NAPRELAN Drug Patent Profile
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When do Naprelan patents expire, and what generic alternatives are available?
Naprelan is a drug marketed by Twi Pharms and is included in one NDA.
The generic ingredient in NAPRELAN is naproxen sodium. There are forty-two drug master file entries for this compound. One hundred and thirty-five suppliers are listed for this compound. Additional details are available on the naproxen sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Naprelan
A generic version of NAPRELAN was approved as naproxen sodium by CONTRACT PHARMACAL on January 13th, 1997.
Summary for NAPRELAN
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 93 |
Clinical Trials: | 8 |
Patent Applications: | 6,228 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for NAPRELAN |
Drug Sales Revenues: | Drug sales revenues for NAPRELAN |
What excipients (inactive ingredients) are in NAPRELAN? | NAPRELAN excipients list |
DailyMed Link: | NAPRELAN at DailyMed |
Recent Clinical Trials for NAPRELAN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Northwestern Medical Group | Phase 2 |
Apkar Apkarian | Phase 4 |
National Institutes of Health (NIH) | Phase 4 |
Pharmacology for NAPRELAN
Drug Class | Nonsteroidal Anti-inflammatory Drug |
Mechanism of Action | Cyclooxygenase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for NAPRELAN
US Patents and Regulatory Information for NAPRELAN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Twi Pharms | NAPRELAN | naproxen sodium | TABLET, EXTENDED RELEASE;ORAL | 020353-001 | Jan 5, 1996 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Twi Pharms | NAPRELAN | naproxen sodium | TABLET, EXTENDED RELEASE;ORAL | 020353-002 | Jan 5, 1996 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Twi Pharms | NAPRELAN | naproxen sodium | TABLET, EXTENDED RELEASE;ORAL | 020353-003 | Jan 5, 1996 | AB | RX | Yes | Yes | ⤷ 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 NAPRELAN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Twi Pharms | NAPRELAN | naproxen sodium | TABLET, EXTENDED RELEASE;ORAL | 020353-003 | Jan 5, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
Twi Pharms | NAPRELAN | naproxen sodium | TABLET, EXTENDED RELEASE;ORAL | 020353-001 | Jan 5, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
Twi Pharms | NAPRELAN | naproxen sodium | TABLET, EXTENDED RELEASE;ORAL | 020353-002 | Jan 5, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for NAPRELAN
See the table below for patents covering NAPRELAN around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Ireland | 66933 | Controlled absorption naproxen formulation for once-daily administration | ⤷ Try a Trial |
Ireland | 900149 | ⤷ Try a Trial | |
South Africa | 9100274 | ⤷ Try a Trial | |
Australia | 639519 | ⤷ Try a Trial | |
New Zealand | 236762 | ORAL NAPROXEN FORMULATION | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for NAPRELAN
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0984957 | SPC/GB11/013 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105 |
1411900 | C300481 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: NAPROXEN EN ESOMEPRAZOL; NAT. REGISTRATION NO/DATE: RVG 106235 20101118; FIRST REGISTRATION: PL 17901/0263-001 20101105 |
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 | 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 | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |