Otsuka America Pharm Company Profile
What is the competitive landscape for OTSUKA AMERICA PHARM
OTSUKA AMERICA PHARM has one approved drug.
There is one US patent protecting OTSUKA AMERICA PHARM drugs.
Summary for Otsuka America Pharm
| US Patents: | 1 |
| Tradenames: | 1 |
| Ingredients: | 1 |
| NDAs: | 1 |
Drugs and US Patents for Otsuka America Pharm
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Otsuka America Pharm | NUEDEXTA | dextromethorphan hydrobromide; quinidine sulfate | CAPSULE;ORAL | 021879-001 | Oct 29, 2010 | AB | RX | Yes | Yes | 7,659,282 | ⤷ Start Trial | ⤷ Start Trial | |||
| >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 Otsuka America Pharm
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Otsuka America Pharm | NUEDEXTA | dextromethorphan hydrobromide; quinidine sulfate | CAPSULE;ORAL | 021879-001 | Oct 29, 2010 | 5,166,207 | ⤷ Start Trial |
| Otsuka America Pharm | NUEDEXTA | dextromethorphan hydrobromide; quinidine sulfate | CAPSULE;ORAL | 021879-001 | Oct 29, 2010 | 8,227,484 | ⤷ Start Trial |
| Otsuka America Pharm | NUEDEXTA | dextromethorphan hydrobromide; quinidine sulfate | CAPSULE;ORAL | 021879-001 | Oct 29, 2010 | 7,659,282 | ⤷ Start Trial |
| Otsuka America Pharm | NUEDEXTA | dextromethorphan hydrobromide; quinidine sulfate | CAPSULE;ORAL | 021879-001 | Oct 29, 2010 | 5,206,248 | ⤷ Start Trial |
| Otsuka America Pharm | NUEDEXTA | dextromethorphan hydrobromide; quinidine sulfate | CAPSULE;ORAL | 021879-001 | Oct 29, 2010 | RE38115 | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for OTSUKA AMERICA PHARM drugs
| Drugname | Dosage | Strength | Tradename | Submissiondate |
|---|---|---|---|---|
| ➤ Subscribe | Capsules | 20 mg/10 mg | ➤ Subscribe | 2011-03-07 |
International Patents for Otsuka America Pharm Drugs
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Portugal | 1980252 | ⤷ Start Trial |
| Spain | 2309351 | ⤷ Start Trial |
| Luxembourg | 92323 | ⤷ Start Trial |
| Japan | 2021098743 | ⤷ Start Trial |
| Japan | 5082032 | ⤷ Start Trial |
| Japan | 2017036337 | ⤷ Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for Otsuka America Pharm Drugs
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1539166 | 451 | Finland | ⤷ Start Trial | |
| 1539166 | 122013000090 | Germany | ⤷ Start Trial | PRODUCT NAME: KOMBINATION AUS: (A) DEXTROMETHORPHAN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ, Z.B. DEXTROMETHORPHAN-HYDROBROMID UND INSBESONDERE DEXTROMETHORPHAN-HYDROBROMID-MONOHYDRAT; UND (B) CHINIDIN ODER EINEM PHARMAZEUTISCH VERTRAEGLICHEN SALZ DAVON, Z.B.CHINIDIN-SULFAT UND INSBESONDERE CHINIDIN-SULFAT-DIHYDRAT; REGISTRATION NO/DATE: EU/1/13/833 20130624 |
| 1539166 | 60/2013 | Austria | ⤷ Start Trial | PRODUCT NAME: KOMBINATION VON A) DEXTROMETHORPHAN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, BEISPIELSWEISE DEXTROMETHORPHANHYDROBROMID, UND INSBESONDERE DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT UND B) CHINIDIN ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, BEISPIELSWEISE CHINIDINSULFAT, UND INSBESONDERE CHINIDINSULFATDIHYDRAT.; REGISTRATION NO/DATE: EU/1/13/833 20130626 |
| 1539166 | 2013/055 | Ireland | ⤷ Start Trial | PRODUCT NAME: THE COMBINATION OF: (A) DEXTROMETHORPHAN OR A PHARMACEUTICALLY ACCEPTABLE SALT, PRECURSOR OR DERIVATIVE THEREOF, E.G. DEXTROMETHORPHAN HYDROBROMIDE AND IN PARTICULAR DEXTROMETHORPHAN HYDROBROMIDE MONOHYDRATE; AND (B) QUINIDINE OR A PHARMACEUTICALLY ACCEPTABLE SALT, PRECURSOR OR DERIVATIVE THEREOF, E.G. QUINIDINE SULPHATE AND IN PARTICULAR QUINIDINE SULPHATE DIHYDRATE, PROTECTED BY THE BASIC PATENT; REGISTRATION NO/DATE: EU/1/13/833 20130624 |
| 1539166 | C300626 | Netherlands | ⤷ Start Trial | PRODUCT NAME: COMBINATIE VAN: (A) DEXTROMETHORFAN, DESGEWENST; REGISTRATION NO/DATE: EU/1/13/833 20130624 |
| 1539166 | C 2013 034 | Romania | ⤷ Start Trial | PRODUCT NAME: COMBINATIE A DEXTROMETORFANULUI SAU A UNEI SARIACCEPTABILE FARMACEUTIC, DE EXEMPLU DEXNATIONAL AUTHORISATION NUMBER: EU/1/13/833/001, EU/1/13/833/002, EU/1/13/833/003; DATE OF NATIONAL AUTHORISATION: 20130624; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/833/001, EU/1/13/833/002, EU/1/13/833/003; DATE OF FIRST AUTHORISATION IN EEA: 20130624 TROMETORFAN BROMHIDRAT SI PARTICULAR DEXTROMETORFAN BROMHIDRATMONOHIDRAT SI CHINIDINA SAU O SARE ACCEPTABILA FARMACEUTIC, DE EXEMPLU SULFAT DE CHINIDINA SI IN PAR TICULAR SULFATDE CHINIDINA DIHIDRAT; |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.
Here is a list of applicants with similar names.
