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 |
Recent Clinical Trials for MYCAPSSA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Chiasma, Inc. | Phase 3 |
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
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
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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
Method of treating diseases
Patent Number: ⤷ Sign Up
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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
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
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
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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
Patent Number: ⤷ Sign Up
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Patent Number: ⤷ Sign Up
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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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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 |