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Last Updated: August 4, 2020

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OCTREOTIDE ACETATE - Generic Drug Details

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What are the generic sources for octreotide acetate and what is the scope of patent protection?

Octreotide acetate is the generic ingredient in six branded drugs marketed by 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-one NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Octreotide acetate has five patent family members in five countries.

There are twenty drug master file entries for octreotide acetate. Eight 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
Roswell Park Cancer InstitutePhase 1
NeuroEndocrine Tumor Research Foundation (NETRF)Phase 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
Wockhardt Usa OCTREOTIDE ACETATE PRESERVATIVE FREE octreotide acetate INJECTABLE;INJECTION 090985-002 May 11, 2011 DISCN No No   Start Trial   Start Trial   Start Trial
Wockhardt Usa OCTREOTIDE ACETATE octreotide acetate INJECTABLE;INJECTION 090986-001 May 11, 2011 DISCN No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa OCTREOTIDE ACETATE (PRESERVATIVE FREE) octreotide acetate INJECTABLE;INJECTION 077457-001 Feb 10, 2006 AP RX 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
>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 LAR octreotide acetate INJECTABLE;INJECTION 021008-001 Nov 25, 1998   Start Trial   Start Trial
Novartis SANDOSTATIN LAR octreotide acetate INJECTABLE;INJECTION 021008-001 Nov 25, 1998   Start Trial   Start Trial
Novartis SANDOSTATIN octreotide acetate INJECTABLE;INJECTION 019667-004 Jun 12, 1991   Start Trial   Start Trial
Novartis SANDOSTATIN LAR octreotide acetate INJECTABLE;INJECTION 021008-002 Nov 25, 1998   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:

Mallinckrodt
Express Scripts
Harvard Business School
Medtronic
Boehringer Ingelheim
Colorcon

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