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 | 8,227,484 | ⤷ Start Trial |
| 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 | RE38115 | ⤷ 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 |
| >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 |
|---|---|---|
| Japan | 2017088620 | ⤷ Start Trial |
| Germany | 60321929 | ⤷ Start Trial |
| Japan | 2011225601 | ⤷ Start Trial |
| Poland | 374026 | ⤷ Start Trial |
| Australia | 2010212348 | ⤷ 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 | 1390056-8 | Sweden | ⤷ Start Trial | PRODUCT NAME: KOMBINATION AV (A) DEXTROMETORFAN ELLER ETT FARMACEUTISKT GODTAGBART SALT, PREKURSOR ELLER DERIVAT DAERAV, TEX. DEXTROMETORFAN-HYDROBROMID OCH I SYNNERHET DEXTROMETORFAN- HYDROBROMID MONOHYDRAT OCH (B) KINIDIN ELLER ETT FARMACEUTISKT GODTAGBART SALT, PREKURSOR ELLER DERIVAT DAERAV, TEX. KINIDINSULFAT OCH I SYNNERHET KINIDINSULFAT DIHYDRAT; REG. NO/DATE: EU/1/13/833 20130626 |
| 1539166 | CA 2013 00059 | Denmark | ⤷ Start Trial | PRODUCT NAME: KOMBINATION AF (A) DEXTROMETHORPHAN OG (B) QUNIDIN, HERUNDER DEXTROMETHORPHANHYDROBROMIDMONOHYDRAT OG QUINIDINSULFATDIHYDRAT; REG. NO/DATE: EU/1/13/833 20130624 |
| 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 | 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; |
| 1539166 | 92323 | Luxembourg | ⤷ Start Trial | PRODUCT NAME: LA COMBINAISON DE (A) DEXTROMETHORPHAN OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, PRECURSEURS OU DERIVES , PAR EX. HYDROBROMURE DE DEXTROMETHORPHAN ET EN PARTICULIER HYDROBROMURE DE DEXTROMETHORPHAN MONOHYDRATE; ET(B) QUINIDINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES , PRECURSEURS OU DERIVES, PAR EX. SULFATE DE QUINIDINE ET EN PARTICULIER SULFATE DE QUINIDINE DEHYDRATE; FIRST REGISTRATION: 20130624 |
| >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.
