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Last Updated: January 27, 2023

SEYSARA Drug Patent Profile


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When do Seysara patents expire, and when can generic versions of Seysara launch?

Seysara is a drug marketed by Almirall and is included in one NDA. There are four patents protecting this drug.

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

The generic ingredient in SEYSARA is sarecycline hydrochloride. One supplier is listed for this compound. Additional details are available on the sarecycline hydrochloride profile page.

DrugPatentWatch® Generic Entry Outlook for Seysara

Seysara was eligible for patent challenges on October 1, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 9, 2033. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for SEYSARA
International Patents:67
US Patents:4
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 50
Clinical Trials: 1
Patent Applications: 99
Drug Prices: Drug price information for SEYSARA
What excipients (inactive ingredients) are in SEYSARA?SEYSARA excipients list
DailyMed Link:SEYSARA at DailyMed
Drug patent expirations by year for SEYSARA
Drug Prices for SEYSARA

See drug prices for SEYSARA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for SEYSARA
Generic Entry Date for SEYSARA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for SEYSARA

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

SponsorPhase
Derm Research, PLLCPhase 4

See all SEYSARA clinical trials

Pharmacology for SEYSARA

US Patents and Regulatory Information for SEYSARA

SEYSARA is protected by five US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of SEYSARA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting SEYSARA

Substituted tetracycline compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD FOR TREATING A BACTERIAL INFECTION IN INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS PATIENTS 9 YEARS OF AGE AND OLDER COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF SARECYCLINE HYDROCHLORIDE

Substituted tetracycline compounds for treatment of inflammatory skin disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD FOR TREATING A PATIENT 9 YEARS OF AGE AND OLDER SUFFERING FROM AN INFLAMMATORY SKIN DISORDER OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF SARECYCLINE HYDROCHLORIDE

Crystalline salts of (4S,4AS,5AR,12AS)-4-dimethylamino-3,10,12,12A-tetrahydroxy-7-[methoxy(met- hyl)amino)-methyl] acid amide and methods of using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD FOR TREATING ACNE IN INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS PATIENTS 9 YEARS OF AGE AND OLDER COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF SARECYCLINE HYDROCHLORIDE CRYSTALLINE SALT

Crystalline salts of (4S,4AS,5AR,12AS)-4-dimethylamino-3,10,12,12A-tetrahydroxy-7-[methoxy(met- hyl)amino)-methyl] acid amide and methods of using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD FOR TREATING A BACTERIAL INFECTION IN INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS PATIENTS 9 YEARS OF AGE AND OLDER COMPRISING ADMINISTERING AN EFFECTIVE AMOUNT OF SARECYCLINE HYDROCHLORIDE CRYSTALLINE SALT

Substituted tetracycline compounds for treatment of inflammatory skin disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: A METHOD FOR TREATING ACNE IN INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS PATIENTS 9 YEARS OF AGE AND OLDER COMPRISING ADMINISTERING SARECYCLINE HYDROCHLORIDE IN 60 MG, 100 MG OR 150 MG EQUIVALENT DOSES

FDA Regulatory Exclusivity protecting SEYSARA

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Almirall SEYSARA sarecycline hydrochloride TABLET;ORAL 209521-001 Oct 1, 2018 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Almirall SEYSARA sarecycline hydrochloride TABLET;ORAL 209521-003 Oct 1, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Almirall SEYSARA sarecycline hydrochloride TABLET;ORAL 209521-002 Oct 1, 2018 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Almirall SEYSARA sarecycline hydrochloride TABLET;ORAL 209521-001 Oct 1, 2018 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Almirall SEYSARA sarecycline hydrochloride TABLET;ORAL 209521-002 Oct 1, 2018 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Almirall SEYSARA sarecycline hydrochloride TABLET;ORAL 209521-002 Oct 1, 2018 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Almirall SEYSARA sarecycline hydrochloride TABLET;ORAL 209521-003 Oct 1, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 SEYSARA

When does loss-of-exclusivity occur for SEYSARA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Canada

Patent: 35876
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0191295
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 07003
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 07003
Estimated Expiration: See Plans and Pricing

Patent: 74908
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 44536
Estimated Expiration: See Plans and Pricing

Japan

Patent: 74572
Estimated Expiration: See Plans and Pricing

Patent: 76082
Estimated Expiration: See Plans and Pricing

Patent: 14520077
Estimated Expiration: See Plans and Pricing

Patent: 17132775
Estimated Expiration: See Plans and Pricing

Patent: 19142867
Estimated Expiration: See Plans and Pricing

Patent: 21098695
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 07003
Estimated Expiration: See Plans and Pricing

Poland

Patent: 07003
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 07003
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 07003
Estimated Expiration: See Plans and Pricing

Spain

Patent: 39626
Estimated Expiration: See Plans and Pricing

Turkey

Patent: 1911086
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering SEYSARA around the world.

Country Patent Number Title Estimated Expiration
Israel 234755 נגזרות טטרציקלין לטיפול בדלקות חיידקיות, נגיפיות וטפיליות (Tetracycline derivatives for the treatment of bacterial, viral and parasitic infections) See Plans and Pricing
Lithuania 2120963 See Plans and Pricing
Canada 2673486 UTILISATION DE COMPOSES A BASE DE TETRACYCLINE SUBSTITUEE DANS LE TRAITEMENT D'AFFECTIONS CUTANEES INFLAMMATOIRES (SUBSTITUTED TETRACYCLINE COMPOUNDS FOR TREATMENT OF INFLAMMATORY SKIN DISORDERS) See Plans and Pricing
Japan 2015205939 細菌感染、ウイルス感染、および寄生虫感染の治療のためのテトラサイクリン誘導体 (TETRACYCLINE DERIVATIVE FOR TREATMENT OF BACTERIA INFECTION, VIRUS INFECTION AND PARASITE INFECTION) See Plans and Pricing
European Patent Office 3488853 COMPOSÉS DE TÉTRACYCLINE SUBSTITUÉS POUR LE TRAITEMENT DE TROUBLES INFLAMMATOIRES DE LA PEAU (SUBSTITUTED TETRACYCLINE COMPOUNDS FOR TREATMENT OF INFLAMMATORY SKIN DISORDERS) See Plans and Pricing
European Patent Office 2109602 DERIVÉS DE LA TETRACYCLINE POUR LE TRAITEMENT DE INFECTIONS BACTERIELLES, VIRALES ET PARASITIQUES (TETRACYCLINE DERIVATIVES FOR THE TREATMENT OF BACTERIAL, VIRAL AND PARASITIC INFECTIONS) See Plans and Pricing
Poland 2109602 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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Medtronic
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Express Scripts
Boehringer Ingelheim

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.