤷ Sign Up | 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 |
| 3043773 | 2022C/520 | Belgium | ⤷ Sign Up | PRODUCT NAME: MOMETASONE OF EEN ZOUT HIERVAN EN OLOPATADINE OF EEN ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: BE595626 20220203 |
| 0799044 | 02C0040 | France | ⤷ Sign Up | PRODUCT NAME: OLOPATADINE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/02/217/001 20020517 |
| 3043773 | 2190041-0 | Sweden | ⤷ Sign Up | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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