Is there a generic for Octreotide acetate?

Yes. The FDA Orange Book lists 23 approved generic (ANDA) applications for Octreotide acetate, referencing the brand BYNFEZIA PEN. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Octreotide acetate?

BYNFEZIA PEN (NDA 213224, SUN PHARM) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Octreotide acetate?

The Orange Book lists 21 patents against Octreotide acetate products, with the earliest listed expiry in 2029. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Does Octreotide acetate have FDA marketing exclusivity?

Yes. The Orange Book records 4 marketing-exclusivity periods for Octreotide acetate. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Octreotide acetate are approved?

Octreotide acetate is approved in the following dosage forms: capsule, delayed release, injectable, solution.

FDA Orange Book · active-ingredient family

Octreotide acetate

Octreotide acetate is approved as 4 brand and 23 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:BYNFEZIA PEN · NDA 213224

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule, delayed release, injectable, solution

Product	Applicant	Application	TE	Approved
BYNFEZIA PENRLD	SUN PHARM	NDA 213224	—	Sep 27, 2024
MYCAPSSARLD	CHIESI	NDA 208232	—	Jun 26, 2020
SANDOSTATIN LARRLD×3	NOVARTIS	NDA 021008	AB	Nov 25, 1998
SANDOSTATINRLD×5	NOVARTIS	NDA 019667	AP	Oct 21, 1988

Generic (ANDA) products (23)

Product	Applicant	Application	TE	Approved
OCTREOTIDE ACETATE×3	MYLAN LABS LTD	ANDA 216589	AB	Dec 12, 2025
OCTREOTIDE ACETATE	SHUANGCHENG	ANDA 217860	—	May 02, 2024
OCTREOTIDE ACETATE×3	TEVA PHARMS USA INC	ANDA 210317	AB	Dec 05, 2023
OCTREOTIDE ACETATE×2	GLAND	ANDA 216839	AP	Jun 22, 2023
OCTREOTIDE ACETATE×2	GLAND	ANDA 216807	AP	Jun 13, 2023
OCTREOTIDE ACETATE×3	HERITAGE	ANDA 204669	AP	Dec 27, 2018
OCTREOTIDE ACETATE×2	HERITAGE	ANDA 203765	AP	Sep 07, 2018
OCTREOTIDE ACETATE×2	SAGENT PHARMS INC	ANDA 091041	AP	Nov 12, 2013
OCTREOTIDE ACETATE (PRESERVATIVE FREE)×3	SAGENT PHARMS INC	ANDA 090834	AP	Nov 12, 2013
OCTREOTIDE ACETATE×2	WOCKHARDT USA	ANDA 090986	—	May 11, 2011
OCTREOTIDE ACETATE PRESERVATIVE FREE×3	WOCKHARDT USA	ANDA 090985	—	May 11, 2011
OCTREOTIDE ACETATE (PRESERVATIVE FREE)×3	MYLAN INSTITUTIONAL	ANDA 079198	AP	Feb 10, 2011
OCTREOTIDE ACETATE×3	SUN PHARM INDS	ANDA 077329	—	Mar 04, 2008
OCTREOTIDE ACETATE	SUN PHARM INDS	ANDA 077330	—	Mar 04, 2008
OCTREOTIDE ACETATE	SUN PHARM INDS	ANDA 077331	—	Mar 04, 2008
OCTREOTIDE ACETATE×3	SUN PHARM INDS	ANDA 077372	—	Aug 14, 2007
OCTREOTIDE ACETATE×2	SUN PHARM INDS	ANDA 077373	—	Aug 14, 2007
OCTREOTIDE ACETATE×2	FRESENIUS KABI USA	ANDA 077450	AP	Feb 10, 2006
OCTREOTIDE ACETATE (PRESERVATIVE FREE)×3	FRESENIUS KABI USA	ANDA 077457	AP	Feb 10, 2006
OCTREOTIDE ACETATE×2	MEITHEAL	ANDA 075959	AP	Nov 21, 2005
OCTREOTIDE ACETATE×3	MEITHEAL	ANDA 075957	AP	Oct 03, 2005
OCTREOTIDE ACETATE×2	WEST-WARD PHARMS INT	ANDA 076330	AP	Apr 08, 2005
OCTREOTIDE ACETATE (PRESERVATIVE FREE)×3	WEST-WARD PHARMS INT	ANDA 076313	AP	Mar 28, 2005

Marketing exclusivity (4)

ODE-474Orphan-drug exclusivity (7 years)
Jun 26, 2027
in 1 yr
CGTFDA marketing exclusivity
Aug 02, 2026
in 1 mo
CGTFDA marketing exclusivity
Jul 27, 2026
in 1 mo
CGTFDA marketing exclusivity
Jul 27, 2026
in 1 mo

Listed patents (21)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8535695	Sep 17, 2029	in 3 yr 4 mo	U-2857
11986529	Sep 17, 2029	in 3 yr 4 mo	U-2857
11969471	Sep 17, 2029	in 3 yr 4 mo	Product
8329198	Sep 17, 2029	in 3 yr 4 mo	Product
9265812	Sep 17, 2029	in 3 yr 4 mo	Product
9566246	Sep 17, 2029	in 3 yr 4 mo	Product
11338011	Feb 03, 2036	in 9 yr 9 mo	U-2857
12251418	Feb 03, 2036	in 9 yr 9 mo	U-2857
12246054	Feb 03, 2036	in 9 yr 9 mo	U-2857
10695397	Feb 03, 2036	in 9 yr 9 mo	U-2857
10238709	Feb 03, 2036	in 9 yr 9 mo	U-2857
11510963	Feb 03, 2036	in 9 yr 9 mo	U-2857
11052126	Feb 03, 2036	in 9 yr 9 mo	U-2857
11857595	Feb 03, 2036	in 9 yr 9 mo	U-3784
10342850	May 15, 2038	in 12 yr 1 mo	Product
11246991	Nov 03, 2040	in 14 yr 7 mo	U-4007
11534553	Nov 03, 2040	in 14 yr 7 mo	U-4007
11052196	Nov 03, 2040	in 14 yr 7 mo	U-4007
11141457	Dec 28, 2040	in 14 yr 9 mo	U-3232
11890316	Dec 28, 2040	in 14 yr 9 mo	U-3232
12350475	Dec 29, 2041	in 15 yr 9 mo	U-4007

Octreotide acetate — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

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