MYCAPSSA Drug Patent Profile

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

Mycapssa is a drug marketed by Amryt and is included in one NDA. There are ten patents protecting this drug.

This drug has sixty-two 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. Nine 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:	62
US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	22
Clinical Trials:	2
Patent Applications:	774
Formulation / Manufacturing:	see details
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

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Pharmacology for MYCAPSSA

Drug Class	Somatostatin Analog
Mechanism of Action	Somatostatin Receptor Agonists

Anatomical Therapeutic Chemical (ATC) Classes for MYCAPSSA

H01CB	Somatostatin and analogues
H01C	HYPOTHALAMIC HORMONES
H01	PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES
H	Systemic hormonal preparations, excluding sex hormones and insulins

US Patents and Regulatory Information for MYCAPSSA

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

Patents protecting MYCAPSSA

Method of treating diseases
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF ORAL OCTREOTIDE FOR LONG-TERM MAINTENANCE TREATMENT IN ACROMEGALY PATIENTS WHILE AVOIDING CONCOMITANT ADMINISTRATION OF LEVONORGESTREL

Pharmaceutical compositions and related methods of delivery
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Pharmaceutical compositions and related methods of delivery
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

FDA Regulatory Exclusivity protecting MYCAPSSA

NEW PRODUCT
Exclusivity Expiration: ⤷ Try a Trial

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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
Amryt	MYCAPSSA	octreotide acetate	CAPSULE, DELAYED RELEASE;ORAL	208232-001	Jun 26, 2020		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Amryt	MYCAPSSA	octreotide acetate	CAPSULE, DELAYED RELEASE;ORAL	208232-001	Jun 26, 2020		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Amryt	MYCAPSSA	octreotide acetate	CAPSULE, DELAYED RELEASE;ORAL	208232-001	Jun 26, 2020		RX	Yes	Yes	⤷ 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

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
South Korea	101683314		⤷ Try a Trial
United Kingdom	2482810	Enhanced delivery of exenatide using a medium chain fatty acid and salt thereof	⤷ Try a Trial
Russian Federation	2015112963	ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ И СООТВЕТСТВУЮЩИЕ СПОСОБЫ ДОСТАВКИ	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration