Irinotecan hydrochloride - Generic Drug Details
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What are the generic sources for irinotecan hydrochloride and what is the scope of freedom to operate?
Irinotecan hydrochloride
is the generic ingredient in three branded drugs marketed by Ipsen, Pfizer Inc, Accord Hlthcare, Actavis Totowa, Chartwell Rx, Cipla Ltd, Emcure Pharms Ltd, Epic Pharma Llc, Eugia Pharma, Fresenius Kabi Usa, Gland Pharma Ltd, Hengrui Pharma, Hikma Farmaceutica, Hisun Pharm Hangzhou, Hospira, Intas Pharms Usa, Novast Labs, Pliva Lachema, Qilu Pharm Hainan, Sandoz, Shilpa, Sun Pharma Global, Teva Pharms Usa, West-ward Pharms Int, and Zennova, and is included in twenty-eight NDAs. There are seventeen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Irinotecan hydrochloride has one hundred and twenty-three patent family members in twenty-eight countries.
There are thirty drug master file entries for irinotecan hydrochloride. Sixteen suppliers are listed for this compound.
Summary for irinotecan hydrochloride
International Patents: | 123 |
US Patents: | 17 |
Tradenames: | 3 |
Applicants: | 25 |
NDAs: | 28 |
Drug Master File Entries: | 30 |
Finished Product Suppliers / Packagers: | 16 |
Raw Ingredient (Bulk) Api Vendors: | 97 |
Clinical Trials: | 1,505 |
Patent Applications: | 6,975 |
Formulation / Manufacturing: | see details |
What excipients (inactive ingredients) are in irinotecan hydrochloride? | irinotecan hydrochloride excipients list |
DailyMed Link: | irinotecan hydrochloride at DailyMed |
Recent Clinical Trials for irinotecan hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
ECOG-ACRIN Cancer Research Group | Phase 3 |
Mirati Therapeutics | Phase 1 |
MEI Pharma, Inc. | Phase 1 |
Pharmacology for irinotecan hydrochloride
Drug Class | Topoisomerase Inhibitor |
Mechanism of Action | Topoisomerase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for irinotecan hydrochloride
Paragraph IV (Patent) Challenges for IRINOTECAN HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
CAMPTOSAR | Injection | irinotecan hydrochloride | 20 mg/mL, 2 mL and 5 mL vials | 020571 | 1 | 2004-07-26 |
US Patents and Regulatory Information for irinotecan hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Intas Pharms Usa | IRINOTECAN HYDROCHLORIDE | irinotecan hydrochloride | INJECTABLE;INJECTION | 203054-001 | Aug 31, 2017 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Ipsen | ONIVYDE | irinotecan hydrochloride | INJECTABLE, LIPOSOMAL;INTRAVENOUS | 207793-001 | Oct 22, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Hospira | IRINOTECAN HYDROCHLORIDE | irinotecan hydrochloride | INJECTABLE;INJECTION | 077915-002 | Feb 27, 2008 | AP | RX | No | 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 irinotecan hydrochloride
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Pfizer Inc | CAMPTOSAR | irinotecan hydrochloride | INJECTABLE;INJECTION | 020571-001 | Jun 14, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
Pfizer Inc | CAMPTOSAR | irinotecan hydrochloride | INJECTABLE;INJECTION | 020571-002 | Jun 14, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
Pfizer Inc | CAMPTOSAR | irinotecan hydrochloride | INJECTABLE;INJECTION | 020571-002 | Jun 14, 1996 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for irinotecan hydrochloride
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Spain | 2616047 | ⤷ Try a Trial | |
Taiwan | 201831168 | Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan | ⤷ Try a Trial |
Israel | 287571 | ייצוב תכשירי רוקחות של קמפטותצין (Stabilizing camptothecin pharmaceutical compositions) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for irinotecan hydrochloride
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1746976 | C01746976/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: IRINOTECAN SUCROSOFAT; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 65994 25.07.2017 |
1746976 | 2017/029 | Ireland | ⤷ Try a Trial | PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT; REGISTRATION NO/DATE: EU/1/16/1130 20161014 |
1746976 | CA 2017 00030 | Denmark | ⤷ Try a Trial | PRODUCT NAME: IRINOTECAN SUCROSOFATE SALT, SUCH AS IRINOTECAN SUCROSOFATE SALT IN A PEGYLATED LIPOSOME, SUCH AS A LIPOSOME COMPRISING 1,2-DISTEAROYL-SN-PHOSPHATIDYLCHOLINE, CHOLESTEROL AND N-(OMEGA-METHOXY-POLY(ETHYLENE GLYCOL)...; REG. NO/DATE: EU/1 /16/1130 20161018 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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