nurtec odt Drug Patent Profile
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Which patents cover Nurtec Odt, and what generic alternatives are available?
Nurtec Odt is a drug marketed by Pfizer and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.
This drug has one hundred and six patent family members in thirty-six countries.
The generic ingredient in NURTEC ODT is rimegepant sulfate. One supplier is listed for this compound. Additional details are available on the rimegepant sulfate profile page.
DrugPatentWatch® Generic Entry Outlook for Nurtec Odt
Nurtec Odt was eligible for patent challenges on February 27, 2024.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be February 25, 2033. This may change due to patent challenges or generic licensing.
There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.
Indicators of Generic Entry
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Summary for nurtec odt
International Patents: | 106 |
US Patents: | 3 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 2 |
Clinical Trials: | 2 |
Drug Prices: | Drug price information for nurtec odt |
What excipients (inactive ingredients) are in nurtec odt? | nurtec odt excipients list |
DailyMed Link: | nurtec odt at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for nurtec odt
Generic Entry Date for nurtec odt*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET, ORALLY DISINTEGRATING;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 nurtec odt
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Antonios Likourezos | Phase 4 |
Weill Medical College of Cornell University | Phase 2 |
Biohaven Pharmaceuticals, Inc. | Phase 2 |
Pharmacology for nurtec odt
Drug Class | Calcitonin Gene-related Peptide Receptor Antagonist |
Mechanism of Action | Calcitonin Gene-related Peptide Receptor Antagonists |
Paragraph IV (Patent) Challenges for NURTEC ODT
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
NURTEC ODT | Orally Disintegrating Tablets | rimegepant sulfate | 75 mg | 212728 | 7 | 2024-02-27 |
US Patents and Regulatory Information for nurtec odt
nurtec odt is protected by five US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of nurtec odt is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ 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.
Patents protecting nurtec odt
Rimegepant for CGRP related disorders
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN ADULTS
Rimegepant for CGRP related disorders
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: PREVENTIVE TREATMENT OF EPISODIC MIGRAINE IN ADULTS
CGRP receptor antagonists
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA IN ADULTS
