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 | SUSPENSION;ORAL | 018965-001 | Mar 23, 1987 | ⤷ 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 | 017581-002 | Approved Prior to Jan 1, 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 | 017581-003 | Approved Prior to Jan 1, 1982 | ⤷ Try a Trial | ⤷ Try a Trial |
Atnahs Pharma Us | NAPROSYN | naproxen | TABLET;ORAL | 017581-003 | Approved Prior to Jan 1, 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 |
---|---|---|---|
Japan | S516667 | ⤷ Try a Trial | |
Canada | 983517 | PREPARATION OF 2-(6-METHOXY-2-NAPHTHYL) PROPIONIC ACID | ⤷ Try a Trial |
United Kingdom | 1301439 | ⤷ Try a Trial | |
Germany | 1932389 | ⤷ Try a Trial | |
Finland | 66344 | ⤷ Try a Trial | |
Netherlands | 7512107 | ⤷ 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 |
---|---|---|---|---|
1411900 | 2011C/016 | Belgium | ⤷ Try a Trial | PRODUCT NAME: NAPROXENE ET ESOMEPRAZOLE (SOUS LA FORME D'ESOMEPRAZOLE MAGNESIUM TRIHYDRATE); AUTHORISATION NUMBER AND DATE: BE382505 20101214 |
1411900 | SPC/GB11/015 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
1411900 | 18/2011 | Austria | ⤷ Try a Trial | PRODUCT NAME: NAPROXEN UND ESOMEPRAZOL SOWIE DEREN PHARMAZEUTISCH ANNEHMBARE SALZE; NAT. REGISTRATION NO/DATE: 1-29937 20110105; FIRST REGISTRATION: GB PL 17901/0263-0001 20101105 |
0984957 | PA2011005 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: NAPROXENUM + ESOMEPRAZOLUM; REGISTRATION NO/DATE: LT/1/10/2302/001-LT/1/10/2302/012 20110126 |
1411900 | 1190013-1 | Sweden | ⤷ Try a Trial | PRODUCT NAME: NAPROXEN OCH ESOMEPRAZOL; NAT. REG. NO/DATE: MTNR 43248 20101203; FIRST REG.: GB PL 17901/0263 20101105 |
0984957 | 122012000051 | Germany | ⤷ Try a Trial | PRODUCT NAME: KOMBINATIONSPRODUKT UMFASSEND NAPROXEN UND ESOMEPRAZOL-MAGNESIUM-TRIHYDRAT; NAT. REGISTRATION NO/DATE: 85145.00.00 20120202; FIRST REGISTRATION: GROSSBRITANNIEN PL 17901/0263 - 0001 20101105 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |