MYLAN SPECIALITY LP Company Profile
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What is the competitive landscape for MYLAN SPECIALITY LP, and when can generic versions of MYLAN SPECIALITY LP drugs launch?
MYLAN SPECIALITY LP has nineteen approved drugs.
There are twenty US patents protecting MYLAN SPECIALITY LP drugs.
There are one hundred and eighty-one patent family members on MYLAN SPECIALITY LP drugs in thirty-seven countries and sixty-nine supplementary protection certificates in seventeen countries.
Summary for MYLAN SPECIALITY LP
International Patents: | 181 |
US Patents: | 20 |
Tradenames: | 22 |
Ingredients: | 16 |
NDAs: | 19 |
Drugs and US Patents for MYLAN SPECIALITY LP
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan Speciality Lp | ROWASA | mesalamine | ENEMA;RECTAL | 019618-001 | Dec 24, 1987 | AB | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ||||
Mylan Speciality Lp | EPIPEN | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 019430-001 | Dec 22, 1987 | AB | RX | Yes | Yes | 9,586,010 | ⤷ Subscribe | Y | ⤷ Subscribe | ||
Mylan Speciality Lp | EPIPEN JR. | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 019430-002 | Dec 22, 1987 | AB | RX | Yes | Yes | 8,048,035 | ⤷ Subscribe | Y | ⤷ Subscribe | ||
Mylan Speciality Lp | ASTEPRO | azelastine hydrochloride | SPRAY, METERED;NASAL | 022203-001 | Oct 15, 2008 | DISCN | Yes | No | 8,071,073 | ⤷ Subscribe | Y | ⤷ Subscribe | |||
Mylan Speciality Lp | EPIPEN | epinephrine | INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS | 019430-001 | Dec 22, 1987 | AB | RX | Yes | Yes | 8,870,827 | ⤷ Subscribe | Y | ⤷ Subscribe | ||
Mylan Speciality Lp | ASTEPRO | azelastine hydrochloride | SPRAY, METERED;NASAL | 022203-001 | Oct 15, 2008 | DISCN | Yes | No | 8,518,919 | ⤷ Subscribe | ⤷ Subscribe | ||||
>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 MYLAN SPECIALITY LP
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Mylan Speciality Lp | MUSE | alprostadil | SUPPOSITORY;URETHRAL | 020700-003 | Nov 19, 1996 | 5,242,391 | ⤷ Subscribe |
Mylan Speciality Lp | MUSE | alprostadil | SUPPOSITORY;URETHRAL | 020700-004 | Nov 19, 1996 | 5,773,020 | ⤷ Subscribe |
Mylan Speciality Lp | TOBI PODHALER | tobramycin | POWDER;INHALATION | 201688-001 | Mar 22, 2013 | 11,484,671 | ⤷ Subscribe |
Mylan Speciality Lp | MUSE | alprostadil | SUPPOSITORY;URETHRAL | 020700-004 | Nov 19, 1996 | 5,474,535 | ⤷ Subscribe |
Mylan Speciality Lp | MUSE | alprostadil | SUPPOSITORY;URETHRAL | 020700-003 | Nov 19, 1996 | 5,773,020 | ⤷ Subscribe |
Mylan Speciality Lp | MUSE | alprostadil | SUPPOSITORY;URETHRAL | 020700-003 | Nov 19, 1996 | 4,801,587 | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for MYLAN SPECIALITY LP drugs
Drugname | Dosage | Strength | Tradename | Submissiondate |
---|---|---|---|---|
➤ Subscribe | Injection (Auto-injector) | 0.15 mg/0.3 mL and 0.3 mg/0.3 mL | ➤ Subscribe | 2008-11-21 |
➤ Subscribe | Nasal Spray | 205.5 mcg/spray | ➤ Subscribe | 2011-12-15 |
➤ Subscribe | Sublingual Tablets | 5 mg and 10 mg | ➤ Subscribe | 2010-04-29 |
➤ Subscribe | Injection (Auto-injector) | 0.15 mg/0.3 mL and 0.3 mg/0.3 mL | ➤ Subscribe | 2008-11-21 |
➤ Subscribe | Inhalation Solution | 300 mg/5 mL | ➤ Subscribe | 2009-06-29 |
➤ Subscribe | Nasal Spray | 137 mcg/50 mcg per spray | ➤ Subscribe | 2014-06-13 |
International Patents for MYLAN SPECIALITY LP Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
Portugal | 2311510 | ⤷ Subscribe |
Australia | 2003244799 | ⤷ Subscribe |
European Patent Office | 1615689 | ⤷ Subscribe |
Israel | 216931 | ⤷ Subscribe |
Israel | 183372 | ⤷ Subscribe |
South Korea | 20050119686 | ⤷ Subscribe |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for MYLAN SPECIALITY LP Drugs
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
0584952 | 99C0004 | Belgium | ⤷ Subscribe | PRODUCT NAME: ESTRADIOL, HEMIHYDRATE, NORETHISTERONE, ACETATE; NAT. REGISTRATION NO/DATE: NL 23753 19981210; FIRST REGISTRATION: SE - 14 007 19980306 |
1519731 | PA2013023 | Lithuania | ⤷ Subscribe | PRODUCT NAME: AZELASTINUM HYDROCHLORICUM + FLUTICASONUM PROPIONICUM; REGISTRATION NO/DATE: LT/1/13/3227/001 - LT/1 3/3227/004 |
1280520 | C300722 | Netherlands | ⤷ Subscribe | PRODUCT NAME: TOBRAMYCINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: C(2011)5394 20110720 |
0770388 | 2009/012 | Ireland | ⤷ Subscribe | PRODUCT NAME: QLAIRA-ESTRADIOL VALERATE/DIENOGEST; NAT REGISTRATION NO/DATE: PA1410/58/1 20090109; FIRST REGISTRATION NO/DATE: BE327792 20081103 |
1519731 | 1390033-7 | Sweden | ⤷ Subscribe | PRODUCT NAME: AZELASTIN, ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV, OCH EN FARMACEUTISKT GODTAGBAR ESTER AV FLUTIKASON; NAT. REG. NO/DATE: MTNR 47084 20130221; FIRST REG.: SK 24/0055/13-S 20130215 |
0770388 | 9/2009 | Austria | ⤷ Subscribe | PRODUCT NAME: KOMBINATION AUS ESTRADIOLVALERAT UND DIENOGEST; NAT. REGISTRATION NO/DATE: 1-28003 20090203; FIRST REGISTRATION: BE BE 327792 20081103 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.