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Last Updated: March 29, 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
Gland Pharma Ltd OCTREOTIDE ACETATE octreotide acetate INJECTABLE;INJECTION 216839-002 Jun 22, 2023 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm Inds OCTREOTIDE ACETATE octreotide acetate INJECTABLE;INJECTION 077372-002 Aug 14, 2007 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Heritage Pharms OCTREOTIDE ACETATE octreotide acetate INJECTABLE;INJECTION 204669-002 Dec 27, 2018 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Meitheal OCTREOTIDE ACETATE octreotide acetate INJECTABLE;INJECTION 075959-002 Nov 21, 2005 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 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 ⤷  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 021008-001 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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