CGRP receptor antagonists
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: PREVENTIVE TREATMENT OF EPISODIC MIGRAINE IN ADULTS
N-(5S,6S,9R)-amino-6-(2,3-difluorophenyl)-6,7,8,9-tetrahydro-5H-ctclohepta- [b]Pyridin-9-yl-4-(2-oxo-2,3-dihydro-1H-imidazo[4,5-b]pyridin-1-carboxylat- e salt
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting nurtec odt
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
FOR THE PREVENTIVE TREATMENT OF EPISODIC MIGRAINE IN ADULTS
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pfizer | NURTEC ODT | rimegepant sulfate | TABLET, ORALLY DISINTEGRATING;ORAL | 212728-001 | Feb 27, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Pfizer | NURTEC ODT | rimegepant sulfate | TABLET, ORALLY DISINTEGRATING;ORAL | 212728-001 | Feb 27, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Pfizer | NURTEC ODT | rimegepant sulfate | TABLET, ORALLY DISINTEGRATING;ORAL | 212728-001 | Feb 27, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Pfizer | NURTEC ODT | rimegepant sulfate | TABLET, ORALLY DISINTEGRATING;ORAL | 212728-001 | Feb 27, 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 nurtec odt
When does loss-of-exclusivity occur for nurtec odt?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 13226361
Patent: N- (5S, 6S, 9R) - 5 -amino- 6 - (2, 3 - difluorophenyl) -6, 7, 8, 9 - tetrahydro - 5H - cyclohepta [b] pyridin-9 -yl- 4 - (2 - oxo-2, 3 - dihydro - 1H- imidazo [4, 5 -b] pyridin - 1 - yl) piperidine - 1 - carboxylate, hemisulfate salt
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2014021032
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 65585
Patent: N- (5S, 6S, 9R) -5 -AMINO- 6 - (2, 3 - DIFLUOROPHENYL) -6, 7, 8, 9 -TETRAHYDRO - 5H - CYCLOHEPTA [B] PYRIDINE-9 -YL- 4- (2 - OXO-2, 3 -DIHYDRO - 1H- IMIDAZO [4, 5 -B] PYRIDINE - 1 - YL) PIPERIDINE - 1 -CARBOXYLATE, SEL D'HEMISULFATE (N- (5S, 6S, 9R) - 5 -AMINO- 6 - (2, 3 - DIFLUOROPHENYL) -6, 7, 8, 9 - TETRAHYDRO - 5H - CYCLOHEPTA [B] PYRIDIN-9 -YL- 4 - (2 - OXO-2, 3 - DIHYDRO - 1H- IMIDAZO [4, 5 -B] PYRIDIN - 1 - YL) PIPERIDINE - 1 - CARBOXYLATE, HEMISULFATE SALT)
Estimated Expiration: ⤷ Sign Up
China
Patent: 4136437
Patent: N-(5S,6S,9R)-5-AMINO-6-(2,3-DIFLUOROPHENYL)-6,7,8,9-TETRAHYDRO-5H-CYCLOHEPTA[B]PYRIDIN-9-YL-4-(2-OXO-2,3-DIHYDRO-1H-IMIDAZO[4,5-B]PYRIDIN-1-YL)PIPERIDINE-1-CARBOXYLATE,HEMISULFATE SALT
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0171620
Estimated Expiration: ⤷ Sign Up
Patent: 0191655
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 19448
Estimated Expiration: ⤷ Sign Up
Patent: 22121
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 20016
