INDOCIN Drug Patent Profile
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Which patents cover Indocin, and what generic alternatives are available?
Indocin is a drug marketed by Zyla Life Sciences, Recordati Rare, and Zyla. and is included in five NDAs.
The generic ingredient in INDOCIN is indomethacin sodium. There are fifteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the indomethacin sodium profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Indocin
A generic version of INDOCIN was approved as indomethacin sodium by WEST-WARD PHARMS INT on July 16th, 2008.
Summary for INDOCIN
US Patents: | 0 |
Applicants: | 3 |
NDAs: | 5 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 164 |
Clinical Trials: | 22 |
Patent Applications: | 4,407 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for INDOCIN |
What excipients (inactive ingredients) are in INDOCIN? | INDOCIN excipients list |
DailyMed Link: | INDOCIN at DailyMed |
Recent Clinical Trials for INDOCIN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Johns Hopkins University | Phase 3 |
MetroHealth Medical Center | Early Phase 1 |
University of Washington | Phase 2 |
Pharmacology for INDOCIN
Drug Class | Nonsteroidal Anti-inflammatory Drug |
Mechanism of Action | Cyclooxygenase Inhibitors |
US Patents and Regulatory Information for INDOCIN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Zyla Life Sciences | INDOCIN | indomethacin | CAPSULE;ORAL | 016059-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Zyla Life Sciences | INDOCIN | indomethacin | SUPPOSITORY;RECTAL | 017814-001 | Aug 13, 1984 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Zyla Life Sciences | INDOCIN | indomethacin | CAPSULE;ORAL | 016059-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Recordati Rare | INDOCIN | indomethacin sodium | INJECTABLE;INJECTION | 018878-001 | Jan 30, 1985 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Zyla | INDOCIN SR | indomethacin | CAPSULE, EXTENDED RELEASE;ORAL | 018185-001 | Feb 23, 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 INDOCIN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Zyla Life Sciences | INDOCIN | indomethacin | SUPPOSITORY;RECTAL | 017814-001 | Aug 13, 1984 | ⤷ Try a Trial | ⤷ Try a Trial |
Zyla Life Sciences | INDOCIN | indomethacin | SUPPOSITORY;RECTAL | 017814-001 | Aug 13, 1984 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for INDOCIN
See the table below for patents covering INDOCIN around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Germany | 2248777 | ⤷ Try a Trial | |
Sweden | 384134 | FORFARANDE VID FRAMSTELLNING AV INDOMETACIN INNEHALLANDE SUPPOSITORIER | ⤷ Try a Trial |
Australia | 472229 | ⤷ Try a Trial | |
Finland | 50832 | ⤷ Try a Trial | |
South Africa | 7006715 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |