AYTU Company Profile
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What is the competitive landscape for AYTU, and what generic alternatives to AYTU drugs are available?
AYTU has four approved drugs.
There are three US patents protecting AYTU drugs.
There are one hundred and five patent family members on AYTU drugs in sixteen countries and seven supplementary protection certificates in six countries.
Drugs and US Patents for AYTU
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Aytu | ACIPHEX SPRINKLE | rabeprazole sodium | CAPSULE, DELAYED RELEASE;ORAL | 204736-002 | Mar 26, 2013 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | |||||
Aytu Biopharma | METADATE CD | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021259-006 | Feb 19, 2006 | AB2 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ||||
Aytu Biopharma | METADATE CD | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021259-001 | Apr 3, 2001 | AB2 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ||||
Aytu | KARBINAL ER | carbinoxamine maleate | SUSPENSION, EXTENDED RELEASE;ORAL | 022556-001 | Mar 28, 2013 | RX | Yes | Yes | 8,062,667 | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Aytu Biopharma | METADATE CD | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021259-003 | May 27, 2003 | AB2 | RX | Yes | No | ⤷ 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 |
Expired US Patents for AYTU
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Aytu Biopharma | METADATE CD | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021259-001 | Apr 3, 2001 | 6,344,215 | ⤷ Sign Up |
Aytu Biopharma | METADATE CD | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021259-002 | Jun 19, 2003 | 6,344,215 | ⤷ Sign Up |
Aytu | ACIPHEX SPRINKLE | rabeprazole sodium | CAPSULE, DELAYED RELEASE;ORAL | 204736-001 | Mar 26, 2013 | 5,045,552*PED | ⤷ Sign Up |
Aytu Biopharma | METADATE CD | methylphenidate hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021259-004 | Feb 19, 2006 | 6,344,215 | ⤷ Sign Up |
Aytu | ZOLPIMIST | zolpidem tartrate | SPRAY, METERED;ORAL | 022196-001 | Dec 19, 2008 | 7,632,517 | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for AYTU drugs
Drugname | Dosage | Strength | Tradename | Submissiondate |
---|---|---|---|---|
➤ Subscribe | Extended-release Capsules | 40 mg | ➤ Subscribe | 2007-03-15 |
➤ Subscribe | Extended-release Capsules | 10 mg, 20 mg and 30 mg | ➤ Subscribe | 2005-05-13 |
Premature patent expirations for AYTU
Expiration due to failure to pay maintenance fee
Patent Number | Expiration Date |
---|---|
⤷ Sign Up | ⤷ Sign Up |
International Patents for AYTU Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
World Intellectual Property Organization (WIPO) | 2004043428 | ⤷ Sign Up |
Canada | 2581996 | ⤷ Sign Up |
Australia | 2007227569 | ⤷ Sign Up |
Australia | 2003270014 | ⤷ Sign Up |
World Intellectual Property Organization (WIPO) | 2005032519 | ⤷ Sign Up |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for AYTU Drugs
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0268956 | 1999C0030 | Belgium | ⤷ Sign Up | PRODUCT NAME: RABEPRAZOLE SODIUM; NAT. REGISTRATION NO/DATE: 5532 IE 1 F 3 19990201; FIRST REGISTRATION: GB 10555/0010 19980508 |
2236132 | 300714 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ZOLPIDEM EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN; NATIONAL REGISTRATION NO/DATE: RVG 108438 - 439 20160624; REGISTRATION NO/DATE: BE424286 20120718 BE424295 20120718 |
2236132 | 92636 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: ZOLPIDEM ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES |
2236132 | 122015000006 | Germany | ⤷ Sign Up | PRODUCT NAME: ZOLPIDEM UND PHARMAZEUTISCH VERTRAEGLICHE SALZE DAVON; NAT. REGISTRATION NO/DATE: 83439.00.00 83440.00.00 20120725 FIRST REGISTRATION: BELGIEN BE424286 BE424295 20120718 |
0268956 | SPC/GB98/040 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: RABEPRAZOLE, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE SODIUM SALT; REGISTERED: UK 10555/0010 19980508; UK 10555/0008 19980508 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.