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Last Updated: October 21, 2021

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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 six 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, and Novartis, and is included in twenty-one NDAs. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Octreotide acetate has sixty-one patent family members in twenty-five countries.

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

Summary for octreotide acetate
Drug Prices for octreotide acetate

See drug prices for octreotide acetate

Recent Clinical Trials for octreotide acetate

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

SponsorPhase
National Institute for Health Research, United KingdomPhase 2
University College, LondonPhase 2
NeuroEndocrine Tumor Research Foundation (NETRF)Phase 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
Chiasma MYCAPSSA octreotide acetate CAPSULE, DELAYED RELEASE;ORAL 208232-001 Jun 26, 2020 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Sagent Pharms Inc OCTREOTIDE ACETATE (PRESERVATIVE FREE) octreotide acetate INJECTABLE;INJECTION 090834-003 Nov 12, 2013 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Chiasma MYCAPSSA octreotide acetate CAPSULE, DELAYED RELEASE;ORAL 208232-001 Jun 26, 2020 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Sun Pharm Inds OCTREOTIDE ACETATE octreotide acetate INJECTABLE;INJECTION 077372-003 Aug 14, 2007 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Sagent Pharms Inc OCTREOTIDE ACETATE octreotide acetate INJECTABLE;INJECTION 091041-002 Nov 12, 2013 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Fresenius Kabi Usa OCTREOTIDE ACETATE (PRESERVATIVE FREE) octreotide acetate INJECTABLE;INJECTION 077457-003 Feb 10, 2006 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Fresenius Kabi Usa OCTREOTIDE ACETATE (PRESERVATIVE FREE) octreotide acetate INJECTABLE;INJECTION 077457-001 Feb 10, 2006 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 021008-003 Nov 25, 1998 ⤷  Try it Free ⤷  Try it Free
Novartis SANDOSTATIN octreotide acetate INJECTABLE;INJECTION 019667-002 Oct 21, 1988 ⤷  Try it Free ⤷  Try it Free
Novartis SANDOSTATIN LAR octreotide acetate INJECTABLE;INJECTION 021008-003 Nov 25, 1998 ⤷  Try it Free ⤷  Try it Free
Novartis SANDOSTATIN LAR octreotide acetate INJECTABLE;INJECTION 021008-001 Nov 25, 1998 ⤷  Try it Free ⤷  Try it Free
Novartis SANDOSTATIN LAR octreotide acetate INJECTABLE;INJECTION 021008-001 Nov 25, 1998 ⤷  Try it Free ⤷  Try it Free
Novartis SANDOSTATIN LAR octreotide acetate INJECTABLE;INJECTION 021008-001 Nov 25, 1998 ⤷  Try it Free ⤷  Try it Free
Novartis SANDOSTATIN LAR octreotide acetate INJECTABLE;INJECTION 021008-001 Nov 25, 1998 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Colorcon
Moodys
Express Scripts
Medtronic
AstraZeneca
Johnson and Johnson

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