MYCAPSSA Drug Patent Profile

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Which patents cover Mycapssa, and what generic alternatives are available?

Mycapssa is a drug marketed by Chiesi and is included in one NDA. There are fourteen patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-five patent family members in twenty-five countries.

The generic ingredient in MYCAPSSA is octreotide acetate. There are twenty drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the octreotide acetate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Mycapssa

A generic version of MYCAPSSA was approved as octreotide acetate by WEST-WARD PHARMS INT on April 8^th, 2005.

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Summary for MYCAPSSA

International Patents:	65
US Patents:	14
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	22
Clinical Trials:	2
Patent Applications:	774
Drug Prices:	Drug price information for MYCAPSSA
What excipients (inactive ingredients) are in MYCAPSSA?	MYCAPSSA excipients list
DailyMed Link:	MYCAPSSA at DailyMed

Drug patent expirations by year for MYCAPSSA

Recent Clinical Trials for MYCAPSSA

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

Sponsor	Phase
Chiasma, Inc.	Phase 3

See all MYCAPSSA clinical trials

Pharmacology for MYCAPSSA

Drug Class	Somatostatin Analog
Mechanism of Action	Somatostatin Receptor Agonists

Paragraph IV (Patent) Challenges for MYCAPSSA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
MYCAPSSA	Delayed-release Capsules	octreotide acetate	20 mg	208232	1	2023-12-29

US Patents and Regulatory Information for MYCAPSSA

MYCAPSSA is protected by fourteen US patents and one FDA Regulatory Exclusivity.

Patents protecting MYCAPSSA

Method of treating diseases
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Patented Use: USE OF ORAL OCTREOTIDE FOR LONG-TERM MAINTENANCE TREATMENT IN ACROMEGALY PATIENTS WHO HAVE RESPONDED TO AND TOLERATED TREATMENT WITH OCTREOTIDE OR LANREOTIDE

Oral octreotide therapy and contraceptive methods
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Patented Use: USE OF ORAL OCTREOTIDE FOR LONG-TERM MAINTENANCE TREATMENT IN ACROMEGALY PATIENTS WHILE AVOIDING CONCOMITANT ADMINISTRATION OF LEVONORGESTREL

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Patented Use: USE OF ORAL OCTREOTIDE IN COMBINATION WITH A H2-RECEPTOR ANTAGONIST OR ANTACID FOR LONG-TERM MAINTENANCE TREATMENT IN ACROMEGALY PATIENTS WHO HAVE RESPONDED TO AND TOLERATED TREATMENT WITH OCTREOTIDE OR LANREOTIDE

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Patented Use: USE OF ORAL OCTREOTIDE FOR LONG-TERM MAINTENANCE TREATMENT IN ACROMEGALY PATIENTS WHILE AVOIDING CONCOMITANT ADMINISTRATION OF LEVONORGESTREL

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Patented Use: USE OF ORAL OCTREOTIDE FOR LONG-TERM MAINTENANCE TREATMENT IN ACROMEGALY PATIENTS WHO HAVE RESPONDED TO AND TOLERATED TREATMENT WITH OCTREOTIDE OR LANREOTIDE

Pharmaceutical compositions and related methods of delivery
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Pharmaceutical compositions and related methods of delivery
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Patented Use: USE OF ORAL OCTREOTIDE FOR LONG-TERM MAINTENANCE TREATMENT IN ACROMEGALY PATIENTS WHO HAVE RESPONDED TO AND TOLERATED TREATMENT WITH OCTREOTIDE OR LANREOTIDE

Pharmaceutical compositions and related methods of delivery
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FDA Regulatory Exclusivity protecting MYCAPSSA

LONG-TERM MAINTENANCE TREATMENT IN ACROMEGALY PATIENTS WHO HAVE RESPONDED TO AND TOLERATED TREATMENT WITH OCTREOTIDE OR LANREOTIDE
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chiesi	MYCAPSSA	octreotide acetate	CAPSULE, DELAYED RELEASE;ORAL	208232-001	Jun 26, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chiesi	MYCAPSSA	octreotide acetate	CAPSULE, DELAYED RELEASE;ORAL	208232-001	Jun 26, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chiesi	MYCAPSSA	octreotide acetate	CAPSULE, DELAYED RELEASE;ORAL	208232-001	Jun 26, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for MYCAPSSA

See the table below for patents covering MYCAPSSA around the world.

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Country	Patent Number	Title	Estimated Expiration
Spain	2629131		⤷ Sign Up
Morocco	41462	MÉTHODE DE TRAITEMENT DE MALADIES	⤷ Sign Up
Japan	2014074069	PHARMACEUTICAL COMPOSITION, AND RELATED DELIVERY METHOD	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration