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Last Updated: October 1, 2020

DrugPatentWatch Database Preview

Octreotide acetate - Generic Drug Details

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What are the generic drug sources for octreotide acetate and what is the scope of freedom to operate?

Octreotide acetate is the generic ingredient in seven branded drugs marketed by Chiasma, Fresenius Kabi Usa, Heritage Pharms Inc, Sagent Pharms Inc, Sun Pharm Inds, Teva Pharms Usa, West-ward Pharms Int, Wockhardt Usa, Mylan Institutional, Novartis, and Sun Pharm, and is included in twenty-two NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Octreotide acetate has fifty-nine patent family members in twenty-four countries.

There are twenty drug master file entries for octreotide acetate. Nine suppliers are listed for this compound.

Drug Prices for octreotide acetate

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Recent Clinical Trials for octreotide acetate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
NeuroEndocrine Tumor Research Foundation (NETRF)Phase 1
Roswell Park Cancer InstitutePhase 1
Ono Pharmaceutical Co. LtdPhase 1

See all octreotide acetate clinical trials

Pharmacology for octreotide acetate
Medical Subject Heading (MeSH) Categories for octreotide acetate
Paragraph IV (Patent) Challenges for OCTREOTIDE ACETATE
Tradename Dosage Ingredient NDA Submissiondate
SANDOSTATIN INJECTABLE;INJECTION octreotide acetate 019667 2008-01-17

US Patents and Regulatory Information for octreotide acetate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Institutional OCTREOTIDE ACETATE (PRESERVATIVE FREE) octreotide acetate INJECTABLE;INJECTION 079198-002 Feb 10, 2011 AP RX No No   Start Trial   Start Trial   Start Trial
Wockhardt Usa OCTREOTIDE ACETATE PRESERVATIVE FREE octreotide acetate INJECTABLE;INJECTION 090985-001 May 11, 2011 DISCN No No   Start Trial   Start Trial   Start Trial
Heritage Pharms Inc OCTREOTIDE ACETATE octreotide acetate INJECTABLE;INJECTION 203765-001 Sep 7, 2018 DISCN No No   Start Trial   Start Trial   Start Trial
Sun Pharm Inds OCTREOTIDE ACETATE octreotide acetate INJECTABLE;INJECTION 077329-003 Mar 4, 2008 DISCN No No   Start Trial   Start Trial   Start Trial
Sun Pharm Inds OCTREOTIDE ACETATE octreotide acetate INJECTABLE;INJECTION 077372-001 Aug 14, 2007 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 octreotide acetate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis SANDOSTATIN octreotide acetate INJECTABLE;INJECTION 019667-003 Oct 21, 1988   Start Trial   Start Trial
Novartis SANDOSTATIN LAR octreotide acetate INJECTABLE;INJECTION 021008-003 Nov 25, 1998   Start Trial   Start Trial
Novartis SANDOSTATIN LAR octreotide acetate INJECTABLE;INJECTION 021008-003 Nov 25, 1998   Start Trial   Start Trial
Novartis SANDOSTATIN LAR octreotide acetate INJECTABLE;INJECTION 021008-002 Nov 25, 1998   Start Trial   Start Trial
Novartis SANDOSTATIN octreotide acetate INJECTABLE;INJECTION 019667-002 Oct 21, 1988   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Colorcon
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Express Scripts
Medtronic
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Johnson and Johnson

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