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Last Updated: March 19, 2024

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 Chiesi, Fresenius Kabi Usa, Gland Pharma Ltd, Heritage Pharms, Meitheal, Sagent Pharms Inc, Sun Pharm Inds, Teva Pharms Usa Inc, West-ward Pharms Int, Wockhardt Usa, Mylan Institutional, and Novartis, and is included in twenty-four NDAs. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are nineteen drug master file entries for octreotide acetate. Ten suppliers are listed for this compound.

Summary for octreotide acetate
Drug Prices for octreotide acetate

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Recent Clinical Trials for octreotide acetate

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

SponsorPhase
Columbia UniversityPhase 1
Albert Einstein College of MedicinePhase 1
Debiopharm International SAPhase 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 Strength NDA ANDAs Submitted Submissiondate
MYCAPSSA Delayed-release Capsules octreotide acetate 20 mg 208232 1 2023-12-29
SANDOSTATIN Injection octreotide acetate 0.05 mg/mL (base), 0.1 mg/mL (base) and 0.5 mg/mL (base) packaged in 1 mL pre-filled syringes (preservative-free) 019667 1 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
Novartis SANDOSTATIN octreotide acetate INJECTABLE;INJECTION 019667-001 Oct 21, 1988 AP RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Teva Pharms Usa Inc OCTREOTIDE ACETATE octreotide acetate INJECTABLE;INJECTION 210317-001 Dec 5, 2023 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sagent Pharms Inc OCTREOTIDE ACETATE octreotide acetate INJECTABLE;INJECTION 091041-001 Nov 12, 2013 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fresenius Kabi Usa OCTREOTIDE ACETATE (PRESERVATIVE FREE) octreotide acetate INJECTABLE;INJECTION 077457-002 Feb 10, 2006 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Chiesi MYCAPSSA octreotide acetate CAPSULE, DELAYED RELEASE;ORAL 208232-001 Jun 26, 2020 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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 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 ⤷  Try a Trial ⤷  Try a Trial
Novartis SANDOSTATIN LAR octreotide acetate INJECTABLE;INJECTION 021008-002 Nov 25, 1998 ⤷  Try a Trial ⤷  Try a Trial
Novartis SANDOSTATIN LAR octreotide acetate INJECTABLE;INJECTION 021008-003 Nov 25, 1998 ⤷  Try a Trial ⤷  Try a Trial
Novartis SANDOSTATIN octreotide acetate INJECTABLE;INJECTION 019667-001 Oct 21, 1988 ⤷  Try a Trial ⤷  Try a Trial
Novartis SANDOSTATIN LAR octreotide acetate INJECTABLE;INJECTION 021008-002 Nov 25, 1998 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for octreotide acetate

Country Patent Number Title Estimated Expiration
United Kingdom 0916349 ⤷  Try a Trial
Japan 5623406 ⤷  Try a Trial
Mexico 2011002836 COMPOSICIONES FARMACEÚTICAS Y MÉTODOS DE ADMINISTRACIÓN RELACIONADOS. (PHARMACEUTICAL COMPOSITIONS AND RELATED METHODS OF DELIVERY.) ⤷  Try a Trial
Israel 276157 תכשירי רוקחות ושיטות להעברתם הקשורות להן (Pharmaceutical compositions and related methods of delivery) ⤷  Try a Trial
Denmark 2343982 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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