MYLAN Company Profile
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What is the competitive landscape for MYLAN, and what generic alternatives to MYLAN drugs are available?
MYLAN has four hundred and twenty-one approved drugs.
There are forty-two US patents protecting MYLAN drugs. There are forty-one tentative approvals on MYLAN drugs.
There are two hundred and fifty-two patent family members on MYLAN drugs in forty-one countries and nine hundred and twenty supplementary protection certificates in eighteen countries.
Summary for MYLAN
International Patents: | 252 |
US Patents: | 42 |
Tradenames: | 343 |
Ingredients: | 315 |
NDAs: | 421 |
Patent Litigation for MYLAN: | See patent lawsuits for MYLAN |
PTAB Cases with MYLAN as petitioner: | See PTAB cases with MYLAN as petitioner |
Drugs and US Patents for MYLAN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan Institutional | PROMETHAZINE HYDROCHLORIDE | promethazine hydrochloride | INJECTABLE;INJECTION | 040471-001 | Nov 21, 2002 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | |||||
Mylan | EVEROLIMUS | everolimus | TABLET, FOR SUSPENSION;ORAL | 210130-001 | Apr 19, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ||||
Mylan Speciality Lp | MUSE | alprostadil | SUPPOSITORY;URETHRAL | 020700-004 | Nov 19, 1996 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | |||||
Mylan | PENICILLIN V POTASSIUM | penicillin v potassium | FOR SOLUTION;ORAL | 061624-001 | Approved Prior to Jan 1, 1982 | DISCN | No | 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 MYLAN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Mylan Speciality Lp | MUSE | alprostadil | SUPPOSITORY;URETHRAL | 020700-004 | Nov 19, 1996 | 4,801,587 | ⤷ Sign Up |
Mylan Speciality Lp | TOBI PODHALER | tobramycin | POWDER;INHALATION | 201688-001 | Mar 22, 2013 | 8,069,851 | ⤷ Sign Up |
Mylan Speciality Lp | MUSE | alprostadil | SUPPOSITORY;URETHRAL | 020700-004 | Nov 19, 1996 | 5,474,535 | ⤷ Sign Up |
Mylan Speciality Lp | FELBATOL | felbamate | SUSPENSION;ORAL | 020189-003 | Jul 29, 1993 | 4,978,680 | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
Paragraph IV (Patent) Challenges for MYLAN drugs
Drugname | Dosage | Strength | Tradename | Submissiondate |
---|---|---|---|---|
➤ Subscribe | Injection | 100 mg/mL, 2.5 mL vials | ➤ Subscribe | 2007-09-24 |
➤ Subscribe | for Injection | 1 mg/vial, 2 mg/vial and 5 mg/vial | ➤ Subscribe | 2013-12-27 |
➤ 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 | for Injection | 200 mcg/vial | ➤ Subscribe | 2015-05-01 |
➤ Subscribe | Injection | 1 mg/mL, 50 mL vials | ➤ Subscribe | 2011-12-16 |
➤ 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 |
➤ Subscribe | CapsulesInhalation Solution | 0.02 mg/2 mL | ➤ Subscribe | 2009-01-21 |
➤ Subscribe | for Injection | 100 mcg/vial and 500 mcg/vial | ➤ Subscribe | 2015-04-14 |
International Patents for MYLAN Drugs
Country | Patent Number | Estimated Expiration |
---|---|---|
Cyprus | 1115386 | ⤷ Sign Up |
European Patent Office | 1615689 | ⤷ Sign Up |
Poland | 1786491 | ⤷ Sign Up |
Hong Kong | 1097537 | ⤷ Sign Up |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for MYLAN Drugs
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1915993 | 300625 | Netherlands | ⤷ Sign Up | PRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414 |
1189916 | C300477 | Netherlands | ⤷ Sign Up | PRODUCT NAME: REGADENOSON ALSMEDE FARMACEUTISCHE AANVAARDBARE ZOUTEN DAARVAN; REGISTRATION NO/DATE: EU/1/10/643/001 20100906 |
2498758 | 122020000018 | Germany | ⤷ Sign Up | PRODUCT NAME: METFORMIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; SAXAGLIPTIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; DAPAGLIFLOZIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/19/1401 20191111 |
0398460 | SPC/GB04/032 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: ESTRADIOL, OPTIONALLY IN THE FORM OF A HYDRATE, TOGETHER WITH DROSPIRENONE; REGISTERED: NL RVG 27505 20021211; UK PL 00053/0341 20040310 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Similar Applicant Names
Here is a list of applicants with similar names.