NAPROSYN Drug Patent Profile
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When do Naprosyn patents expire, and when can generic versions of Naprosyn launch?
Naprosyn is a drug marketed by Atnahs Pharma Us and is included in two NDAs.
The generic ingredient in NAPROSYN is naproxen. There are forty-two drug master file entries for this compound. Fifty-six suppliers are listed for this compound. Additional details are available on the naproxen profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Naprosyn
A generic version of NAPROSYN was approved as naproxen by GRANULES on December 21st, 1993.
Summary for NAPROSYN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 135 |
| Clinical Trials: | 44 |
| Patent Applications: | 2,141 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for NAPROSYN |
| What excipients (inactive ingredients) are in NAPROSYN? | NAPROSYN excipients list |
| DailyMed Link: | NAPROSYN at DailyMed |
Recent Clinical Trials for NAPROSYN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Northwestern Medical Group | Phase 2 |
| Shirley Ryan AbilityLab | Phase 2 |
| Western University, Canada | N/A |
Pharmacology for NAPROSYN
| Drug Class | Nonsteroidal Anti-inflammatory Drug |
| Mechanism of Action | Cyclooxygenase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for NAPROSYN
US Patents and Regulatory Information for NAPROSYN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Atnahs Pharma Us | NAPROSYN | naproxen | SUSPENSION;ORAL | 018965-001 | Mar 23, 1987 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Atnahs Pharma Us | NAPROSYN | naproxen | TABLET;ORAL | 017581-004 | Apr 15, 1982 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Atnahs Pharma Us | NAPROSYN | naproxen | TABLET;ORAL | 017581-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Atnahs Pharma Us | NAPROSYN | naproxen | TABLET;ORAL | 017581-003 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a 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 NAPROSYN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Atnahs Pharma Us | NAPROSYN | naproxen | TABLET;ORAL | 017581-004 | Apr 15, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
| Atnahs Pharma Us | NAPROSYN | naproxen | TABLET;ORAL | 017581-002 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
| Atnahs Pharma Us | NAPROSYN | naproxen | TABLET;ORAL | 017581-004 | Apr 15, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
| Atnahs Pharma Us | NAPROSYN | naproxen | SUSPENSION;ORAL | 018965-001 | Mar 23, 1987 | ⤷ Try a Trial | ⤷ Try a Trial |
| Atnahs Pharma Us | NAPROSYN | naproxen | TABLET;ORAL | 017581-004 | Apr 15, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NAPROSYN
See the table below for patents covering NAPROSYN around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Germany | 1768886 | ⤷ Try a Trial | |
| Spain | 410164 | ⤷ Try a Trial | |
| Belgium | 747812 | ⤷ Try a Trial | |
| United Kingdom | 1301455 | ⤷ Try a Trial | |
| Netherlands | 7004194 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NAPROSYN
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0984957 | CR 2012 00035 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ET KOMBINATIONSPRODUKT AF NAPROXEN OG ESOMEPRAZOL MAGNESIUM TRIHYDRAT; NAT. REG. NO/DATE: 49583 20120327; FIRST REG. NO/DATE: GB PL 17901/0263-001 20101105 |
| 0984957 | PA2011005,C0984957 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126 |
| 1411900 | 2011/016 | Ireland | ⤷ Try a Trial | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE MODIFIED-RELEASE TABLETS; NAT REGISTRATION NO/DATE: PA0970/060/001 20101221; FIRST REGISTRATION NO/DATE: PL17901/0263-0001 20101105 |
| 1411900 | 122012000052 | Germany | ⤷ Try a Trial | PRODUCT NAME: NAPROXEN MIT ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105 |
| 1411900 | SPC/GB11/015 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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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