Is there a generic for Tipranavir?

The FDA Orange Book does not currently list an approved generic (ANDA) for Tipranavir. It is available as 2 brand (NDA) applications.

What is the reference-listed drug for Tipranavir?

APTIVUS (NDA 022292, BOEHRINGER INGELHEIM) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What dosage forms of Tipranavir are approved?

Tipranavir is approved in the following dosage forms: capsule, solution.

FDA Orange Book · active-ingredient family

Tipranavir

Tipranavir is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.

Reference-listed drug:APTIVUS · NDA 022292

Brand (NDA)

Generics (ANDA)

Listed patents

Exclusivity periods

Brand (NDA) products · capsule, solution

Product	Applicant	Application	TE	Approved
APTIVUSRLD	BOEHRINGER INGELHEIM	NDA 022292	—	Jun 23, 2008
APTIVUSRLD	BOEHRINGER INGELHEIM	NDA 021814	—	Jun 22, 2005

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Tipranavir — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

Book a Demo