Estimated Expiration: ⤷ Sign Up
Patent: 54681
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 5358
Patent: N-(5S,6S,9R)-5-АМИНО-6-(2,3-ДИФТОРФЕНИЛ)-6,7,8,9-ТЕТРАГИДРО-5H-ЦИКЛОГЕПТА[b]ПИРИДИН-9-ИЛ-4-(2-ОКСО-2,3-ДИГИДРО-1H-ИМИДАЗО[4,5-b]ПИРИДИН-1-ИЛ)ПИПЕРИДИН-1-КАРБОКСИЛАТНАЯ СОЛЬ (N-(5S,6S,9R)-5-AMINO-6-(2,3-DIFLUOROPHENYL)-6,7,8,9-TETRAHYDRO-5H-CYCLOHEPTA[b]PYRIDIN-9-YL-4-(2-OXO-2,3-DIHYDRO-1H-IMIDAZO[4,5-b]PYRIDIN-1-YL)PIPERIDINE-1-CARBOXYLATE SALT)
Estimated Expiration: ⤷ Sign Up
Patent: 1491585
Patent: N-(5S,6S,9R)-5-АМИНО-6-(2,3-ДИФТОРФЕНИЛ)-6,7,8,9-ТЕТРАГИДРО-5H-ЦИКЛОГЕПТА[B]ПИРИДИН-9-ИЛ-4-(2-ОКСО-2,3-ДИГИДРО-1H-ИМИДАЗО[4,5-B]ПИРИДИН-1-ИЛ)ПИПЕРИДИН-1-КАРБОКСИЛАТНАЯ СОЛЬ
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 20016
Patent: N- (5S, 6S, 9R) -5 -AMINO- 6 - (2, 3 - DIFLUOROPHÉNYL) -6, 7, 8, 9 -TÉTRAHYDRO - 5H - CYCLOHEPTA [B]PYRIDINE-9 -YL- 4- (2 - OXO-2, 3 -DIHYDRO - 1H- IMIDAZO [4, 5 -B]PYRIDINE - 1 - YL) PIPÉRIDINE - 1 -CARBOXYLATE, SEL D'HÉMISULFATE (N- (5S, 6S, 9R) - 5 -AMINO- 6 - (2, 3 - DIFLUOROPHENYL) -6, 7, 8, 9 - TETRAHYDRO - 5H - CYCLOHEPTA [B]PYRIDIN-9 -YL- 4 - (2 - OXO-2, 3 - DIHYDRO - 1H- IMIDAZO [4, 5 -B]PYRIDIN - 1 - YL) PIPERIDINE - 1 - CARBOXYLATE, HEMISULFATE SALT)
Estimated Expiration: ⤷ Sign Up
Patent: 54681
Patent: SEL DE N-(5S, 6S, 9R)-5-AMINO-6-(2,3-DIFLUOROPHÉNYL) -6,7,8,9-TETRAHYDRO-5H-CYCLOHEPTA[B]PYRIDIN-9-YL-4- (2-OXO-2,3-DIHYDRO-1H-IMIDAZO[4,5-B]PYRIDIN-1-YL)PIPERIDINE-1-CARBOXYLATE (N-(5S,6S,9R)-5-AMINO-6-(2,3-DIFLUOROPHENYL)-6,7,8,9-TETRAHYDRO-5H-CYCLOHEPTA[B]PYRIDIN-9-YL-4-(2-OXO-2,3-DIHYDRO-1H-IMIDAZO[4,5-B]PYRIDIN-1-YL)PIPERIDINE-1-CARBOXYLATE SALT)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 48111
Patent: N-(5S,6S,9R)-4-(2-氧代-2,3-二氫-1H-咪唑並[4,5-B]吡啶-1-基)呱啶-1-羧酸5-氨基-6-(2,3-二氟苯基)-6,7,8,9-四氫-5H-環庚三烯並[B]吡啶-9-基酯半硫酸鹽 (N-(5S,6S,9R)-5-AMINO-6-(2,3-DIFLUOROPHENYL)-6,7,8,9-TETRAHYDRO-5H-CYCLOHEPTA[B]PYRIDIN-9-YL-4-(2-OXO-2,3-DIHYDRO-1H-IMIDAZO[4,5-B]PYRIDIN-1-YL)PIPERIDINE-1-CARBOXYLATE SALT)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 34936
Estimated Expiration: ⤷ Sign Up
Patent: 47050
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 4272
Patent: מלח המיסולפט של n - (r9, s6, s5) - 5 אמינו - 6 - (2, 3 - דיפלואורופניל) - 6, 7, 8, 9, - טטראהידרו - h5 - ציקלוהפטא [b] פירידינ - 9 - איל - 4 - ( 2- אוקסו - 2, 3, דיהידרו - h1 - אימידאזו [5,4 -b] פירידינ- 1 - איל) פיפרידינ - 1 - קרבוקסילאט (N-(5s,6s,9r)-5-amino-6-(2,3-difluorophenyl)-6,7,8,9-tetrahydro-5h-cyclohepta[b]pyridin-9-yl-4-(2-oxo-2,3-dihydro-1h-imidazo[4,5-b]pyridin-1-yl)piperidine-1-carboxylate, hemisulfate salt)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 08154
