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Indomethacin - Generic Drug Details
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What are the generic drug sources for indomethacin and what is the scope of freedom to operate?
Indomethacin
is the generic ingredient in six branded drugs marketed by Egalet, Able, Amneal Pharms, Aurobindo Pharma Ltd, Avanthi Inc, Chartwell Rx, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Inwood Labs, Jubilant Generics, Mylan, Novast Labs, Sandoz, Watson Labs Inc, Zydus Pharms, Teva, Ani Pharms Inc, Cadila, Chartwell Molecules, Cycle Pharms Ltd, Duramed Pharms Barr, Glenmark Generics, Halsey, Heritage, Heritage Pharma, Ivax Sub Teva Pharms, Mutual Pharm, Parke Davis, Pioneer Pharms, Sun Pharm Inds Inc, Sun Pharm Industries, Superpharm, Watson Labs, Genus, Fresenius Kabi Usa, Cosette, Hikma, Recordati Rare, Hospira Inc, Navinta Llc, and West-ward Pharms Int, and is included in seventy NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.Indomethacin has thirty-seven patent family members in twenty-one countries.
There are fifteen drug master file entries for indomethacin. Thirty suppliers are listed for this compound.
Summary for indomethacin
International Patents: | 37 |
US Patents: | 3 |
Tradenames: | 6 |
Applicants: | 41 |
NDAs: | 70 |
Drug Master File Entries: | 15 |
Suppliers / Packagers: | 30 |
Bulk Api Vendors: | 143 |
Clinical Trials: | 147 |
Patent Applications: | 6,947 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for indomethacin |
Drug Sales Revenues: | Drug sales revenues for indomethacin |
DailyMed Link: | indomethacin at DailyMed |
Recent Clinical Trials for indomethacin
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Laval University | Phase 3 |
CHU de Quebec-Universite Laval | Phase 3 |
Woman's | N/A |
Pharmacology for indomethacin
Drug Class | Nonsteroidal Anti-inflammatory Drug |
Mechanism of Action | Cyclooxygenase Inhibitors |
Medical Subject Heading (MeSH) Categories for indomethacin
Paragraph IV (Patent) Challenges for INDOMETHACIN
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
INDOCIN SR | CAPSULE, EXTENDED RELEASE;ORAL | indomethacin | 018185 |
US Patents and Regulatory Information for indomethacin
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Egalet | INDOCIN | indomethacin | SUSPENSION;ORAL | 018332-001 | Oct 10, 1985 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Hetero Labs Ltd Iii | INDOMETHACIN | indomethacin | CAPSULE;ORAL | 091240-001 | Apr 12, 2011 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
Mylan | INDOMETHACIN | indomethacin | CAPSULE;ORAL | 018858-001 | Apr 20, 1984 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Superpharm | INDOMETHACIN | indomethacin | CAPSULE;ORAL | 070488-001 | Oct 10, 1986 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Watson Labs | INDOMETHACIN | indomethacin | CAPSULE;ORAL | 070785-001 | Aug 20, 1986 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
Teva | INDO-LEMMON | indomethacin | CAPSULE;ORAL | 070266-001 | Nov 7, 1985 | DISCN | No | No | Start Trial | Start Trial | Start 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 indomethacin
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Egalet | INDOCIN SR | indomethacin | CAPSULE, EXTENDED RELEASE;ORAL | 018185-001 | Feb 23, 1982 | Start Trial | Start Trial |
Egalet | INDOCIN | indomethacin | SUPPOSITORY;RECTAL | 017814-001 | Aug 13, 1984 | Start Trial | Start Trial |
Egalet | INDOCIN | indomethacin | SUPPOSITORY;RECTAL | 017814-001 | Aug 13, 1984 | Start Trial | Start Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for indomethacin
Country | Patent Number | Estimated Expiration |
---|---|---|
Singapore | 10201401695V | Start Trial |
Denmark | 2421513 | Start Trial |
China | 102438594 | Start Trial |
Israel | 215872 | Start Trial |
New Zealand | 595986 | Start Trial |
Japan | 2012524724 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
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