SAMSCA Drug Patent Profile
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Which patents cover Samsca, and what generic alternatives are available?
Samsca is a drug marketed by Otsuka and is included in one NDA. There are two patents protecting this drug and three Paragraph IV challenges.
This drug has eighty-six patent family members in twenty-four countries.
The generic ingredient in SAMSCA is tolvaptan. There are eight drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the tolvaptan profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Samsca
A generic version of SAMSCA was approved as tolvaptan by ALKEM LABS LTD on May 19th, 2020.
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Summary for SAMSCA
| International Patents: | 86 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 101 |
| Clinical Trials: | 37 |
| Patent Applications: | 1,174 |
| Drug Prices: | Drug price information for SAMSCA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for SAMSCA |
| What excipients (inactive ingredients) are in SAMSCA? | SAMSCA excipients list |
| DailyMed Link: | SAMSCA at DailyMed |
Recent Clinical Trials for SAMSCA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Otsuka Pharmaceutical Vietnam | N/A |
| Gia Dinh People Hospital | N/A |
| Chinese Pulmonary Vascular Disease Research Group | N/A |
Pharmacology for SAMSCA
| Drug Class | Vasopressin V2 Receptor Antagonist |
| Mechanism of Action | Vasopressin V2 Receptor Antagonists |
US Patents and Regulatory Information for SAMSCA
SAMSCA is protected by two US patents.
Patents protecting SAMSCA
Pharmaceutical solid preparation comprising benzazepines and production method thereof
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Process for preparing benzazepine compounds or salts thereof
Patent Number: ⤷ Sign Up
Patent 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Otsuka | SAMSCA | tolvaptan | TABLET;ORAL | 022275-001 | May 19, 2009 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Otsuka | SAMSCA | tolvaptan | TABLET;ORAL | 022275-002 | May 19, 2009 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Otsuka | SAMSCA | tolvaptan | TABLET;ORAL | 022275-001 | May 19, 2009 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Otsuka | SAMSCA | tolvaptan | TABLET;ORAL | 022275-002 | May 19, 2009 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Otsuka | SAMSCA | tolvaptan | TABLET;ORAL | 022275-003 | May 19, 2009 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Otsuka | SAMSCA | tolvaptan | TABLET;ORAL | 022275-003 | May 19, 2009 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for SAMSCA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Otsuka | SAMSCA | tolvaptan | TABLET;ORAL | 022275-001 | May 19, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Otsuka | SAMSCA | tolvaptan | TABLET;ORAL | 022275-002 | May 19, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Otsuka | SAMSCA | tolvaptan | TABLET;ORAL | 022275-003 | May 19, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Otsuka | SAMSCA | tolvaptan | TABLET;ORAL | 022275-003 | May 19, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Otsuka | SAMSCA | tolvaptan | TABLET;ORAL | 022275-002 | May 19, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Otsuka | SAMSCA | tolvaptan | TABLET;ORAL | 022275-001 | May 19, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for SAMSCA
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Otsuka Pharmaceutical Netherlands B.V. | Jinarc | tolvaptan | EMEA/H/C/002788 Jinarc is indicated to slow the progression of cyst development and renal insufficiency of autosomal dominant polycystic kidney disease (ADPKD) in adults with CKD stage 1 to 3 at initiation of treatment with evidence of rapidly progressing disease. |
Authorised | no | no | no | 2015-05-27 | |