Estimated Expiration: ⤷ Sign Up
Patent: 76253
Estimated Expiration: ⤷ Sign Up
Patent: 15511581
Patent: N−(5S,6S,9R)−5−アミノ−6−(2,3−ジフルオロフェニル)−6,7,8,9−テトラヒドロ−5H−シクロヘプタ[b]ピリジン−9−イル−4−(2−オキソ−2,3−ジヒドロ−1H−イミダゾ[4,5−b]ピリジン−1−イル)ピペリジン−1−カルボキシレート塩
Estimated Expiration: ⤷ Sign Up
Patent: 17226693
Patent: N−(5S,6S,9R)−5−アミノ−6−(2,3−ジフルオロフェニル)−6,7,8,9−テトラヒドロ−5H−シクロヘプタ[b]ピリジン−9−イル−4−(2−オキソ−2,3−ジヒドロ−1H−イミダゾ[4,5−b]ピリジン−1−イル)ピペリジン−1−カルボキシレート塩 (N-(5S,6S,9R)-5-AMINO-6-(2,3-DIFLUOROPHENYL)-6,7,8,9-TETRAHYDRO-5H-CYCLOHEPTA[B]PYRIDIN-9-YL-4-(2-OXO-2,3-DIHYDRO-1H-IMIDAZO[4,5-B]PYRIDIN-1-YL)PIPERIDINE-1-CARBOXYLATE SALT)
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 20016
Estimated Expiration: ⤷ Sign Up
Patent: 54681
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 2171
Patent: SAL DE HEMISULFATO DE N-(5S,6S,9R)-5-AMINO-6-(2,3-DIFLUOROFENIL)-6 ,7,8,9-TETRAHIDRO-5H-CICLOHEPTA[B]PIRIDIN-9-IL-4-(2-OXO-2,3-DIHID RO-1H-IMIDAZO[4,5-B]PIRIDIN-1-IL)PIPERIDINA-1-CARBOXILATO. (N- (5S, 6S, 9R) - 5 -AMINO- 6 - (2, 3 - DIFLUOROPHENYL) -6, 7, 8, 9 - TETRAHYDRO - 5H - CYCLOHEPTA [B] PYRIDIN-9 -YL- 4 - (2 - OXO-2, 3 - DIHYDRO - 1H- IMIDAZO [4, 5 -B] PYRIDIN - 1 - YL) PIPERIDINE - 1 - CARBOXYLATE, HEMISULFATE SALT.)
Estimated Expiration: ⤷ Sign Up
Patent: 14009544
Patent: SAL DE HEMISULFATO DE N-(5S,6S,9R)-5-AMINO-6-(2,3-DIFLUOROFENIL)-6 ,7,8,9-TETRAHIDRO-5H-CICLOHEPTA[B]PIRIDIN-9-IL-4-(2-OXO-2,3-DIHID RO-1H-IMIDAZO[4,5-B]PIRIDIN-1-IL)PIPERIDINA-1-CARBOXILATO. (N- (5S, 6S, 9R) - 5 -AMINO- 6 - (2, 3 - DIFLUOROPHENYL) -6, 7, 8, 9 - TETRAHYDRO - 5H - CYCLOHEPTA [B] PYRIDIN-9 -YL- 4 - (2 - OXO-2, 3 - DIHYDRO - 1H- IMIDAZO [4, 5 -B] PYRIDIN - 1 - YL) PIPERIDINE - 1 - CARBOXYLATE, HEMISULFATE SALT.)
Estimated Expiration: ⤷ Sign Up
Norway
Patent: 35439
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 20016
Estimated Expiration: ⤷ Sign Up
Patent: 54681
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 20016
Estimated Expiration: ⤷ Sign Up
Patent: 54681
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 556
Patent: N- (5S, 6S, 9R) - 5 -AMINO- 6 - (2, 3 - DIFLUOROFENIL) -6, 7, 8, 9 - TETRAHIDRO - 5H - CIKLOHEPTA [B]PIRIDIN-9 -IL- 4 - (2 - OKSO-2, 3 - DIHIDRO - 1H- IMIDAZO [4, 5 -B]PIRIDIN - 1 - IL) PIPERIDIN - 1 - KARBOKSILAT, HEMISULFATNA SO (N- (5S, 6S, 9R) - 5 -AMINO- 6 - (2, 3 - DIFLUOROPHENYL) -6, 7, 8, 9 - TETRAHYDRO - 5H - CYCLOHEPTA [B]PYRIDIN-9 -YL- 4 - (2 - OXO-2, 3 - DIHYDRO - 1H- IMIDAZO [4, 5 -B]PYRIDIN - 1 - YL) PIPERIDINE - 1 - CARBOXYLATE, HEMISULFATE SALT)
Estimated Expiration: ⤷ Sign Up
Patent: 295
