Otsuka America Pharm Company Profile
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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 | RE38115 | ⤷ 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 | 8,227,484 | ⤷ 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 |
|---|---|---|
| European Patent Office | 2322179 | ⤷ Start Trial |
| Spain | 2553654 | ⤷ Start Trial |
| Norway | 20050807 | ⤷ 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 | 2013C/064 | Belgium | ⤷ Start Trial | PRODUCT NAME: DEXTROMETHORPHANE OU UN SEL, PRCURSEUR DE DERIVE PHARMACEUTIQUEMENT ACCEPTABLE, PAR EXEMPLE LE BROMHYDRURE DE DEXTROMETORPHANE ET EN PARTICULIER LE BROMHYDRURE DE DEXTROMETROPHANE MONHYDRATE ET QUINIDINE OU UN SEL,....; AUTHORISATION NUMBER AND DATE: EU/1/13/833 20130626 |
| 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 | 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 |
| >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.