| Otsuka Pharmaceutical Netherlands B.V. | Samsca | tolvaptan | EMEA/H/C/000980 Treatment of adult patients with hyponatraemia secondary to syndrome of inappropriate antidiuretic-hormone secretion (SIADH)., |
Authorised | no | no | no | 2009-08-02 | |
| Accord Healthcare S.L.U. | Tolvaptan Accord | tolvaptan | EMEA/H/C/005961 Tolvaptan is indicated in adults for the treatment of hyponatremia secondary to the syndrome of inappropriate antidiuretic hormone secretion (SIADH). |
Authorised | yes | no | no | ||
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for SAMSCA
When does loss-of-exclusivity occur for SAMSCA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Austria
Patent: 96895
Estimated Expiration: ⤷ Sign Up
Patent: 44744
Estimated Expiration: ⤷ Sign Up
China
Patent: 1273017
Patent: Method of manufacturing benzoazepin compound or its salt
Estimated Expiration: ⤷ Sign Up
Patent: 1967107
Patent: Method of manufacturing benzoazepin compound or its salt
Estimated Expiration: ⤷ Sign Up
Patent: 2219741
Patent: Process for preparing benzazepine compounds or salts thereof
Estimated Expiration: ⤷ Sign Up
Patent: 2746229
Patent: Process for preparing benzazepine compounds or salts thereof
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 11788
Estimated Expiration: ⤷ Sign Up
Patent: 12496
Estimated Expiration: ⤷ Sign Up
Patent: 16082
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 19874
Estimated Expiration: ⤷ Sign Up
Patent: 51319
Estimated Expiration: ⤷ Sign Up
Patent: 61215
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 19874
Patent: PROCEDE DE PREPARATION DE COMPOSES DE BENZAZEPINE OU DE SELS DESDITS COMPOSES (PROCESS FOR PREPARING BENZAZEPINE COMPOUNDS OR SALTS THEREOF)
Estimated Expiration: ⤷ Sign Up
Patent: 51319
Patent: Procédés pour préparer des dérivés d' acide benzoïque (Process for preparing derivatives of benzoic acid)
Estimated Expiration: ⤷ Sign Up
Patent: 61215
Patent: Procédé de préparation de composés de benzazépine ou de leurs sels (Process for preparing benzazepine compounds or salts thereof)
Estimated Expiration: ⤷ Sign Up
Germany
Patent: 2006019882
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 24318
Patent: PROCESS FOR PREPARING BENZAZEPINE COMPOUNDS OR SALTS THEREOF
Estimated Expiration: ⤷ Sign Up
Patent: 44932
Patent: PROCESS FOR PREPARING DERIVATIVES OF BENZOIC ACID
Estimated Expiration: ⤷ Sign Up
Patent: 45835
Patent: 製備苯並氮雜卓化合物或其鹽的方法 (PROCESS FOR PREPARING BENZAZEPINE COMPOUNDS OR SALTS THEREOF)
Estimated Expiration: ⤷ Sign Up
Patent: 48999
Patent: THE PROCESS FOR PREPARING BENZAZEPINE COMPOUNDS OR SALTS THEREOF
Estimated Expiration: ⤷ Sign Up
Patent: 72329
Patent: 製備苯並氮雜䓬化合物或其鹽的方法 (PROCESS FOR PREPARING BENZAZEPINE COMPOUNDS OR SALTS THEREOF)
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 9481
Patent: תהליך עבור הפקת תרכובות 2,3,4,5-טטרההידרו-h1-1-בנזאזפין או מלחים מזה ותרכובת נקייה מאוד המופקת על ידי תהליך האמור (Process for producing 2,3,4,5-tetrahydro-1h-1- benzazepine compounds or salts thereof and highly pure compounds produced by said process)
Estimated Expiration: ⤷ Sign Up
Patent: 7444
Patent: תהליך עבור תרכובות בנזאפין או מלחים מזה (Process for preparing benzazepine compounds or salts thereof)
Estimated Expiration: ⤷ Sign Up
Patent: 7445
Patent: תהליך עבור ייצור תרכובת חומצה בנזאוית (Process for producing a benzoic acid compound)
Estimated Expiration: ⤷ Sign Up
Patent: 7446
Patent: תכשיר רוקחי המכיל מרכיב פעיל מטוהר מאוד של 7- כלורו - 5 - הידרוקסי- 1- [2-מתיל-4-(2-מתילבנזואיל-אמינו)בנזואיל]-2, 3, 4, 5 - טטראהידרו- h 1 - 1 - בנזאזפין בעל טוהר של יותר מ - 99.5% או מלח שלו, או תכשיר רוקחות של מלח שלו (Pharmaceutical composition comprising as an active ingredient a highly pure 7-chloro-5-hydroxy-1-[2-methyl-4-(2-methyl¬benzoyl¬amino)benzoyl]-2,3,4,5-tetrahydro-1h-1-benzazepine having a purity of more than 99.5 %, or a salt thereof, or a pharmaceutically acceptable salt thereof)