Patent: N-(5S,6S,9R)-5-AMINO-6-(2,3-DIFLUOROFENIL)-6,7,8,9-TETRAHIDRO-5H-CIKLOHEPTA[B]PIRIDIN-9-IL-4-(2-OKSO-2,3-DIHIDRO-1H-IMIDAZO[4,5-B]PIRIDIN-1-IL)PIPERIDIN-1-KARBOKSILAT SO (N-(5S,6S,9R)-5-AMINO-6-(2,3-DIFLUOROPHENYL)-6,7,8,9-TETRAHYDRO-5H-CYCLOHEPTA[B]PYRIDIN-9-YL-4-(2-OXO-2,3-DIHYDRO-1H-IMIDAZO[4,5-B]PYRIDIN-1-YL)PIPERIDINE-1-CARBOXYLATE SALT)
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 201404834X
Patent: N- (5S, 6S, 9R) - 5 -AMINO- 6 - (2, 3 - DIFLUOROPHENYL) -6, 7, 8, 9 - TETRAHYDRO - 5H - CYCLOHEPTA [B] PYRIDIN-9 -YL- 4 - (2 - OXO-2, 3 - DIHYDRO - 1H- IMIDAZO [4, 5 -B] PYRIDIN - 1 - YL) PIPERIDINE - 1 - CARBOXYLATE, HEMISULFATE SALT
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 20016
Estimated Expiration: ⤷ Sign Up
Patent: 54681
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 2076118
Estimated Expiration: ⤷ Sign Up
Patent: 2220969
Estimated Expiration: ⤷ Sign Up
Patent: 140130140
Patent: N-(5S,6S,9R)-5-AMINO-6-(2,3-DIFLUOROPHENYL)-6,7,8,9-TETRAHYDRO-5H-CYCLOHEPTA[B]PYRIDIN-9-YL-4-(2-OXO-2,3-DIHYDRO-1H-IMIDAZO[4,5-B]PYRIDIN-1-YL)PIPERIDINE-1-CARBOXYLATE, HEMISULFATE SALT
Estimated Expiration: ⤷ Sign Up
Patent: 200016993
Patent: N-(5S,6S,9R)-5-아미노-6--6,7,8,9-테트라히드로-5H-시클로헵타[b]피리딘-9-일-4-(2-옥소-2,3-디히드로-1H-이미다조[4,5-b]피리딘-1-일)피페리딘-1-카르복실레이트, 헤미술페이트 염 (N-5S6S9R-5--6-23--6789--5H-[b]-9--4-2--23--1H-[45-b]-1--1- N-5S6S9R-5-AMINO-6-23-DIFLUOROPHENYL-6789-TETRAHYDRO-5H-CYCLOHEPTA[B]PYRIDIN-9-YL-4-2-OXO-23-DIHYDRO-1H-IMIDAZO[45-B]PYRIDIN-1-YLPIPERIDINE-1-CARBOXYLATE HEMISULFATE SALT)
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 42737
Estimated Expiration: ⤷ Sign Up
Patent: 46031
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 nurtec odt around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Cyprus | 1122121 | ⤷ Sign Up | |
Brazil | 112014021032 | ⤷ Sign Up | |
Canada | 2777518 | ANTAGONISTES DE RECEPTEUR CGRP (CGRP RECEPTOR ANTAGONISTS) | ⤷ Sign Up |
Brazil | 112020019396 | rimegepant para distúrbios relacionados a cgrt | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for nurtec odt
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2488512 | LUC00272 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: RIMEGEPANT OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/22/1645 20220426 |
2488512 | PA2022516 | Lithuania | ⤷ Sign Up | PRODUCT NAME: RIMEGEPANTAS ARBA JO FARMACINIU POZIURIU PRIIMTINOS DRUSKOS; REGISTRATION NO/DATE: EU/1/22/1645 20220425 |
2488512 | CA 2022 00036 | Denmark | ⤷ Sign Up | PRODUCT NAME: RIMEGEPANT ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/22/1645 20220426 |
2488512 | 122022000048 | Germany | ⤷ Sign Up | PRODUCT NAME: RIMEGEPANT ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/22/1645 20220425 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |