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Last Updated: October 7, 2024

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 8th, 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
Drug Prices for MYCAPSSA

See drug prices for MYCAPSSA

Recent Clinical Trials for MYCAPSSA

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

SponsorPhase
Chiasma, Inc.Phase 3

See all MYCAPSSA clinical trials

Pharmacology for MYCAPSSA
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
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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

Method of treating diseases
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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

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

Method of treating diseases
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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

Method of treating diseases
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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


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Patent Expiration: ⤷  Sign Up
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


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: USE OF ORAL OCTREOTIDE FOR LONG-TERM MAINTENANCE TREATMENT IN ACROMEGALY PATIENTS WHILE AVOIDING CONCOMITANT ADMINISTRATION OF LEVONORGESTREL


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Pharmaceutical compositions and related methods of delivery
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
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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

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
Chiesi MYCAPSSA octreotide acetate CAPSULE, DELAYED RELEASE;ORAL 208232-001 Jun 26, 2020 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  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 Y ⤷  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.

Country Patent Number Title Estimated Expiration
South Africa 201705877 METHOD OF TREATING DISEASES ⤷  Sign Up
Brazil PI0918652 Composições farmacêuticas e métodos de libração relacionadas. ⤷  Sign Up
Canada 2963659 PREPARATIONS PHARMACEUTIQUES ET METHODES ASSOCIEES D'ADMINISTRATION (PHARMACEUTICAL COMPOSITIONS AND RELATED METHODS OF DELIVERY) ⤷  Sign Up
Slovenia 2343982 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2016126830 ⤷  Sign Up
Cyprus 1119148 ⤷  Sign Up
Mexico 2011002836 COMPOSICIONES FARMACEÚTICAS Y MÉTODOS DE ADMINISTRACIÓN RELACIONADOS. (PHARMACEUTICAL COMPOSITIONS AND RELATED METHODS OF DELIVERY.) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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