Estimated Expiration: ⤷ Sign Up
Patent: 2396
Patent: תהליך הכנה תרכובת ל 4-(בנזואילאמינו) חומצה בנזואיק או מלחים שלהם (Process for preparing 4-(benzoylamino)benzoic acid compounds or salts thereof)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 46587
Estimated Expiration: ⤷ Sign Up
Patent: 83172
Estimated Expiration: ⤷ Sign Up
Patent: 84164
Estimated Expiration: ⤷ Sign Up
Patent: 93083
Estimated Expiration: ⤷ Sign Up
Patent: 07091738
Patent: METHOD OF MANUFACTURING BENZOAZEPIN COMPOUND OR ITS SALT
Estimated Expiration: ⤷ Sign Up
Patent: 12176979
Patent: METHOD FOR PREPARING BENZAZEPINE COMPOUND OR SALT THEREOF
Estimated Expiration: ⤷ Sign Up
Patent: 12197295
Patent: PROCESS FOR PREPARING BENZOAZEPINE COMPOUND OR SALT THEREOF
Estimated Expiration: ⤷ Sign Up
Patent: 12197296
Patent: PROCESS FOR PRODUCING BENZOAZEPINE COMPOUND OR SALT THEREOF
Estimated Expiration: ⤷ Sign Up
Patent: 14139203
Patent: METHOD OF PRODUCING BENZOAZEPINE COMPOUND OR SALT THEREOF
Estimated Expiration: ⤷ Sign Up
Patent: 14205699
Patent: ベンゾアゼピン化合物又はその塩の製造方法 (PRODUCTION METHOD OF BENZOAZEPINE COMPOUND OR SALT THEREOF)
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 19874
Estimated Expiration: ⤷ Sign Up
Patent: 51319
Estimated Expiration: ⤷ Sign Up
Patent: 61215
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 19874
Estimated Expiration: ⤷ Sign Up
Patent: 51319
Estimated Expiration: ⤷ Sign Up
Patent: 61215
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 19874
Estimated Expiration: ⤷ Sign Up
Patent: 51319
Estimated Expiration: ⤷ Sign Up
Patent: 61215
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1019363
Estimated Expiration: ⤷ Sign Up
Patent: 1077329
Estimated Expiration: ⤷ Sign Up
Patent: 1119732
Estimated Expiration: ⤷ Sign Up
Patent: 080039459
Patent: PROCESS FOR PREPARING BENZAZEPINE COMPOUNDS OR SALTS THEREOF
Estimated Expiration: ⤷ Sign Up
Patent: 100132087
Patent: PROCESS FOR PREPARING BENZAZEPINE COMPOUNDS OR SALTS THEREOF
Estimated Expiration: ⤷ Sign Up
Patent: 100133028
Patent: PROCESS FOR PREPARING BENZAZEPINE COMPOUNDS OR SALTS THEREOF
Estimated Expiration: ⤷ Sign Up
Patent: 110029184
Patent: PROCESS FOR PREPARING BENZAZEPINE COMPOUNDS OR SALTS THEREOF
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 58217
Estimated Expiration: ⤷ Sign Up
Patent: 79153
Estimated Expiration: ⤷ Sign Up
Patent: 27794
Estimated Expiration: ⤷ Sign Up
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 SAMSCA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Japan | 5583172 | ⤷ Sign Up | |
| Cyprus | 1111939 | ⤷ Sign Up | |
| South Korea | 101077329 | ⤷ Sign Up | |
| Germany | 69026708 | ⤷ Sign Up | |
| Japan | 5046587 | ⤷ Sign Up | |
| China | 102219741 | Process for preparing benzazepine compounds or salts thereof | ⤷ Sign Up |
| South Korea | 0167349 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for SAMSCA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0450097 | SPC/GB09/037 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: TOLVAPTAN, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REGISTERED: UK EU/1/09/539/001 20090803; UK EU/1/09/539/002 20090803; UK EU/1/09/539/003 20090803; UK EU/1/09/539/004 20090803 |
| 0450097 | 300408 | Netherlands | ⤷ Sign Up | 300408, 20101018, EXPIRES: 20151017 |
| 0450097 | 09C0049 | France | ⤷ Sign Up | PRODUCT NAME: TOLVAPTAN, EVENTUELLEMENT SOUS FORME DE SEL; REGISTRATION NO/DATE: EU/1/09/539/001 20090803 |
| 0450097 | CA 2009 00031 | Denmark | ⤷ Sign Up | |
| 0450097 | C300408 | Netherlands | ⤷ Sign Up | PRODUCT NAME: TOLVAPTAN, DESGEWENST IN DE VORM VAN EEN ZOUT; REGISTRATION NO/DATE: EU/1/09/539/001-004 20090803 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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